Participants’ experiences from group-based treatment at multidisciplinary pain centres - a qualitative study

Abstract Objectives The aim of the study was to explore the experiences of participants in non-pharmacological group-based treatments delivered as part of a randomised controlled trial at Norwegian tertiary care pain centres. Methods Individual semi-structured interviews with 15 persons were conducted. The data were analysed with a descriptive thematic cross-case analysis based on the method of systematic text condensation. Results All participants talked about some aspects of the group-based treatments as a positive experience, but mainly the outcome was in line with their expectations; they hoped it would reduce their pain but did not expect it. There were no clear-cut differences in the experiences between the participants from the two different intervention groups. The content was experienced as both relevant and interesting but also to introduce concepts that were difficult to grasp and understand. Similarly, the experiences of participating in a group-based treatment were mostly stimulating but could also be challenging because of an expectancy of sharing personal stories. Although experiencing few changes to their pain they came away with techniques and lessons that were valuable to them. Conclusions In this study, taking part in group-based treatment was perceived as giving positive and valuable lessons, due to relevant content and learning from the professionals and fellow participants, but without any clear indication of reduced pain. Approval from ethical committee number 10260 REK Midt. Trial registration number ClinicalTrials.gov NCT04057144.

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Intravenous cefazolin plus oral probenecid versus oral cephalexin for the treatment of skin and soft tissue infections: a double-blind, non-inferiority, randomised controlled trial

Emergency Medicine Journal ◽

10.1136/emermed-2017-207420 ◽

2018 ◽

Vol 35 (8) ◽

pp. 492-498 ◽

Cited By ~ 1

Author(s):

Dawn Dalen ◽

Amy Fry ◽

Samuel G Campbell ◽

Jeffrey Eppler ◽

Peter J Zed

Keyword(s):

Soft Tissue ◽

Clinical Cure ◽

Controlled Trial ◽

Tertiary Care ◽

Risk Difference ◽

Teaching Hospitals ◽

Double Blind ◽

Treatment Groups ◽

Registration Number ◽

Randomised Controlled

ObjectiveThe purpose of our study was to determine if cephalexin 500 mg orally four times daily was non-inferior to cefazolin 2 g intravenously daily plus probenecid 1 g orally daily in the management of patients with uncomplicated mild–moderate skin and soft tissue infection (SSTI) presenting to the ED.MethodsThis was a prospective, multicentre, double dummy-blind, randomised controlled non-inferiority trial conducted at two tertiary care teaching hospitals in Canada. Patients were enrolled if they presented to the ED with an uncomplicated SSTI, and randomly assigned in a 1:1 fashion to oral cephalexin or intravenous cefazolin plus oral probenecid for up to 7 days. The primary outcome was failure of therapy at 72 hours. Clinical cure at 7 days, intravenous to oral medication transition admission to hospital and adverse events were also evaluated.Results206 patients were randomised with 104 patients in the cephalexin group and 102 in the cefazolin and probenecid group. The proportion of patients failing therapy at 72 hours was similar between the treatment groups (4.2% and 6.1%, risk difference 1.9%, 95% CI −3.7% to 7.6%). Clinical cure at 7 days was not significantly different (100% and 97.7%, risk difference −2.3%, 95% CI −6.7% to 0.8%).ConclusionCephalexin at appropriate doses appears to be a safe and effective alternative to outpatient parenteral cefazolin in the treatment of uncomplicated mild–moderate SSTIs who present to the ED.Trial registration numberNCT01029782; Results.

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Improvement of perioperative care of the elderly patient (PeriAge): protocol of a controlled interventional feasibility study

BMJ Open ◽

10.1136/bmjopen-2019-031837 ◽

2019 ◽

Vol 9 (11) ◽

pp. e031837

Author(s):

Cynthia Olotu ◽

Lisa Lebherz ◽

Martin Härter ◽

Anna Mende ◽

Lili Plümer ◽

...

Keyword(s):

