scholarly journals Achieving Self-Directed Integrated Cancer Aftercare (ASICA) in melanoma: Protocol for a randomised patient-focused pilot trial of delivering the ASICA intervention as a means to earlier detection of recurrent and second primary melanoma

2019 ◽  
Author(s):  
Peter Murchie ◽  
J Masthoff ◽  
FM Walter ◽  
K Rahman ◽  
JL Allan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Data ◽  
Cutaneous Melanoma ◽  
Controlled Trial ◽  
Primary Melanoma ◽  
Trial Registration ◽  
Randomised Controlled ◽  
The Uk ◽  
Self Examination

Abstract Background: Melanoma is common, 15,906 people in the UK were diagnosed with melanoma in 2015 and incidence has increased five-fold in 30 years. Melanoma affects old and young people with poor prognosis once metastatic. UK guidelines recommends people treated for cutaneous melanoma receive extended outpatient hospital follow-up to detect recurrence or new primaries. Such follow-up to the growing population of melanoma survivors is burdensome for both individuals and health services. Follow-up is important since approximately 20% of patients with early-stage melanoma experience a recurrence and 4-8% develop a new primary, the risk of both is highest in the first five years. ASICA (Achieving Self-directed Integrated Cancer Aftercare) is a digital intervention to increase Total-Skin-Self-Examination (TSSE) by people treated for melanoma, with usual follow-up. Methods: We aim to recruit 240 adults with a previous first stage 0-2C primary cutaneous melanoma from secondary care in North-East Scotland and the East of England. Participants will be randomised to receive the ASICA intervention (a tablet based digital intervention to prompt and support TSSE) or control group (treatment as usual). Patient-reported and clinical data will be collected at baseline, including the modified Melanoma Worry Scale (MWS), the Hospital Anxiety and Depression Scale (HADs), the EuroQoL EQ-5D-5L, and questions about TSSE practice, intentions, self-efficacy and planning. Participants will be followed up by postal questionnaire at 3, 6 and 12 months following randomisation along with a 12 month review of clinical data. 12 months following randomisation will be considered the primary timepoint for outcome analyses. Discussion: If the ASICA intervention improves total-skin-self-examination practice in those affected by melanoma, this may lead to improved psychological well-being and earlier detection of recurrent and new primary melanoma. This could impact both patients and NHS resources. This study will determine if a full scale randomised controlled trial can be undertaken in the UK NHS to provide the high-quality evidence needed determine the effectiveness ASICA is a pilot study evaluating the effectiveness of total skin self-examination practice in those affected by melanoma. Trial Registration: Clinical Trials.gov :Trial registration number NCT03328247. Registered 01 November 2017, https://clinicaltrials.gov/ct2/show/NCT03328247?term=ASICA&rank=1. First participant randomised on 25 January 2018. Keywords: Primary care, Melanoma, Cancer, Randomised Controlled Trial, Survivorship, Self-directed care, e-health, ASICA.

scholarly journals Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Meg Wiggins ◽  
Mary Sawtell ◽  
Octavia Wiseman ◽  
Christine McCourt ◽  
Sandra Eldridge ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Antenatal Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Trial Registration ◽  
Secondary Outcome ◽  
The World ◽  
Randomised Controlled

Abstract Background Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. Methods The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a ‘healthy baby’ composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born “healthy” in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional ‘healthy and positive birth’ of the intervention with standard care. Qualitative data will be analysed thematically. Discussion This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. Trial registration Trial registration; ISRCTN, ISRCTN91977441. Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.

scholarly journals An intervention to optimise coach-created motivational climates and reduce athlete willingness to dope (CoachMADE): a three-country cluster randomised controlled trial

2020 ◽  
pp. bjsports-2019-101963
Author(s):  
Nikos Ntoumanis ◽  
Eleanor Quested ◽  
Laurie Patterson ◽  
Stella Kaffe ◽  
Susan H Backhouse ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomised Controlled Trial ◽  
Trial Registration ◽  
Perceived Effectiveness ◽  
Cluster Randomised ◽  
Randomised Controlled

