Artificial intelligence and colonoscopy experience: lessons from two randomised trials

Background and aimsArtificial intelligence has been shown to increase adenoma detection rate (ADR) as the main surrogate outcome parameter of colonoscopy quality. To which extent this effect may be related to physician experience is not known. We performed a randomised trial with colonoscopists in their qualification period (AID-2) and compared these data with a previously published randomised trial in expert endoscopists (AID-1).MethodsIn this prospective, randomised controlled non-inferiority trial (AID-2), 10 non-expert endoscopists (<2000 colonoscopies) performed screening/surveillance/diagnostic colonoscopies in consecutive 40–80 year-old subjects using high-definition colonoscopy with or without a real-time deep-learning computer-aided detection (CADe) (GI Genius, Medtronic). The primary outcome was ADR in both groups with histology of resected lesions as reference. In a post-hoc analysis, data from this randomised controlled trial (RCT) were compared with data from the previous AID-1 RCT involving six experienced endoscopists in an otherwise similar setting.ResultsIn 660 patients (62.3±10 years; men/women: 330/330) with equal distribution of study parameters, overall ADR was higher in the CADe than in the control group (53.3% vs 44.5%; relative risk (RR): 1.22; 95% CI: 1.04 to 1.40; p<0.01 for non-inferiority and p=0.02 for superiority). Similar increases were seen in adenoma numbers per colonoscopy and in small and distal lesions. No differences were observed with regards to detection of non-neoplastic lesions. When pooling these data with those from the AID-1 study, use of CADe (RR 1.29; 95% CI: 1.16 to 1.42) and colonoscopy indication, but not the level of examiner experience (RR 1.02; 95% CI: 0.89 to 1.16) were associated with ADR differences in a multivariate analysis.ConclusionsIn less experienced examiners, CADe assistance during colonoscopy increased ADR and a number of related polyp parameters as compared with the control group. Experience appears to play a minor role as determining factor for ADR.Trial registration numberNCT:04260321.

Download Full-text

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.

Download Full-text

A Comparison of Acupuncture with Advice and Exercises on the Symptomatic Treatment of Osteoarthritis of the Hip – a Randomised Controlled Trial

Acupuncture in Medicine ◽

10.1136/aim.19.1.19 ◽

2001 ◽

Vol 19 (1) ◽

pp. 19-26 ◽

Cited By ~ 35

Author(s):

Roisin Haslam

Keyword(s):

Controlled Trial ◽

Randomised Trial ◽

Symptomatic Treatment ◽

Post Treatment ◽

Control Group ◽

Group A ◽

Pre Treatment ◽

Group B ◽

Randomised Controlled

Acupuncture is becoming a common technique within the physiotherapy profession as a treatment modality for pain relief; however, few randomised controlled trials have been undertaken to assess the effectiveness of acupuncture, particularly in the treatment of osteoarthritis (OA) of the hip. Therefore, a randomised trial to compare the effectiveness of acupuncture with advice and exercises on the symptomatic treatment of OA of the hip was carried out. Thirty-two patients awaiting a total hip arthroplasty were randomly allocated to either the experimental group, (A), to have six sessions of acupuncture each lasting up to 25 minutes, or the control group, (B), to be given advice and exercises for their hip over a six week period. Group A consisted of three men and 13 women, and group B consisted of four men and eight women. The average age in group A was 66 years and in group B it was 68 years. Patients were assessed for pain and functional ability, using a modified version of the WOMAC questionnaire, pre-treatment, immediately post-treatment and at eight weeks post-treatment. The pre-treatment WOMAC scores in the two groups were similar (p=0.85). There was a significant improvement in group A (decrease in WOMAC score) immediately post-treatment (p=0.002) and this was maintained at the eight-week follow-up (p=0.03). There were no significant changes in group B. When the changes in WOMAC scores were compared between groups, a significantly greater improvement was found between pre-treatment and immediately post-treatment in group A, compared with group B (p=0.02). The changes between pre-treatment and the eight-week follow-up also showed a significant improvement in group A compared with group B (p=0.03). In conclusion, this trial supports the hypothesis that acupuncture is more effective than advice and exercises in the symptomatic treatment of OA of the hip.

Download Full-text

Pain Squad+ smartphone app to support real-time pain treatment for adolescents with cancer: protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-037251 ◽

2020 ◽

Vol 10 (3) ◽

pp. e037251

Author(s):

Lindsay Jibb ◽

Paul C Nathan ◽

Vicky Breakey ◽

Conrad Fernandez ◽

Donna Johnston ◽

...