Postoperative Complications ◽

Scientific Practice ◽

Controlled Trial ◽

The Elderly ◽

Structured Interviews ◽

Related Quality ◽

Registration Number ◽

Health Related ◽

Randomised Controlled ◽

Protocol Study

IntroductionGeriatric patients have a pronounced risk to suffer from postoperative complications. While effective risk-specific perioperative measures have been studied in controlled experimental settings, they are rarely found in routine healthcare. This study aims (1) to implement a multicomponent preoperative and intraoperative intervention, and investigate its feasibility, and (2) exploratorily assess the effectiveness of the intervention in routine healthcare.Methods and analysisFeasibility and exploratory effectiveness of the intervention will be investigated in a monocentric, prospective, non-randomised, controlled trial. The intervention includes systematic information for patients and family about measures to prevent postoperative complications; preoperative screening for frailty, malnutrition, strength and mobility with nutrient supplementation and physical exercise (prehabilitation) as needed. Further components focus on potentially inadequate medication, patient blood-management and carbohydrate loading prior to surgery, retainment of orientation aids in the operating room and a geriatric anaesthesia concept. Data will successively be collected from control, implementation and intervention groups. Patients aged 65+ with impending surgery will be included. A sample size of 240, n=80 per group, is planned. Assessments will take place at inclusion and 2, 30 and 180 days after surgery. Mixed-methods analyses will be performed. Exploratory effectiveness will be assessed using mixed segmented regressions. The primary endpoint is functional status. Secondary endpoints include cognitive performance, health-related quality of life, length of inpatient stay and occurrence of postoperative complications. Feasibility will be assessed through semi-structured interviews with staff and patients and quantitative analyses of the data quality, focussing on practicability, acceptance, adoption and fidelity to protocol.Ethics and disseminationThe study will be carried out in accordance with the Helsinki Declaration and to principles of good scientific practice. The Ethics Committee of the Medical Association Hamburg, Germany, approved the protocol (study ID: PV5596). Results will be disseminated in scientific journals and healthcare conferences.Trial registration numberClinicalTrials.gov Identifier: NCT03325413.

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Camp-based family treatment of childhood obesity: randomised controlled trial

Archives of Disease in Childhood ◽

10.1136/archdischild-2015-309813 ◽

2016 ◽

Vol 102 (4) ◽

pp. 303-310 ◽

Cited By ~ 6

Author(s):

Beate Benestad ◽

Samira Lekhal ◽

Milada Cvancarova Småstuen ◽

Jens Kristoffer Hertel ◽

Vidar Halsteinli ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Summer Camp ◽

Controlled Trial ◽

Tertiary Care ◽

Family Treatment ◽

Care Hospital ◽

Treatment Programme ◽

Registration Number ◽

Family Based ◽

Randomised Controlled

ObjectiveTo compare the effectiveness of a 2-year camp-based family treatment programme and an outpatient programme on obesity in two generations.DesignPragmatic randomised controlled trial.SettingRehabilitation clinic, tertiary care hospital and primary care.PatientsFamilies with at least one child (7–12 years) and one parent with obesity.InterventionsSummer camp for 2 weeks and 4 repetition weekends or lifestyle school including 4 days family education. Behavioural techniques motivating participants to healthier lifestyle.Main outcome measuresChildren: 2-year changes in body mass index (BMI) SD score (SDS). Parents: 2-year change in BMI. Main analyses: linear mixed models.ResultsNinety children (50% girls) were included. Baseline mean (SD) age was 9.7 (1.2) years, BMI 28.7 (3.9) kg/m2 and BMI SDS 3.46 (0.75). The summer-camp children had a lower adjusted estimated mean (95% CI) increase in BMI (−0.8 (−3.5 to −0.2) kg/m2), but the BMI SDS reductions did not differ significantly (−0.11 (−0.49 to 0.05)). The 2-year baseline adjusted BMI and BMI SDS did not differ significantly between summer-camp and lifestyle-school completers, BMI 29.8 (29.1 to 30.6) vs 30.7 (29.8 to 31.6) kg/m2 and BMI SDS 2.96 (2.85 to 3.08) vs 3.11 (2.97 to 3.24), respectively. The summer-camp parents had a small reduction in BMI (−0.9 (−1.8 to −0.03) vs −0.8 (−2.1 to 0.4) in the lifestyle-school group), but the within-group changes did not differ significantly (0.3 (−1.7 to 2.2)).ConclusionsA 2-year family camp-based obesity treatment programme had no significant effect on BMI SDS in children with severe obesity compared with an outpatient family-based treatment programme.Trial registration numberNCT01110096.

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Experiences in physical activity promotion in health care settings for primary prevention in the UK

Swiss Sports & Exercise Medicine ◽

10.34045/ssem/2014/11 ◽

2014 ◽

Vol 62 (2) ◽

Keyword(s):

