Virtual outpatient clinic as an alternative to an actual clinic visit after surgical discharge: a randomised controlled trial

BackgroundIt is standard practice to review all patients following discharge at a follow-up clinic but demands on all health services outweigh resources and unnecessary review appointments may delay or deny access to patients with greater needs.AimsThis randomised trial aimed to establish whether a virtual outpatient clinic (VOPC) was an acceptable alternative to an actual outpatient clinic (OPC) attendance for a broad range of general surgical patients following a hospital admission.Patients and methodsAll patients admitted under one general surgical service over the study period were assessed. If eligible for inclusion the rationale, randomisation and follow-up methods were explained, consent was sought and patients randomised to receive either a VOPC or an OPC appointment.ResultsTwo-hundred and nine patients consented to study inclusion, of which 98/107 (91.6%) in the VOPC group and 83/102 (81.4%) in the OPC group were successfully contacted. Only 6 patients in the OPC group and 10 in the VOPC group reported ongoing issues. A further follow-up indicated 78 of 82 (95%) VOPC patients were very happy with their overall experience compared with 34/61 (56%) in the actual OPC group (p<0.001). A significant proportion of both cohorts—68/82 (83%) in VOPC group and 41/61 (67%) in OPC group (p = 0.029)—preferred a VOPC appointment as their future follow-up of choice.ConclusionsThe majority of patients discharged from a surgical service could be better followed up by a virtual clinic with a significant proportion of patients reporting a preference for and a greater satisfaction with such a service.

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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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DHA supplementation in infants born preterm and the effect on attention at 18 months’ corrected age: follow-up of a subset of the N3RO randomised controlled trial

British Journal Of Nutrition ◽

10.1017/s0007114520002500 ◽

2020 ◽

pp. 1-12 ◽

Cited By ~ 2

Author(s):

Erandi Hewawasam ◽

Carmel T. Collins ◽

Beverly S. Muhlhausler ◽

Lisa N. Yelland ◽

Lisa G. Smithers ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

High Dose ◽

Peak Period ◽

Soya Oil ◽

Randomised Controlled ◽

To Receive ◽

The Brain

Abstract Infants born preterm miss out on the peak period of in utero DHA accretion to the brain during the last trimester of pregnancy which is hypothesised to contribute to the increased prevalence of neurodevelopmental deficits in this population. This study aimed to determine whether DHA supplementation in infants born preterm improves attention at 18 months’ corrected age. This is a follow-up of a subset of infants who participated in the N3RO randomised controlled trial. Infants were randomised to receive an enteral emulsion of high-dose DHA (60 mg/kg per d) or no DHA (soya oil – control) from within the first days of birth until 36 weeks’ post-menstrual age. The assessment of attention involved three tasks requiring the child to maintain attention on toy/s in either the presence or absence of competition or a distractor. The primary outcome was the child’s latency of distractibility when attention was focused on a toy. The primary outcome was available for seventy-three of the 120 infants that were eligible to participate. There was no evidence of a difference between groups in the latency of distractibility (adjusted mean difference: 0·08 s, 95 % CI –0·81, 0·97; P = 0·86). Enteral DHA supplementation did not result in improved attention in infants born preterm at 18 months’ corrected age.

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Experiences of patients and physiotherapists with blended internet-based vestibular rehabilitation: a qualitative interview study

BJGP Open ◽

10.3399/bjgpopen20x101092 ◽

2020 ◽

Vol 4 (5) ◽

pp. bjgpopen20X101092

Author(s):

Vincent A van Vugt ◽

Anja JThCM de Kruif ◽

Johannes C van der Wouden ◽

Henriëtte E van der Horst ◽

Otto R Maarsingh

Keyword(s):

