Preventing blood-borne virus infection in people who inject drugs in the UK: systematic review, stakeholder interviews, psychosocial intervention development and feasibility randomised controlled trial

Background Opioid substitution therapy and needle exchanges have reduced blood-borne viruses (BBVs) among people who inject drugs (PWID). Some PWID continue to share injecting equipment. Objectives To develop an evidence-based psychosocial intervention to reduce BBV risk behaviours and increase transmission knowledge among PWID, and conduct a feasibility trial among PWID comparing the intervention with a control. Design A pragmatic, two-armed randomised controlled, open feasibility trial. Service users were Steering Group members and co-developed the intervention. Peer educators co-delivered the intervention in London. Setting NHS or third-sector drug treatment or needle exchanges in Glasgow, London, Wrexham and York, recruiting January and February 2016. Participants Current PWID, aged ≥ 18 years. Interventions A remote, web-based computer randomisation system allocated participants to a three-session, manualised, psychosocial, gender-specific group intervention delivered by trained facilitators and BBV transmission information booklet plus treatment as usual (TAU) (intervention), or information booklet plus TAU (control). Main outcome measures Recruitment, retention and follow-up rates measured feasibility. Feedback questionnaires, focus groups with participants who attended at least one intervention session and facilitators assessed the intervention’s acceptability. Results A systematic review of what works to reduce BBV risk behaviours among PWID; in-depth interviews with PWID; and stakeholder and expert consultation informed the intervention. Sessions covered improving injecting technique and good vein care; planning for risky situations; and understanding BBV transmission. Fifty-six per cent (99/176) of eligible PWID were randomised: 52 to the intervention group and 47 to the control group. Only 24% (8/34) of male and 11% (2/18) of female participants attended all three intervention sessions. Overall, 50% (17/34) of men and 33% (6/18) of women randomised to the intervention group and 47% (14/30) of men and 53% (9/17) of women randomised to the control group were followed up 1 month post intervention. Variations were reported by location. The intervention was acceptable to both participants and facilitators. At 1 month post intervention, no increase in injecting in ‘risky’ sites (e.g. groin, neck) was reported by participants who attended at least one session. PWID who attended at least one session showed a trend towards greater reduction in injecting risk behaviours, a greater increase in withdrawal planning and were more confident about finding a vein. A mean cost of £58.17 per participant was calculated for those attending one session, £148.54 for those attending two sessions and £270.67 for those attending all three sessions, compared with £0.86 in the control group. Treatment costs across the centres vary as a result of the different levels of attendance, as total session costs are divided by attendees to obtain a cost per attendee. The economic analysis suggests that a cost-effectiveness study would be feasible given the response rates and completeness of data. However, we have identified aspects where the service use questionnaire could be abbreviated given the low numbers reported in several care domains. No adverse events were reported. Conclusions As only 19% of participants attended all three intervention sessions and 47% were followed up 1 month post intervention, a future definitive randomised controlled trial of the intervention is not feasible. Exposure to information on improving injecting techniques did not encourage riskier injecting practices or injecting frequency, and benefits were reported among attendees. The intervention has the potential to positively influence BBV prevention. Harm reduction services should ensure that the intervention content is routinely delivered to PWID to improve vein care and prevent BBVs. Future work The intervention did not meet the complex needs of some PWID, more tailoring may be needed to reach PWID who are more frequent injectors, who are homeless and female. Limitations Intervention delivery proved more feasible in London than other locations. Non-attendance at the York trial site substantially influenced the results. Trial registration Current Controlled Trials ISRCTN66453696 and PROSPERO 014:CRD42014012969. Funding This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 72. See the NIHR Journals Library website for further project information.

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A randomised feasibility trial of an employer-based intervention for enhancing successful return to work of cancer survivors (MiLES intervention)

BMC Public Health ◽

10.1186/s12889-021-11357-9 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

M. A. Greidanus ◽

A. E. de Rijk ◽

A. G. E. M. de Boer ◽

M. E. M. M. Bos ◽

P. W. Plaisier ◽

...