Physical Activity ◽

Primary Care ◽

Health Professionals ◽

Controlled Trial ◽

Full Range ◽

Tertiary Care ◽

Physical Activity Promotion ◽

Community Based ◽

Activity Promotion ◽

Randomised Controlled

In addition to the delivery of primary care services, recent changes to the NHS in the United Kingdom have placed increasing responsibility on GPs for the commissioning of the full range of health services from prevention through to clinical interventions and rehabilitation. Whilst historically there has always been an expectation that primary care professionals were ideally placed to provide support for prevention as well as treatment, their active engagement in the promotion of physical activity has remained largely superficial. With notable exceptions where individuals have a personal interest or commitment, the majority of health professionals tend to limit themselves to peremptory non-specific advice at best, or frequently don’t broach the subject at all. There are a number of reasons for this including increasing time pressures, a general lack of knowledge, limited evidence and concerns about litigation in the event of an adverse exercise induced event. However in the 1990s there was a surge of interest in the emerging “Exercise on Prescription” model where patients could be referred to community based exercise instructors for a structured “prescription” of exercise in community leisure centres. Despite the continuing popularity of the model there remain problems particularly in getting the active support of health professionals who generally cite the same barriers as previously identified. In an attempt to overcome some of these problems Wales established a national exercise referral scheme with an associated randomised controlled trial. The scheme evaluated well and had subsequently evolved with new developments including integration with secondary and tertiary care pathways, accredited training for exercise instructors and exit routes into alternative community based exercise opportunities.

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Effect of intensive treatment for schistosomiasis on immune responses to vaccines among rural Ugandan island adolescents: randomised controlled trial protocol A for the ‘POPulation differences in VACcine responses’ (POPVAC) programme

BMJ Open ◽

10.1136/bmjopen-2020-040426 ◽

2021 ◽

Vol 11 (2) ◽

pp. e040426

Author(s):

Gyaviira Nkurunungi ◽

Ludoviko Zirimenya ◽

Jacent Nassuuna ◽

Agnes Natukunda ◽

Prossy N Kabuubi ◽

...

Keyword(s):

Immune Responses ◽

Low Income ◽

Controlled Trial ◽

Interferon Γ ◽

Population Differences ◽

Vaccine Response ◽

Vaccine Responses ◽

Helminth Infections ◽

Registration Number ◽

Randomised Controlled

IntroductionSeveral licensed and investigational vaccines have lower efficacy, and induce impaired immune responses, in low-income versus high-income countries and in rural, versus urban, settings. Understanding these population differences is essential to optimising vaccine effectiveness in the tropics. We suggest that repeated exposure to and immunomodulation by chronic helminth infections partly explains population differences in vaccine response.Methods and analysisWe have designed an individually randomised, parallel group trial of intensive versus standard praziquantel (PZQ) intervention against schistosomiasis, to determine effects on vaccine response outcomes among school-going adolescents (9–17 years) from rural Schistosoma mansoni-endemic Ugandan islands. Vaccines to be studied comprise BCG on day ‘zero’; yellow fever, oral typhoid and human papilloma virus (HPV) vaccines at week 4; and HPV and tetanus/diphtheria booster vaccine at week 28. The intensive arm will receive PZQ doses three times, each 2 weeks apart, before BCG immunisation, followed by a dose at week 8 and quarterly thereafter. The standard arm will receive PZQ at week 8 and 52. We expect to enrol 480 participants, with 80% infected with S. mansoni at the outset.Primary outcomes are BCG-specific interferon-γ ELISpot responses 8 weeks after BCG immunisation and for other vaccines, antibody responses to key vaccine antigens at 4 weeks after immunisation. Secondary analyses will determine the effects of intensive anthelminthic treatment on correlates of protective immunity, on waning of vaccine response, on priming versus boosting immunisations and on S. mansoni infection status and intensity. Exploratory immunology assays using archived samples will enable assessment of mechanistic links between helminths and vaccine responses.Ethics and disseminationEthics approval has been obtained from relevant ethics committes of Uganda and UK. Results will be shared with Uganda Ministry of Health, relevant district councils, community leaders and study participants. Further dissemination will be done through conference proceedings and publications.Trial registration numberISRCTN60517191.

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Estimating the minimum important difference in the DEMQOL instrument in people with dementia

Quality of Life Research ◽

10.1007/s11136-021-02900-7 ◽

2021 ◽

Author(s):

Ellen C. Lee ◽

Jessica Wright ◽

Stephen J. Walters ◽

Cindy L. Cooper ◽

Gail A. Mountain

Keyword(s):