Controlled Trial ◽

Randomised Trial ◽

Qualitative Interview ◽

Vestibular Rehabilitation ◽

Interview Study ◽

Structured Interviews ◽

Qualitative Interview Study ◽

Vestibular Symptoms ◽

Randomised Controlled

BackgroundInternet-based vestibular rehabilitation (VR) with physiotherapy support, known as blended VR, was effective in reducing vestibular symptoms in a recent randomised controlled trial. Blended VR is a complex intervention comprised of physiotherapeutic visits, the vertigo training website, and VR exercises. Because of these interacting components, it is important to understand how blended VR works, for whom it works best, and how it should ideally be delivered.AimTo investigate the experiences of both patients and physiotherapists with blended internet-based VR.Design & settingA qualitative interview study was performed with patients who received blended internet-based VR with physiotherapy support, and physiotherapists who provided this support.MethodSemi-structured interviews were conducted with 14 patients and eight physiotherapists after the 6-month follow-up of the randomised trial. All interviews were audio-recorded, transcribed, and thematically analysed.ResultsAccording to both patients and physiotherapists, the physiotherapist visits were useful in providing personal attention, helping patients safely execute exercises, and improving patients’ adherence to therapy. Some patients said they did not need physiotherapist support and, according to physiotherapists, both the necessity and the optimal way to deliver guidance differed greatly between patients. The Vertigo Training website and exercises provided patients with a sense of control over their symptoms. Patients reported that the VR exercises were easy to perform and most patients continued to use them long after the trial ended.ConclusionIn blended VR, physiotherapeutic visits appear to offer benefits above the vertigo training website and VR exercises alone. Physiotherapy support may best be used when individually tailored.

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Adherence therapy for people with schizophrenia

The British Journal of Psychiatry ◽

10.1192/bjp.bp.105.019489 ◽

2006 ◽

Vol 189 (6) ◽

pp. 508-514 ◽

Cited By ~ 108

Author(s):

Richard Gray ◽

Morven Leese ◽

Jonathan Bindman ◽

Thomas Becker ◽

Lorenzo Burti ◽

...

Keyword(s):

Quality Of Life ◽

Health Education ◽

Controlled Trial ◽

Clinical Settings ◽

Clinical Instability ◽

Randomised Controlled ◽

To Receive ◽

Adherence Therapy

BackgroundThere is equivocal evidence of the effectiveness of adherence therapy in improving treatment adherence and clinical outcomes for people with schizophrenia.AimsTo evaluate the effectiveness of adherence therapy in improving quality of life for people with schizophrenia.MethodA 52-week, single-blind, multicentre randomised controlled trial of the effectiveness of adherence therapy. Participants were individually randomised to receive eight sessions of adherence therapy or health education. Assessments were undertaken at baseline and at 52-week follow-up.ResultsAdherence therapy was no more effective than health education in improving quality of life.ConclusionsThis effectiveness trial provides evidence for the lack of effect of adherence therapy in people with schizophrenia with recent clinical instability, treated in ordinary clinical settings.

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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.

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Individualised screening for diabetic retinopathy: the ISDR study—rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening

BMJ Open ◽

10.1136/bmjopen-2018-025788 ◽

2019 ◽

Vol 9 (6) ◽

pp. e025788 ◽

Cited By ~ 9

Author(s):

Deborah M Broadbent ◽

Christopher J Sampson ◽

Amu Wang ◽

Lola Howard ◽

Abigail E Williams ◽

...

Keyword(s):

Diabetic Retinopathy ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Screening Programme ◽

Controlled Trial ◽

Randomised Trial ◽

Variable Interval ◽

Randomised Controlled ◽

The Uk

IntroductionCurrently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually. Resources are not increasing despite a 5% increase in the numbers of PWD nationwide each year. We describe the rationale, design and methodology for a randomised controlled trial (RCT) evaluating the safety, acceptability and cost-effectiveness of personalised variable-interval risk-based screening for DR. This is the first randomised trial of personalised screening for DR and the largest ophthalmic RCT in the UK.Methods and analysisPWD attending seven screening clinics in the Liverpool Diabetic Eye Screening Programme were recruited into a single site RCT with a 1:1 allocation to individualised risk-based variable-interval or annual screening intervals. A risk calculation engine developed for the trial estimates the probability that an individual will develop referable disease (screen positive DR) within the next 6, 12 or 24 months using demographic, retinopathy and systemic risk factor data from primary care and screening programme records. Dynamic, secure, real-time data connections have been developed. The primary outcome is attendance for follow-up screening. We will test for equivalence in attendance rates between the two arms. Secondary outcomes are rates and severity of DR, visual outcomes, cost-effectiveness and health-related quality of life. The required sample size was 4460 PWD. Recruitment is complete, and the trial is in follow-up.Ethics and disseminationEthical approval was obtained from National Research Ethics Service Committee North West – Preston, reference 14/NW/0034. Results will be presented at international meetings and published in peer-reviewed journals. This pragmatic RCT will inform screening policy in the UK and elsewhere.Trial registration numberISRCTN87561257; Pre-results.

