Feasibility and acceptability of daily testing at school as an alternative to self-isolation following close contact with a confirmed case of COVID-19: A qualitative analysis

Background Daily testing using a rapid Lateral Flow Device (LFD) has been suggested as an alternative to self-isolation. A randomised trial comparing daily contact testing (DCT) in schools with self-isolation found that SARS-CoV-2 transmission within school was comparable and low in both groups. However, if this approach is to be adopted widely, it is critical that we understand the perspective of those who will be delivering and receiving DCT. The aim of this qualitative process study embedded in the randomised controlled trial (RCT) was to improve understanding of a range of behavioural factors that could influence implementation. Methods Interviews were conducted with 63 participants, including staff, students, and parents of students who had been identified as being in close contact with someone with COVID-19. The topic guide explored perceptions of daily testing, understanding of positive and negative test results, and adherence to guidance. Data were analysed using an inductive thematic approach. Results Results were organised under three main headings: (1) factors influencing daily testing (2) interpretation of test results (3) behaviour during testing period. Participants recognized that daily testing may allow students to remain in school, which was viewed as necessary for both education and social needs. Whilst some felt safer as a result of daily testing, others raised concerns about safety. Participants did not always understand how to interpret and respond to test results, and although participants reported high levels of adherence to the guidance, improved communications were desired. Conclusion Daily testing may be a feasible and acceptable alternative to self-isolation among close contacts of people who test positive. However, improved communications are needed to ensure that all students and parents have a good understanding of the rationale for testing, what test results mean, how test results should be acted on, and how likely students are to test positive following close contact. Support is needed for students and parents of students who have to self-isolate and for those who have concerns about the safety of daily testing.

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Web-based early intervention for children with motor difficulties aged 3–8 years old using multimodal rehabilitation (WECARE): protocol of a patient-centred pragmatic randomised trial of paediatric telerehabilitation to support families

BMJ Open ◽

10.1136/bmjopen-2020-046561 ◽

2021 ◽

Vol 11 (4) ◽

pp. e046561

Author(s):

Chantal Camden ◽

Jill G Zwicker ◽

Melanie Morin ◽

Tibor Schuster ◽

Melanie Couture ◽

...

Keyword(s):

Early Intervention ◽

Controlled Trial ◽

Randomised Trial ◽

Parental Knowledge ◽

Performance Measure ◽

Performance Goals ◽

Web Based ◽

Study Results ◽

Motor Difficulties ◽

Randomised Controlled

IntroductionMild motor difficulties in children are underdiagnosed despite being highly prevalent, leaving such children often underserved and at higher risk for secondary consequences such as cardiovascular disease and anxiety. Evidence suggests that early patient-oriented interventions, coaching parents and providing children with early stimulation should be provided, even in the absence of a diagnosis. Such interventions may be effectively delivered via telerehabilitation.Methods and analysisA family-centred, pragmatic randomised controlled trial will be carried out to evaluate the real-world effectiveness of a Web-based Early intervention for Children using multimodAl REhabilitation (WECARE). Families of children with motor difficulties, 3–8 years of age, living in Quebec, Canada, and receiving no public rehabilitation services (n=118) will be asked to determine up to 12 performance goals, evaluated using the Canadian Occupational Performance Measure (COPM, the primary outcome). Families will be randomised to receive either usual care or the WECARE intervention. The WECARE intervention will be delivered for 1 year via a web-based platform. Families will have access to videoconferences with an assigned rehabilitation therapist using a collaborative coaching approach, a private chat function, a forum open to all intervention arm participants and online resources pertaining to child development. Participants will be asked to re-evaluate the child’s COPM performance goals every 3 months up to 1 year post allocation. The COPM results will be analysed using a mixed Poisson regression model. Secondary outcomes include measures of the child’s functional ability, parental knowledge and skills and health-related quality of life, as well as qualitative outcomes pertaining to parental satisfaction and service delivery trajectories. Investigators and quantitative data analysts will be blinded to group allocation.Ethics and disseminationThe CIUSSS de l’Estrie—CHUS ethics committee approved this trial (2020-3429). Study results will be communicated via peer-reviewed journal publications, conference presentations and stakeholder-specific knowledge transfer activities.Trial registration numberNCT04254302.