ObjectivesCoach-centred antidoping education is scarce. We tested the efficacy of a motivationally informed antidoping intervention for coaches, with their athletes’ willingness to dope as the primary outcome.MethodsWe delivered a cluster randomised controlled trial in Australia, the UK and Greece. This study was a parallel group, two-condition, superiority trial. Participants were 130 coaches and 919 athletes. Coaches in the intervention group attended two workshops and received supplementary information to support them in adopting a motivationally supportive communication style when discussing doping-related issues with their athletes. Coaches in the control condition attended a standard antidoping workshop that provided up-to-date information on antidoping issues yet excluded any motivation-related content. Assessments of willingness to dope (primary outcome) and other secondary outcomes were taken at baseline, postintervention (3 months) and at a 2-month follow up.ResultsCompared with athletes in the control group, athletes in the intervention group reported greater reductions in willingness to take prohibited substances (effect size g=0.17) and psychological need frustration (g=0.23) at postintervention, and greater increases in antidoping knowledge (g=0.27) at follow-up. Coaches in the intervention group reported at postintervention greater increases in efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours (g=0.45) to deal with doping-related situations. They also reported greater decreases in doping attitudes (g=0.24) and perceived effectiveness of need thwarting behaviours (g=0.35).ConclusionsAntidoping education programmes should consider incorporating principles of motivation, as these could be beneficial to coaches and their athletes. We offer suggestions to strengthen these programmes, as most of the effects we observed were not sustained at follow-up.Trial registration numberThis trial has been registered with the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371465&isReview=true).

scholarly journals 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 ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e025788 ◽  
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.

scholarly journals Early provision of intrauterine contraception as part of abortion care—5-year results of a randomised controlled trial

2020 ◽  
Vol 35 (4) ◽  
pp. 796-804
Author(s):  
Elina Pohjoranta ◽  
Satu Suhonen ◽  
Mika Gissler ◽  
Pirjo Ikonen ◽  
Maarit Mentula ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Trial Registration ◽  
Medical Society ◽  
Control Group ◽  
Abortion Care ◽  
Intrauterine Contraception ◽  
Study Results ◽  
Randomised Controlled

Abstract STUDY QUESTION Can the incidence of subsequent termination of pregnancy (TOP) be reduced by providing intrauterine contraception as part of the abortion service? SUMMARY ANSWER Provision of an intrauterine device (IUD) as part of TOP services reduced the need for subsequent TOP but the effect was limited to the first 3 years of the 5-year follow-up. WHAT IS KNOWN ALREADY An IUD is highly effective in preventing subsequent TOP. Prompt initiation of IUD use leads to a higher usage rate during follow-up, as compliance with post-TOP IUD insertion visits is low. STUDY DESIGN, SIZE, DURATION The objective of this randomised controlled trial was to assess the effect of early comprehensive provision of intrauterine contraception after TOP, with primary outcome being the incidence of subsequent TOP during the 5 years of follow-up after the index abortion. This study was conducted at a tertiary care centre between 18 October 2010 and 21 January 2013. Altogether, 748 women undergoing a first trimester TOP were recruited and randomised into two groups. The intervention group (n = 375) was provided with an IUD during surgical TOP or 1–4 weeks following medical TOP at the hospital providing the abortion care. Women in the control group (n = 373) were advised to contact primary health care for follow-up and IUD insertion. Subsequent TOPs during the 5-year follow-up were identified from the Finnish Register on induced abortions. PARTICIPANTS/MATERIALS, SETTING, METHODS The inclusion criteria were age ≥18 years, duration of gestation ≤12 weeks, residence in Helsinki and accepting intrauterine contraception. Women with contraindications to IUD were excluded. MAIN RESULTS AND THE ROLE OF CHANCE The overall numbers of subsequent TOPs were 50 in the intervention and 72 in the control group (26.7 versus 38.6/1000 years of follow-up, P = 0.027), and those of requested TOPs, including TOPs and early pregnancy failures, were 58 and 76, respectively (30.9 versus 40.8/1000, P = 0.080). Altogether 40 (10.7%) women in the intervention and 63 (16.9%) in the control group underwent one or several subsequent TOPs (hazard ratio 1.67 [95% CI 1.13 to 2.49], P = 0.011). The number of TOPs was reduced by the intervention during years 0–3 (22.2 versus 46.5/1000, P = 0.035), but not during years 4–5 (33.3 versus 26.8/1000, P = 0.631). LIMITATIONS, REASONS FOR CAUTION Both medical and surgical TOP were used. This may be seen as a limitation, but it also reflects the contemporary practice of abortion care. The immediate post-TOP care was provided by two different organizations, allowing us to compare two different ways of contraceptive service provision following TOP. WIDER IMPLICATIONS OF THE FINDINGS Providing TOP and IUD insertion comprehensively in the same heath care unit leads to significantly higher rates of attendance, IUD use and a significantly lower risk of subsequent TOP. STUDY FUNDING/COMPETING INTEREST(S) This study was supported by Helsinki University Central Hospital Research funds and by research grants provided by the Jenny and Antti Wihuri Foundation, the Yrjö Jahnsson Foundation and Finska Läkaresällskapet. E.P. has received a personal research grant from the Finnish Medical Society. The City of Helsinki supported the study by providing the IUDs. The funding organisations had no role in planning or execution of the study, or in analysing the study results. TRIAL REGISTRATION NUMBER The trial was registered at clinicaltrials.gov (NCT01223521). TRIAL REGISTRATION DATE 18 October 2010. DATE OF FIRST PATIENT’S ENROLMENT 18 October 2010.