Quality Of Life ◽

Controlled Trial ◽

Minimum Important Difference ◽

Absolute Change ◽

People With Dementia ◽

Related Quality ◽

Registration Number ◽

Clinically Significant ◽

Randomised Controlled

Abstract Purpose The Dementia-Related Quality of Life (DEMQOL) measure and the DEMQOL-Utility Score (DEMQOL-U) are validated tools for measuring quality of life (QOL) in people with dementia. What score changes translate to a clinically significant impact on patients’ lives was unknown. This study establishes the minimal important differences (MID) for these two instruments. Methods Anchor-based and distribution-based methods were used to estimate the MID scores from patients enrolled in a randomised controlled trial. For the anchor-based method, the global QOL (Q29) item from the DEMQOL was chosen as the anchor for DEMQOL and both Q29 and EQ-5D for DEMQOL-U. A one category difference in Q29, and a 0.07 point difference in EQ-5D score, were used to classify improvement and deterioration, and the MID scores were calculated for each category. These results were compared with scores obtained by the distribution-based methods. Results A total of 490 people with dementia had baseline DEMQOL data, of these 386 had 8-month data, and 344 had 12-month DEMQOL data. The absolute change in DEMQOL for a combined 1-point increase or decrease in the Q29 anchor was 5.2 at 8 months and 6.0 at 12 months. For the DEMQOL-U, the average absolute change at 8 and 12 months was 0.032 and 0.046 for the Q29 anchor and 0.020 and 0.024 for EQ-5D anchor. Conclusion We present MID scores for the DEMQOL and DEMQOL-U instruments obtained from a large cohort of patients with dementia. An anchored-based estimate of the MID for the DEMQOL is around 5 to 6 points; and 0.02 to 0.05 points for the DEMQOL-U. The results of this study can guide clinicians and researchers in the interpretation of these instruments comparisons between groups or within groups of people with dementia. Trial Registration Number and date of registration: ISRCTN17993825 on 11th October 2016.

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Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-039981 ◽

2021 ◽

Vol 11 (1) ◽

pp. e039981

Author(s):

Maleea Denise Holbert ◽

Roy M Kimble ◽

Mark Chatfield ◽

Bronwyn R Griffin

Keyword(s):

Randomised Controlled Trial ◽

Repeated Measures ◽

Controlled Trial ◽

Geometric Mean ◽

First Aid ◽

Self Report ◽

Thermal Burn ◽

Pain Scores ◽

Registration Number ◽

Randomised Controlled

ObjectiveTo compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.DesignSingle-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.Participants and settingPaediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children’s Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017–September 2018.InterventionsPatients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.Primary and secondary outcomesObservational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.ResultsSeventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: −0.1, 95% CI −0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI −8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI −1.7 to 2.2, p=0.78), heart rate (MD: −3, 95% CI −11 to 5, p=0.41), temperature (MD: 0.6, 95% CI −0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: −1, 95% CI −3 to 1, p=0.26) were identified between the two groups.ConclusionsA clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001274369).

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Open-label placebo for insomnia (OPIN): study protocol for a cohort multiple randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-044045 ◽

2021 ◽

Vol 11 (2) ◽

pp. e044045

Author(s):

Ben Colagiuri ◽

Louise Sharpe ◽

Zahava Ambarchi ◽

Nick Glozier ◽

Delwyn Bartlett ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Treatment Period ◽

Controlled Trial ◽

Severity Index ◽

Open Label ◽

Human Research Ethics ◽

Sleep Parameters ◽

Registration Number ◽

Randomised Controlled ◽

Insomnia Symptoms

IntroductionInsomnia is a prevalent sleep disorder that causes substantial personal and societal harm. There is evidence that placebo interventions can reduce insomnia symptoms, but this research has involved deceptively administering the placebo under the guise of a real medication (conventional placebo, CP), which has obvious ethical constraints. Open-label placebo (OLP) treatment, in which a placebo is administered with full disclosure that there are no active ingredients, has been proposed as a method of using the placebo effect ethically, but the efficacy and acceptability of OLP for insomnia is currently unknown.Methods and analysisThis study uses a cohort multiple randomised controlled trial design to compare OLP, CP and no treatment for insomnia. Two-hundred and sixty-seven participants with self-reported insomnia symptoms (Insomnia Severity Index, ISI ≥10) will be recruited into an observational study and have their sleep monitored over a 2-week period. Participants will then be randomised to one of three groups: invite to OLP, invite to CP described deceptively as a new pharmacological agent, or no invite/observational control. Those in OLP and CP accepting the invite receive identical placebos for a 2-week treatment period while sleep is monitored in all participants. The primary outcome is ISI at the end of the treatment period. Secondary outcomes include treatment uptake and clinically significant response rates, objective and subjective sleep parameters, fatigue, mood, expectancy, treatment satisfaction and side effects. Predictors of uptake and responses to OLP and CP will be explored.Ethics and disseminationThe trial has been approved by The University of Sydney Human Research Ethics Committee. Written informed consent is obtained from every participant. OLP and CP participants accepting the invite undergo an additional consent process. Results will be disseminated via peer-reviewed conference proceedings and publications.Trial registration numberACTRN12620001080910.