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Methods for delivering the UK's multi-centre prison-based naloxone-on-release pilot randomised trial (N-ALIVE): Europe's largest prison-based randomised controlled trial

Drug and Alcohol Review ◽

10.1111/dar.12592 ◽

2017 ◽

Vol 37 (4) ◽

pp. 487-498 ◽

Cited By ~ 4

Author(s):

Angela Mary Meade ◽

Sheila Macdonald Bird ◽

John Strang ◽

Tracey Pepple ◽

Laura Lea Nichols ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Randomised Trial ◽

Randomised Controlled

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Predictors of employment for people with severe mental illness: results of an international six-centre randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.107.041475 ◽

2008 ◽

Vol 192 (3) ◽

pp. 224-231 ◽

Cited By ~ 128

Author(s):

Jocelyn Catty ◽

Pascale Lissouba ◽

Sarah White ◽

Thomas Becker ◽

Robert E. Drake ◽

...

Keyword(s):

Mental Illness ◽

Randomised Controlled Trial ◽

Severe Mental Illness ◽

Controlled Trial ◽

Patient Characteristics ◽

Employment Outcomes ◽

Social Needs ◽

Vocational Outcomes ◽

Randomised Controlled ◽

Ips Model

BackgroundAn international six-centre randomised controlled trial comparing individual placement and support (IPS) with usual vocational rehabilitation for people with serious mental illness found IPS to be more effective for all vocational outcomes.AimsTo determine which patients with severe mental illness do well in vocational services and which process and service factors are associated with better outcomes.MethodPatient characteristics and early process variables were tested as predictors of employment outcomes. Service characteristics were explored as predictors of the effectiveness of IPS.ResultsPatients with previous work history, fewer met social needs and better relationships with their vocational workers were more likely to obtain employment and work for longer. Remission and swifter service uptake were associated with working more. Having an IPS service closer to the original IPS model was the only service characteristic associated with greater effectiveness.ConclusionsThe IPS service was found to be more effective for all vocational outcomes. In addition, maintaining high IPS fidelity and targeting relational skills would be a valuable focus for all vocational interventions, leading to improved employment outcomes. Motivation to find work may be decreased by satisfaction with current life circumstances.

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Efficacy and Safety of Lianhuaqingwen Capsules for the Prevention of Coronavirus Disease 2019: A Prospective Open-Label Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2021/7962630 ◽

2021 ◽

Vol 2021 ◽

pp. 1-9

Author(s):

Xiaowei Gong ◽

Boyun Yuan ◽

Yadong Yuan ◽

Fengju Li

Keyword(s):

Nucleic Acid ◽

Treatment Group ◽

Close Contact ◽

Controlled Trial ◽

Control Group ◽

Open Label ◽

Medical Observation ◽

Observation Period ◽

Close Contacts ◽

Nucleic Acid Tests

Coronavirus disease 2019 (COVID-19) has become a global pandemic. Community and close contact exposures continue to drive the COVID-19 pandemic. There is no confirmed effective treatment for suspected cases and close contacts. Lianhuaqingwen (LH) capsules, a repurposed Chinese herbal product that is currently on the market, have proven effective for influenza and COVID-19. To determine the safety and efficacy of LH capsules for the prevention of COVID-19, we conducted a prospective open-label controlled trial of LH capsules on subjects who had close contact with people infected with COVID-19. Subjects received LH capsules (4 capsules, three times daily) or the usual medical observation for 14 days. The primary endpoint was the rate of positive nucleic acid tests of nasal and pharyngeal swabs during the quarantine medical observation period. We included 1976 patients, including 1101 in the treatment group and 875 in the control group. The rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.27% vs. 1.14%, respectively; mean difference: −0.87%; 95% CI: −1.83 to −0.13; p = 0.0174 ) during the quarantine medical observation period (14 days). Among subjects with different close contact states, there was no significant difference in the rate of positive nucleic acid test results among close contacts in the treatment group and the control group (6.45% vs. 11.43%, respectively; p = 0.6762 ). Among secondary close contacts, the rate of positive nucleic acid tests in the treatment group was significantly lower than that in the control group (0.09% vs. 0.71%, respectively; p = 0.0485 ). No serious adverse events were reported. Taken together, and in light of the safety and effectiveness profiles, these results show that LH capsules can be considered to prevent the progression of COVID-19 after close contact with an infected person. This trial is registered with ChiCTR2100043012.