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Naltrexone implants after in-patient treatment for opioid dependence: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.108.055319 ◽

2009 ◽

Vol 194 (6) ◽

pp. 541-546 ◽

Cited By ~ 48

Author(s):

Nikolaj Kun⊘e ◽

Philipp Lobmaier ◽

John Kåre Vederhus ◽

Bj⊘rg Hjerkinn ◽

Solfrid Hegstad ◽

...

Keyword(s):

Opioid Dependence ◽

Controlled Trial ◽

Opiate Dependence ◽

Patient Treatment ◽

Opioid Use ◽

Heroin Use ◽

Naltrexone Treatment ◽

Randomised Controlled ◽

To Receive

BackgroundNaltrexone has considerable potential in helping to prevent relapse in heroin dependency. A longer-lasting formulation for naltrexone treatment is desirable to further reduce non-adherence and relapse during treatment of opiate dependence.AimsTo evaluate the safety and effectiveness of a 6-month naltrexone implant in reducing opioid use after in-patient treatment.MethodA group of 56 abstinence-oriented patients who completed in-patient treatment for opioid dependence were randomly and openly assigned to receive either a 6-month naltrexone implant or their usual aftercare. Drug use and other outcomes were assessed at 6-month follow-up.ResultsPatients receiving naltrexone had on average 45 days less heroin use and 60 days less opioid use than controls in the 180-day period (both P<0.05). Blood tests showed naltrexone levels above 1 ng/ml for the duration of 6 months. Two patients died, neither of whom had received an implant.ConclusionsNaltrexone implant treatment safely and significantly reduces opioid use in a motivated population of patients.

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Can Patient-Led Surveillance Detect Subsequent New Primary or Recurrent Melanomas and Reduce the Need for Routinely Scheduled Follow Up? A Protocol for the MEL-SELF Randomised Controlled Trial.

10.21203/rs.3.rs-264883/v1 ◽

2021 ◽

Author(s):

Deonna Ackermann ◽

Amelia K Smit ◽

Monika Janda ◽

Cathelijne van Kemenade ◽

Mbathio Dieng ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Clinicopathological Characteristics ◽

Clinic Visit ◽

Usual Practice ◽

Technical Performance ◽

Keratinocyte Cancer ◽

Randomised Controlled ◽

Clinic Visits

Abstract Background: Most subsequent new primary or recurrent melanomas might be self-detected if patients are trained to systematically self-examine their skin and have access to timely medical review (patient-led surveillance). Routinely scheduled clinic visits (clinician-led surveillance) is resource-intensive and has not been shown to improve health outcomes; fewer visits may be possible if patient-led surveillance is shown to be safe and effective. The MEL-SELF trial is a randomised controlled trial comparing patient-led surveillance with clinician-led surveillance in people who have been previously treated for localised melanoma. Methods: Stage 0/I/II melanoma patients (n=600) from dermatology, surgical, or general practice clinics in NSW Australia, will be randomised (1:1) to the intervention (patient-led surveillance, n=300) or control (usual care, n=300). Patients in the intervention will undergo a second randomisation 1:1 to polarised (n=150) or non-polarised (n=150) dermatoscope. Patient-led surveillance comprises an educational booklet, skin self-examination (SSE) instructional videos; 3-monthly email/SMS reminders to perform SSE; patient-performed dermoscopy with teledermatologist feedback; clinical review of positive teledermoscopy through fast-tracked unscheduled clinic visits; and routinely scheduled clinic visits following each clinician’s usual practice. Clinician-led surveillance comprises an educational booklet and routinely scheduled clinic visits following each clinician’s usual practice. The primary outcome, measured at 12-months, is the proportion of participants diagnosed with a subsequent new primary or recurrent melanoma diagnosed at an unscheduled clinic visit. Secondary outcomes include time from randomisation to diagnosis (of a subsequent new primary or recurrent melanoma and of a new keratinocyte cancer), clinicopathological characteristics of subsequent new primary or recurrent melanomas (including AJCC stage), psychological outcomes, and healthcare use. A nested qualitative study will include interviews with patients and clinicians, and a costing study we will compare costs from a societal perspective. We will compare the technical performance of two different models of dermatoscope (polarised vs non-polarised).Discussion: The findings from this study may inform guidance on evidence-based follow up care, that maximises early detection of subsequent new primary or recurrent melanoma and patient wellbeing, while minimising costs to patients, health systems, and society.Trial registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000176864. Registered 18 February 2021, https://www.anzctr.org.au/ACTRN12621000176864.aspx