Keyword(s):

Real Time ◽

Pain Treatment ◽

Controlled Trial ◽

Qualitative Interviews ◽

Randomised Trial ◽

Control Group ◽

Management Support ◽

Scientific Meetings ◽

Randomised Controlled ◽

The Impact

IntroductionPain negatively affects the health-related quality of life (HRQL) of adolescents with cancer. The Pain Squad+ smartphone-based application (app), has been developed to provide adolescents with real-time pain self-management support. The app uses a validated pain assessment and personalised pain treatment advice with centralised decision support via a registered nurse to enable real-time pain treatment in all settings. The algorithm informing pain treatment advice is evidence-based and expert-vetted. This trial will longitudinally evaluate the impact of Pain Squad+, with or without the addition of nurse support, on adolescent health and cost outcomes.Methods and analysisThis will be a pragmatic, multicentre, waitlist controlled, 3-arm parallel-group superiority randomised trial with 1:1:1 allocation enrolling 74 adolescents with cancer per arm from nine cancer centres. Participants will be 12 to 18 years, English-speaking and with ≥3/10 pain. Exclusion criteria are significant comorbidities, end-of-life status or enrolment in a concurrent pain study. The primary aim is to determine the effect of Pain Squad+, with and without nurse support, on pain intensity in adolescents with cancer, when compared with a waitlist control group. The secondary aims are to determine the immediate and sustained effect over time of using Pain Squad+, with and without nurse support, as per prospective outcome measurements of pain interference, HRQL, pain self-efficacy and cost. Linear mixed models with baseline scores as a covariate will be used. Qualitative interviews with adolescents from all trial arms will be conducted and analysed.Ethics and disseminationThis trial is approved by the Hospital for Sick Children Research Ethics Board. Results will provide data to guide adolescents with cancer and healthcare teams in treating pain. Dissemination will occur through partnerships with stakeholder groups, scientific meetings, publications, mass media releases and consumer detailing.Trial registration numberNCT03632343(ClinicalTrials.gov).

Download Full-text

IMPROV-ED trial: eHealth programme for faster recovery and reduced healthcare utilisation after CABG

Netherlands Heart Journal ◽

10.1007/s12471-020-01508-9 ◽

2020 ◽

Author(s):

G. J. van Steenbergen ◽

D. van Veghel ◽

J. ter Woorst ◽

D. van Lieshout ◽

L. Dekker

Keyword(s):

Quality Of Life ◽

Patient Satisfaction ◽

Controlled Trial ◽

Artery Bypass ◽

Randomised Trial ◽

Intervention Group ◽

Healthcare Utilisation ◽

Control Group ◽

Randomised Controlled

Abstract Background After coronary artery bypass grafting (CABG), healthcare utilisation is high and is partly unplanned. eHealth applications have been proposed to reduce healthcare consumption and to enable patients to get actively involved in their recovery. This way, healthcare expenses can be reduced and the quality of care can be improved. Objectives We aim to evaluate whether the use of an eHealth programme can reduce unplanned healthcare utilisation and improve mental and physical health in the first 6 weeks after discharge in patients who underwent CABG. In addition, patient satisfaction and use of the eHealth programme will be evaluated. Methods For this single-centre randomised controlled trial, at least 280 patients referred for CABG will be included at the preoperative outpatient clinic and randomised to an intervention or control group. The intervention group will have access to an eHealth programme, which consists of online educational videos developed by the Dutch Heart Foundation and postoperative video consultations with a physician. The control group will receive standard care and will not have access to the eHealth programme. The primary endpoint is healthcare utilisation; other endpoints include anxiety, duration of recovery, quality of life and patient satisfaction. Participants will complete several questionnaires at 6 time points during the study. Results Patient enrolment started in February 2020 and completion of the follow-up period is expected in August 2021. Conclusion This randomised trial was initiated to test the hypothesis that patients who are partaking in our eHealth programme use less unplanned care and experience a better quality of life, less anxiety and a faster recovery than controls.

Download Full-text

Worksite intervention study to prevent diabetes in Nepal: a randomised trial protocol

Open Heart ◽

10.1136/openhrt-2019-001236 ◽

2020 ◽

Vol 7 (2) ◽

pp. e001236

Author(s):

Prajjwal Pyakurel ◽

Archana Shrestha ◽

Biraj M Karmacharya ◽

Shyam S Budhathoki ◽

Rajendra Kumar Chaudhari ◽

...