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Drooling Reduction Intervention randomised trial (DRI): comparing the efficacy and acceptability of hyoscine patches and glycopyrronium liquid on drooling in children with neurodisability

Archives of Disease in Childhood ◽

10.1136/archdischild-2017-313763 ◽

2017 ◽

Vol 103 (4) ◽

pp. 371-376 ◽

Cited By ~ 12

Author(s):

Jeremy R Parr ◽

Emma Todhunter ◽

Lindsay Pennington ◽

Deborah Stocken ◽

Jill Cadwgan ◽

...

Keyword(s):

Side Effects ◽

Controlled Trial ◽

Symptom Control ◽

Randomised Trial ◽

Frequency Scale ◽

Skin Patch ◽

Impact Scale ◽

Significant Difference ◽

Secondary Outcomes ◽

Randomised Controlled

ObjectiveInvestigate whether hyoscine patch or glycopyrronium liquid is more effective and acceptable to treat drooling in children with neurodisability.DesignMulticentre, single-blind, randomised controlled trial.SettingRecruitment through neurodisability teams; treatment by parents.ParticipantsNinety children with neurodisability who had never received medication for drooling (55 boys, 35 girls; median age 4 years). Exclusion criteria: medication contraindicated; in a trial that could affect drooling or management.InterventionChildren were randomised to receive a hyoscine skin patch or glycopyrronium liquid. Dose was increased over 4 weeks to achieve optimum symptom control with minimal side-effects; steady dose then continued to 12 weeks.Primary and secondary outcomesPrimary outcome: Drooling Impact Scale (DIS) score at week-4. Secondary outcomes: change in DIS scores over 12 weeks, Drooling Severity and Frequency Scale and Treatment Satisfaction Questionnaire for Medication; adverse events; children’s perception about treatment.ResultsBoth medications yielded clinically and statistically significant reductions in mean DIS at week-4 (25.0 (SD 22.2) for hyoscine and 26.6 (SD 16) for glycopyrronium). There was no significant difference in change in DIS scores between treatment groups. By week-12, 26/47 (55%) children starting treatment were receiving hyoscine compared with 31/38 (82%) on glycopyrronium. There was a 42% increased chance of being on treatment at week-12 for children randomised to glycopyrronium relative to hyoscine (1.42, 95% CI 1.04 to 1.95).ConclusionsHyoscine and glycopyrronium are clinically effective in treating drooling in children with neurodisability. Hyoscine produced more problematic side effects leading to a greater chance of treatment cessation.Trial registration numbersISRCTN75287237; EUDRACT: 2013-000863-94; Medicines and Healthcare Products Regulatory Agency: 17136/0264/001-0003

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Effects of injectable progestogen contraception versus the copper intrauterine device on HIV acquisition: sub-study of a pragmatic randomised controlled trial

Journal of Family Planning and Reproductive Health Care ◽

10.1136/jfprhc-2016-101607 ◽

2017 ◽

Vol 43 (3) ◽

pp. 175-180 ◽

Cited By ~ 10

Author(s):

G Justus Hofmeyr ◽

Mandisa Singata-Madliki ◽

Theresa A Lawrie ◽

Eduardo Bergel ◽

Marleen Temmerman

Keyword(s):