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Long-term effectiveness of antiseptic cream for recurrent epistaxis in childhood: five-year follow up of a randomised, controlled trial

The Journal of Laryngology & Otology ◽

10.1017/s0022215107001600 ◽

2008 ◽

Vol 122 (10) ◽

pp. 1084-1087 ◽

Cited By ~ 9

Author(s):

S Robertson ◽

H Kubba

Keyword(s):

Controlled Trial ◽

Clinic Visit ◽

Term Outcome ◽

Case Record ◽

Long Term Outcome ◽

Recurrent Epistaxis ◽

Randomised Controlled ◽

Record Review

AbstractObjectives:To determine the long-term outcome for children treated for recurrent epistaxis, and to compare the efficacy of antiseptic cream treatment and nasal cautery.Study design and participants:Retrospective analytical cohort study of 88 children treated for recurrent epistaxis in 2001.Methods:Five-year data on chlorhexidine–neomycin cream usage, nasal cautery, current epistaxis frequency and emergency room attendance was collected by telephone interview and case record review.Results:During their first clinic visit, 51 per cent of the children had been treated with cautery and cream and 35 per cent with cream alone; 14 per cent had received no treatment. Five years later, 65 per cent of these children were still having ongoing epistaxis. Those who had undergone cautery and received cream had the highest ongoing bleeding rate (77 per cent).Conclusion:The majority of children treated at our clinic for recurrent epistaxis had ongoing bleeding five years later. Despite the proven short-term efficacy of chlorhexidine–neomycin cream, few patients receive further courses of cream or are referred back to the clinic.

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Can postal prompts from general practitioners improve the uptake of breast screening? A randomised controlled trial in one east London general practice

Journal of Medical Screening ◽

10.1136/jms.5.1.49 ◽

1998 ◽

Vol 5 (1) ◽

pp. 49-52 ◽

Cited By ~ 9

Author(s):

A M O'Connor ◽

C J Griffiths ◽

M R Underwood ◽

S Eldridge

Keyword(s):

General Practitioner ◽

Breast Screening ◽

Controlled Trial ◽

Randomised Trial ◽

Randomised Control Trial ◽

Inner Cities ◽

Personal Recommendation ◽

Randomised Controlled ◽

To Receive ◽

The City

Objective To determine the effect on the uptake of breast screening of a personalised letter from the general practitioner recommending mammography, sent to coincide with an invitation from the NHS breast screening programme. Design Randomised control trial with stratification of prognostic variables. Setting A group practice in Hackney, east London. Subjects 473 women invited for breast screening by the City and East London Breast Screening Service. Outcome measureAttendance for mammography. Results All women in the randomised trial were followed up; 134 of 236 (57%) randomly allocated to receive the prompting letter attended for mammography compared with 120 of 234 (51%) controls. This difference was not significant (χ2 =1.43, p=0.23) Conclusion Personal recommendation by a letter prompting attendance for mammography from the general practitioner known best to women due to be screened did not improve uptake of breast screening in this east London practice. Other strategies are needed to increase uptake of mammography in inner cities.

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