Keyword(s):

Controlled Trial ◽

Control Period ◽

Randomised Trial ◽

Intervention Group ◽

T Test ◽

Control Group ◽

Behavioural Intervention ◽

Haemoglobin A1c ◽

Full Time ◽

Randomised Controlled

IntroductionIn Nepal, approximately 31% of adult industrial employees have diabetes. While the prevention of type 2 diabetes through behavioural intervention has been disseminated, worksite could be an effective platform for the translation of this knowledge into action as employed adults spend most of their workday waking hours at workplaces.Methods and analysisWe will conduct a randomised controlled trial to assess the effectiveness of a behavioural and a canteen intervention on diabetes risk reduction among those who are prediabetic at two worksites in eastern Nepal. We will recruit 162 adult full-time factory workers with haemoglobin A1c (HbA1c) of 5.7%–6.4% at baseline or fasting blood sugar of 100–125 mg/dL. The 8–14 months’ control period will be followed by the behavioural intervention where half of the participants will be randomised to receive the behavioural intervention and half will act as a control and will not receive any intervention. Then, all participants will receive the canteen intervention. The analysis will be intent-to-treat, comparing the difference in the change in HbA1c% between the behavioural intervention group and the control group using a two-sample t-test. The within-participant changes in HbA1c after 6 or more months on the canteen intervention among those not randomised to the behavioural intervention in the previous period will be assessed using the paired t-test.Ethics and disseminationEthical approval was obtained from the Institutional Review Board at Yale School of Public Health, New Havens, USA and the Nepal Health Research Council.Trial registration numberNCT04161937.

Download Full-text

An α-lactalbumin-enriched and symbiotic-supplemented v. a standard infant formula: a multicentre, double-blind, randomised trial

British Journal Of Nutrition ◽

10.1017/s000711451100479x ◽

2011 ◽

Vol 107 (11) ◽

pp. 1616-1622 ◽

Cited By ~ 25

Author(s):

Jean-Christophe Rozé ◽

Sébastien Barbarot ◽

Marie-José Butel ◽

Nathalie Kapel ◽

Anne-Judith Waligora-Dupriet ◽

...

Keyword(s):

Atopic Dermatitis ◽

Infant Formula ◽

Controlled Trial ◽

Randomised Trial ◽

Secretory Iga ◽

Control Group ◽

Double Blind ◽

Randomised Controlled ◽

Similar Growth ◽

Experimental Group

The aim of the present study was to evaluate the safety, tolerance and preventive effect on atopic dermatitis of an experimental α-lactalbumin-enriched and symbiotic-supplemented infant formula. A total of ninety-seven non-breastfed term neonates were enrolled into a double-blind, multicentre, randomised controlled trial in which they received experimental (n 48) or standard formula (n 49) for 6 months. The primary outcome was weight at 6 months of age. Secondary outcomes were gastrointestinal tolerance and manifestation of atopic dermatitis. Faecal secretory IgA (SIgA) concentration and microbiota composition of forty-three infants were analysed at 1 and 6 months. Growth was similar in both groups. At 1 month, compared to those in the control group, infants in the experimental group exhibited less crying or agitation, and more quiet behaviour (P = 0·03). At 6 months, atopic dermatitis was less frequently observed in the experimental group (P < 0·05). Decrease of faecal SIgA concentration between 1 and 6 months was mainly observed in the control group. This decrease was significantly associated with atopic dermatitis (P < 0·014) and negatively correlated to the level of colonisation by bifidobacteria (P < 0·005). In conclusion, compared to the control formula, the experimental formula guaranteed a similar growth, was better tolerated at 1 month and had a protective effect against the development of atopic dermatitis.

Download Full-text

Video-observed therapy and medication adherence for tuberculosis patients: randomised controlled trial in Moldova

European Respiratory Journal ◽

10.1183/13993003.00493-2020 ◽

2020 ◽

Vol 56 (2) ◽

pp. 2000493 ◽

Cited By ~ 1

Author(s):

Luke Ravenscroft ◽

Stewart Kettle ◽

Ruth Persian ◽

Simon Ruda ◽

Lilian Severin ◽

...

Keyword(s):

Medication Adherence ◽

Controlled Trial ◽

Treatment Success ◽

Randomised Trial ◽

Multidrug Resistant ◽

Control Group ◽

Directly Observed Therapy ◽

Middle Income ◽

Satisfaction With Treatment ◽

Randomised Controlled

IntroductionThe effectiveness of video-observed therapy (VOT) for treating tuberculosis (TB) has not been measured in low- and middle-income countries (LMICs), where >95% of TB cases and deaths occur. In this study, we analyse the effectiveness and patient cost-difference of VOT compared to clinic-based directly observed therapy (DOT) in improving medication adherence in Moldova, a LMIC in Eastern Europe.MethodsThe study was a two-arm individually randomised trial with 197 TB patients (n=99 DOT control group; n=98 VOT treatment group; multidrug-resistant TB cases were excluded). The primary outcome was observed medication adherence, measured by the number of days that a patient failed to be observed adhering to medication for every 2-week period during the course of their treatment.ResultsVOT significantly decreased nonadherence by 4 days (95% CI 3.35–4.67 days, p<0.01) per 2-week period: 5.24 days missed per 2-week period for DOT and 1.29 days for VOT. VOT patients spent MDL 504 (∼EUR 25) (95% CI MDL 277–730, p<0.01) and 58 h (95% CI 48–68 h, p<0.01) less on their treatment. In addition, VOT increased self-reported satisfaction with treatment. We found no significant results pertaining to treatment success, patient wellbeing or patient employment status and some evidence of an increase in side-effects.DiscussionIn this trial, VOT increased observed medication adherence for TB patients in Moldova, a LMIC, when compared to clinic-based DOT. Additionally, VOT significantly reduced the time and money patients spent on their treatment.