Randomised Controlled Trial ◽

South African ◽

Pregnancy Termination ◽

Controlled Trial ◽

Intrauterine Device ◽

Randomised Trial ◽

Contraceptive Device ◽

Increased Risk ◽

Hiv Acquisition ◽

Randomised Controlled

BackgroundEvidence from observational studies suggests an increased risk of HIV acquisition among women using depot medroxyprogesterone acetate (DMPA) contraception.MethodsWithin the context of a South African programme to increase women's access to the intrauterine contraceptive device (IUD), we conducted a pragmatic, open-label, parallel-arm, randomised controlled trial (RCT) of the IUD versus injectable progestogen contraception (IPC) at two South African hospitals. The primary outcome was pregnancy; secondary outcomes included HIV acquisition. Consenting women attending termination of pregnancy services were randomised after pregnancy termination between July 2009 and November 2012. Condoms were promoted for the prevention of sexually transmitted infections. Voluntary HIV testing was offered at baseline and at 12 or more months later. Findings on HIV acquisition are reported in this article.ResultsHIV acquisition data were available for 1290 initially HIV-negative women who underwent a final study interview at a median of 20 months after randomisation to IPC or an IUD. Baseline group characteristics were comparable. In the IPC group, 545/656 (83%) of participants received DMPA, 96 (15%) received injectable norethisterone enanthate, 14 (2%) received the IUD and one received oral contraception. In the IUD group 609 (96%) received the IUD, 20 (3%) received IPC and 5 (1%) had missing data. According to intention-to-treat analysis, HIV acquisition occurred in 20/656 (3.0%) women in the IPC arm and 22/634 (3.5%) women in the IUD arm (IPC vs IUD, risk ratio 0.88; 95% confidence interval 0.48–1.59;p=0.7).ConclusionsThis sub-study was underpowered to rule out moderate differences in HIV risk, but confirms the feasibility of randomised trial methodology to address this question. Larger RCTs are needed to determine the relative risks of various contraceptive methods on HIV acquisition with greater precision.Trial registration numberPan African Clinical Trials Registry number PACTR201409000880157 (04-09-2014).

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Longitudinal Study of music Therapy’s Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial

BMJ Open ◽

10.1136/bmjopen-2018-025062 ◽

2019 ◽

Vol 9 (8) ◽

pp. e025062 ◽

Cited By ~ 5

Author(s):

Claire Ghetti ◽

Łucja Bieleninik ◽

Mari Hysing ◽

Ingrid Kvestad ◽

Jörg Assmus ◽

...

Keyword(s):

Preterm Infants ◽

Neonatal Intensive Care ◽

Infant Development ◽

Controlled Trial ◽

Randomised Trial ◽

Developmentally Appropriate ◽

Well Being ◽

Positive Effects ◽

Implementation And Dissemination ◽

Randomised Controlled

IntroductionPreterm birth has major medical, psychological and socioeconomic consequences worldwide. Music therapy (MT) has positive effects on physiological measures of preterm infants and maternal anxiety, but rigorous studies including long-term follow-up are missing. Drawing on caregivers’ inherent resources, this study emphasises caregiver involvement in MT to promote attuned, developmentally appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalisation and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.Methods and analysisDesign:international multicentre, assessor-blind, 2×2 factorial, pragmatic randomised controlled trial; informed by a completed feasibility study.Participants:250 preterm infants and their parents.Intervention:MT focusing on parental singing specifically tailored to infant responses, will be delivered during NICU and/or during a postdischarge 6-month period.Primary outcome:changes in mother–infant bonding at 6-month corrected age (CA), as measured by the Postpartum Bonding Questionnaire.Secondary outcomes: mother–infant bonding at discharge and at 12-month CA; child development over 24 months; and parental depression, anxiety and stress, and infant rehospitalisation, all over 12 months.Ethics and disseminationThe Regional Committees for Medical and Health Research Ethics approved the study (2018/994/REK Nord, 03 July 2018). Service users were involved in development of the study and will be involved in implementation and dissemination. Dissemination of findings will apply to local, national and international levels.Trial registration numberNCT03564184

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Endoscopic sutured gastroplasty in addition to lifestyle modification: short-term efficacy in a controlled randomised trial

Gut ◽

10.1136/gutjnl-2020-322026 ◽

2020 ◽

pp. gutjnl-2020-322026

Author(s):

Vincent Huberty ◽

Ivo Boskoski ◽

Vincenzo Bove ◽

Pauline Van Ouytsel ◽

Guido Costamagna ◽

...

Keyword(s):