scholarly journals Evaluating the effectiveness of the smartphone app, Drink Less, compared with the NHS alcohol advice webpage, for the reduction of alcohol consumption among hazardous and harmful adult drinkers in the UK at six-month follow-up: protocol for a randomised controlled trial

2020 ◽  
Author(s):  
Claire Garnett ◽  
Melissa Oldham ◽  
Colin Angus ◽  
Emma Beard ◽  
Robyn Burton ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Alcohol Consumption ◽  
Large Scale ◽  
Controlled Trial ◽  
Economic Evaluations ◽  
Intention To Treat ◽  
Randomised Controlled ◽  
The Uk

AbstractBackground and AimsDigital interventions are effective for reducing alcohol consumption but evidence is limited regarding smartphone apps. Drink Less is a theory- and evidence-informed app to help people reduce their alcohol consumption that has been refined in terms of its content and design for usability across the socio-demographic spectrum. We aim to evaluate the effectiveness and cost-effectiveness of recommending Drink Less at reducing alcohol consumption compared with usual digital care.DesignTwo-arm individually randomised controlled trial.SettingOnline trial in the UK.ParticipantsHazardous or harmful drinkers (Alcohol Use Disorders Identification Test score >=8) aged 18+, and want to drink less alcohol (n=5,562). Participants will be recruited from July 2020 to May 2022 using multiple strategies with a focus on remote digital methods.Intervention and comparatorParticipants will be randomised to receive either an email recommending that they use Drink Less (intervention) or view the NHS webpage on alcohol advice (comparator).MeasurementsThe primary outcome is change in self-reported weekly alcohol consumption between baseline and 6-month follow-up. Secondary outcomes include the proportion of hazardous drinkers; alcohol-related problems and injury; health-related quality of life, and use of health services assessed at 6-month follow-up. Effectiveness will be examined with one-way ANCOVAs, adjusting for baseline alcohol consumption, and using an intention-to-treat approach. A mixed-methods process evaluation will assess engagement, acceptability and mechanism of action. Economic evaluations will be conducted using both a short- and longer-term time horizon.CommentsThis study will establish the effectiveness and cost-effectiveness of the Drink Less app at reducing alcohol consumption among hazardous and harmful adult drinkers and will be the first RCT of an alcohol reduction app for the general population in the UK. This study will inform the decision on whether it is worth investing resources in large-scale implementation.

scholarly journals Long term effects of once-only flexible sigmoidoscopy screening after 17 years of follow-up: the UK Flexible Sigmoidoscopy Screening randomised controlled trial

The Lancet ◽  
2017 ◽  
Vol 389 (10076) ◽  
pp. 1299-1311 ◽  
Author(s):  
Wendy Atkin ◽  
Kate Wooldrage ◽  
D Maxwell Parkin ◽  
Ines Kralj-Hans ◽  
Eilidh MacRae ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Flexible Sigmoidoscopy ◽  
Controlled Trial ◽  
Long Term Effects ◽  
Randomised Controlled ◽  
The Uk
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