Download Full-text

Prevention of child mental health problems through parenting interventions in Southeastern Europe (RISE): study protocol for a multi-site randomised controlled trial

Trials ◽

10.1186/s13063-021-05817-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Diana Tăut ◽

Adriana Băban ◽

Inga Frantz ◽

Ingrid Dănilă ◽

Jamie M. Lachman ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Mental Health Problems ◽

Controlled Trial ◽

Randomised Trial ◽

Parent Report ◽

Behavioural Problems ◽

Control Group ◽

Link Type ◽

Randomised Controlled

Abstract Background Childhood adversities, such as poor parental practices, exposure to violence, and risk behaviours strongly impact children’s future mental and behavioural problems. Adversities affect families living in disadvantaged environments and low- and middle-income countries (LMICs) to a greater extent than in high-income countries. Parenting programmes are an effective way to alleviate them, although their outreach and scalability is still limited in LMICs. Methods/design A multi-site randomised controlled trial will be conducted in North Macedonia, Republic of Moldova and Romania to test the efficacy and cost-effectiveness of an optimised version of the promising Parenting for Lifelong Health Programme for Young Children (PLH-YC, 5 sessions), against a standard lecture on parenting issues (control group, 1 session). At least 864 participants who report having children between 2 and 9 years old who display elevated levels of behavioural difficulties will be randomised on a 1:1 basis to the intervention and control groups. The primary outcome will consist of parent report of child oppositional aggressive behaviour. Post-test (four months) and follow-up (12 months) assessments will provide information on short- and longer-term effects of PLH-YC compared to the parenting lecture in the control group. Discussion This randomised trial will test the efficacy of PLH-YC in alleviating child behavioural problems and assess the cost-effectiveness, transportability across three different cultural contexts, and potential for scalability of the programme. Trial registration ClinicalTrials.gov., Registration number: NCT04721730 (https://clinicaltrials.gov/ct2/show/NCT04721730). Registered 13.01.2021

Download Full-text

Effectiveness of Child to Parent Communication Using Information Package on Food Hygiene

International Journal of Innovative Research in Medical Science ◽

10.23958/ijirms/vol03-i07/02 ◽

2018 ◽

Vol 3 (07) ◽

Author(s):

Ms. Sonam Yangchen Bhutia ◽

Dr. Sushma Kumari Saini ◽

Dr. Manmeet Kaur ◽

Dr. Sandhya Ghai

Keyword(s):

School Children ◽

Home Visit ◽

Controlled Trial ◽

Family Members ◽

Sampling Technique ◽

Control Group ◽

Food Hygiene ◽

Parent Communication ◽

Post Test ◽

Randomised Controlled

School children can act as change agent not only for families but for community. The study aimed to assess effectiveness of information package on knowledge and practices of parents/family members of school children studying in Govt. Sr. Sec. School on food hygiene in Dhanas and Daddu Majra Colony, UT, Chandigarh. A non-randomised controlled trial was conducted on 201 school children studying in VIIth standard and their parents/family members. Purposive sampling technique was utilised to enrol 101 in case and 100 participants in control group. Interview schedule for knowledge assessment and observation checklist for assessing the practices of parents/ family members was used. Pre assessment of both the groups was done by a home visit. Experimental group school children were educated on food hygiene as per the protocol. Pre and post-test knowledge of school children on food hygiene was assessed and were asked to disseminate the information to their parents/family members. After 15 days, second time home visit was done to the parents/family members of both the groups for the post assessment of knowledge and practices. Significant improvement in knowledge and practices of parents/family members related to food hygiene was observed. Hence, school children can be an effective tool in health related knowledge dissemination which can further promote healthy practices.

Download Full-text

Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol

Human Reproduction Open ◽

10.1093/hropen/hoab001 ◽

2021 ◽

Vol 2021 (1) ◽

Author(s):

S van Wessel ◽

T Hamerlynck ◽

V Schutyser ◽

C Tomassetti ◽

C Wyns ◽

...

Keyword(s):

Live Birth ◽

Financial Support ◽

Controlled Trial ◽

Reproductive Age ◽

Fertility Treatment ◽

Control Group ◽

Women Of Reproductive Age ◽

Operative Hysteroscopy ◽

Randomised Controlled

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

Download Full-text