Weight Loss ◽

Lifestyle Modification ◽

Controlled Trial ◽

Randomised Trial ◽

Body Weight Loss ◽

Total Body Weight ◽

Control Group ◽

Short Term ◽

Randomised Controlled

ObjectiveEndoscopic suture gastroplasty (ESG) has been developed as an alternative treatment for moderately obese patients. We present our results of a short-term randomised controlled trial on a new suturing technique, the Endomina system (E-ESG, Endo Tools therapeutics, Belgium).DesignEligible patients (body mass index 30–40 kg/m2) were randomised in a 2:1 ratio to receive lifestyle modification plus E-ESG or lifestyle modification alone (control group); dietetic counselling and follow-up were identical. Endpoints included a mean excess weight loss (EWL) of more than 25% 12 months after E-ESG and a 15% EWL difference at 6 months between groups. At 6 months, a cross-over to E-ESG was offered to the control group. All patients were followed for a total of 12 months after E-ESG.ResultsOf the 71 patients included (five male, mean age 40 years), mean EWL at 6 months was significantly higher in the treatment (38.6%, n=45) than in the control group (13.4%, n=21; p<0.001). At 6 months, satiety tests demonstrated a higher decrease in mean volume (41% vs 2.5%, p<0.001), and mean quality of life (QoL) was also higher in the treatment group (52.8 vs 45.1 p<0.05). No procedure-related or device-related severe adverse events were observed. Twelve months follow-up after E-ESG showed a mean EWL of 45.1%, which translated into a total body weight loss of 11.8%.ConclusionsThis study demonstrates that E-ESG is safe and effective, providing a 25% better EWL at 6 months than lifestyle modification alone. This weight loss was maintained and resulted in a significant improvement in QoL up to 18 months after treatment.Trial registration numberNCT03255005.

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A Randomised Controlled Trial of the Effect of Esmarch Tourniquet Use on Blood Loss, Bruising and Quality of Life in Elective Varicose Vein Surgery

Phlebology The Journal of Venous Disease ◽

10.1177/026835550201700104 ◽

2002 ◽

Vol 17 (1) ◽

pp. 10-12

Author(s):

A. Fowler ◽

M. Stechman ◽

D. Mitchell

Keyword(s):

Quality Of Life ◽

Blood Loss ◽

Varicose Vein ◽

Controlled Trial ◽

Randomised Trial ◽

Varicose Vein Surgery ◽

Clinical Value ◽

Prospective Randomised Trial ◽

Randomised Controlled

Objective: To assess the effect of tourniquet use on bleeding, bruising and quality of life in varicose vein surgery. Method: A prospective randomised trial of 49 patients undergoing varicose vein surgery was carried out. All patients were having single leg surgery as a day case. Blood loss was assessed by weighing swabs. Bruising was measured at 10 days, and quality of life assessed with SF36 questionaires. Synthesis: In the tourniquet group blood loss was significantly reduced but not the area of bruising. The SF36 scores showed deterioration in the non-tourniquet group at 10 days but this was not present at 6 weeks. We saw no complications of tourniquet use but the study was limited by disappointing recruitment reducing the power. Conclusion: Tourniquet use may be of clinical value. A larger study is required to assess the significance.

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Chewing gum to treat postoperative nausea and emesis in female patients (CHEWY): rationale and design for a multicentre randomised trial

BMJ Open ◽

10.1136/bmjopen-2018-027505 ◽

2019 ◽

Vol 9 (6) ◽

pp. e027505

Author(s):

Jai Darvall ◽

Britta Sylvia von Ungern-Sternberg ◽

Sabine Braat ◽

David Story ◽

Andrew Davidson ◽

...

Keyword(s):

General Anaesthesia ◽

Postoperative Nausea ◽

Controlled Trial ◽

Randomised Trial ◽

Ethics Committees ◽

Complete Response ◽

Chewing Gum ◽

Female Patients ◽

Patient Dissatisfaction ◽

Randomised Controlled

IntroductionPostoperative nausea, retching and vomiting (PONV) remains one of the most common side effects of general anaesthesia, contributing significantly to patient dissatisfaction, cost and complications. Chewing gum has potential as a novel, drug-free alternative treatment. We aim to conduct a large, definitive randomised controlled trial of the efficacy and safety of peppermint-flavoured chewing gum to treat PONV in the postanaesthesia care unit (PACU). If chewing gum is shown to be as effective as ondansetron, this trial has the potential to significantly improve outcomes for tens of millions of surgical patients around the world each year.Methods and analysisThis is a prospective, multicentre, randomised controlled non-inferiority trial. 272 female patients aged ≥12 years having volatile anaesthetic-based general anaesthesia for breast or laparoscopic surgery will be randomised. Patients experiencing nausea, retching or vomiting in PACU will be randomised to 15 min of chewing gum or 4 mg intravenous ondansetron. The primary outcome (complete response) is cessation of PONV within 2 hours of administration, with no recurrence nor rescue medication requirement for 2 hours after administration.Ethics and disseminationThe Chewy Trial has been approved by the Human Research Ethics Committees at all sites. Dissemination will be via international and national anaesthesia conferences, and publication in the peer-reviewed literature.Trial registration numberACTRN12618000429257; Pre-results.

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