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A multicentre randomised controlled trial to compare the pharmacokinetics, efficacy and safety of CT-P10 and innovator rituximab in patients with rheumatoid arthritis

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2016-209540 ◽

2016 ◽

Vol 76 (3) ◽

pp. 566-570 ◽

Cited By ~ 52

Author(s):

Dae Hyun Yoo ◽

Chang-Hee Suh ◽

Seung Cheol Shim ◽

Slawomir Jeka ◽

Francisco Fidencio Cons-Molina ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Serum Concentration ◽

Controlled Trial ◽

Comparable Efficacy ◽

Pharmacokinetic Parameters ◽

Time Curve ◽

Maximum Serum ◽

Primary Endpoints ◽

Registration Number ◽

Randomised Controlled

ObjectiveTo demonstrate pharmacokinetic equivalence of CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA) with inadequate responses or intolerances to antitumour necrosis factor agents.MethodsIn this randomised phase I trial, patients with active RA were randomly assigned (2:1) to receive 1000 mg CT-P10 or RTX at weeks 0 and 2 (alongside continued methotrexate therapy). Primary endpoints were area under the serum concentration–time curve from time zero to last quantifiable concentration (AUC0–last) and maximum serum concentration after second infusion (Cmax). Additional pharmacokinetic parameters, efficacy, pharmacodynamics, immunogenicity and safety were also assessed. Data are reported up to week 24.Results103 patients were assigned to CT-P10 and 51 to RTX. The 90% CIs for the ratio of geometric means (CT-P10/RTX) for both primary endpoints were within the bioequivalence range of 80%–125% (AUC0–last: 97.7% (90% CI 89.2% to 107.0%); Cmax: 97.6% (90% CI 92.0% to 103.5%)). Pharmacodynamics and efficacy were comparable between groups. Antidrug antibodies were detected in 17.6% of patients in each group at week 24. CT-P10 and RTX displayed similar safety profiles.ConclusionsCT-P10 and RTX demonstrated equivalent pharmacokinetics and comparable efficacy, pharmacodynamics, immunogenicity and safety.Trial registration numberNCT01534884.

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Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate)

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2017-211682 ◽

2017 ◽

Vol 77 (2) ◽

pp. 212-220 ◽

Cited By ~ 111

Author(s):

Dinesh Khanna ◽

Christopher P Denton ◽

Celia J F Lin ◽

Jacob M van Laar ◽

Tracy M Frech ◽

...

Keyword(s):

Systemic Sclerosis ◽

Phase Ii ◽

Controlled Trial ◽

Safety Data ◽

Open Label ◽

Double Blind ◽

Skin Score ◽

Open Label Extension ◽

Registration Number ◽

Randomised Controlled

ObjectivesAssess the efficacy and safety of tocilizumab in patients with systemic sclerosis (SSc) in a phase II study.MethodsPatients with SSc were treated for 48 weeks in an open-label extension phase of the faSScinate study with weekly 162 mg subcutaneous tocilizumab. Exploratory end points included modified Rodnan Skin Score (mRSS) and per cent predicted forced vital capacity (%pFVC) through week 96.ResultsOverall, 24/44 (55%) placebo-tocilizumab and 27/43 (63%) continuous-tocilizumab patients completed week 96. Observed mean (SD (95% CI)) change from baseline in mRSS was –3.1 (6.3 (–5.4 to –0.9)) for placebo and –5.6 (9.1 (–8.9 to–2.4)) for tocilizumab at week 48 and –9.4 (5.6 (–8.9 to –2.4)) for placebo-tocilizumab and –9.1 (8.7 (–12.5 to –5.6)) for continuous-tocilizumab at week 96. Of patients who completed week 96, any decline in %pFVC was observed for 10/24 (42% (95% CI 22% to 63%)) placebo-tocilizumab and 12/26 (46% (95% CI 27% to 67%)) continuous-tocilizumab patients in the open-label period; no patients had >10% absolute decline in %pFVC. Serious infection rates/100 patient-years (95% CI) were 10.9 (3.0 to 27.9) with placebo and 34.8 (18.0 to 60.8) with tocilizumab during the double-blind period by week 48 and 19.6 (7.2 to 42.7) with placebo-tocilizumab and 0.0 (0.0 to 12.2) with continuous-tocilizumab during the open-label period.ConclusionsSkin score improvement and FVC stabilisation in the double-blind period were observed in placebo-treated patients who transitioned to tocilizumab and were maintained in the open-label period. Safety data indicated increased serious infections in patients with SSc but no new safety signals with tocilizumab.Trial registration numberNCT01532869; Results.

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