Keyword(s):

Return To Work ◽

Cancer Survivors ◽

Controlled Trial ◽

Intervention Group ◽

Work Outcomes ◽

Feasibility Trial ◽

Control Group ◽

Secondary Effect ◽

Quality Of Working Life ◽

Randomised Controlled

Abstract Background Employers express a need for support during sickness absence and return to work (RTW) of cancer survivors. Therefore, a web-based intervention (MiLES) targeted at employers with the objective of enhancing cancer survivors’ successful RTW has been developed. This study aimed to assess feasibility of a future definitive randomised controlled trial (RCT) on the effectiveness of the MiLES intervention. Also preliminary results on the effectiveness of the MiLES intervention were obtained. Methods A randomised feasibility trial of 6 months was undertaken with cancer survivors aged 18–63 years, diagnosed with cancer < 2 years earlier, currently in paid employment, and sick-listed < 1 year. Participants were randomised to an intervention group, with their employer receiving the MiLES intervention, or to a waiting-list control group (2:1). Feasibility of a future definitive RCT was determined on the basis of predefined criteria related to method and protocol-related uncertainties (e.g. reach, retention, appropriateness). The primary effect measure (i.e. successful RTW) and secondary effect measures (e.g. quality of working life) were assessed at baseline and 3 and 6 months thereafter. Results Thirty-five cancer survivors were included via medical specialists (4% of the initially invited group) and open invitations, and thereafter randomised to the intervention (n = 24) or control group (n = 11). Most participants were female (97%) with breast cancer (80%) and a permanent employment contract (94%). All predefined criteria for feasibility of a future definitive RCT were achieved, except that concerning the study’s reach (90 participants). After 6 months, 92% of the intervention group and 100% of the control group returned to work (RR: 0.92, 95% CI: 0.81–1.03); no difference were found with regard to secondary effect measures. Conclusions With the current design a future definitive RCT on the effectiveness of the MiLES intervention on successful RTW of cancer survivors is not feasible, since recruitment of survivors fell short of the predefined minimum for feasibility. There was selection bias towards survivors at low risk of adverse work outcomes, which reduced generalisability of the outcomes. An alternative study design is needed to study effectiveness of the MiLES intervention. Trial registration The study has been registered in the Dutch Trial Register (NL6758/NTR7627).

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Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial

Health Technology Assessment ◽

10.3310/hta21340 ◽

2017 ◽

Vol 21 (34) ◽

pp. 1-92 ◽

Cited By ~ 8

Author(s):

William Jeffcoate ◽

Frances Game ◽

Vivienne Turtle-Savage ◽

Alison Musgrove ◽

Patricia Price ◽

...

Keyword(s):

Diabetes Mellitus ◽

Usual Care ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Health Technology ◽

Control Group ◽

Advisory Panel ◽

Health Economic Analysis ◽

Randomised Controlled

Background Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel. Objective To assess both the clinical effectiveness and the cost-effectiveness of lightweight fibreglass casts in the management of heel ulcers. Design A pragmatic, multicentre, parallel, observer-blinded randomised controlled trial. A central randomisation centre used a computer-generated random number sequence to allocate participants to groups. Setting Thirty-five specialist diabetic foot secondary care centres in the UK. Those recruited were aged ≥ 18 years and had diabetes mellitus complicated by ulcers of the heel of grades 2–4 on the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel scale. Participants In total, 509 participants [68% male, 15% with type 1 diabetes mellitus, mean age 67.5 years (standard deviation 12.4 years)] were randomised 1 : 1 to the intervention (n = 256) or the control (n = 253) arm. The primary outcome data were available for 425 participants (212 from the intervention arm and 213 from the control arm) and exceeded the total required; attrition was 16.5%. The median ulcer area at baseline was 275 mm2 [interquartile range (IQR) 104–683 mm2] in the intervention group and 206 mm2 (IQR 77–649 mm2) in the control group. There were no differences between the two groups at baseline in any parameter, neither in relation to the participant nor in relation to their ulcer. Interventions The intervention group received usual care supplemented by the addition of an individually moulded, lightweight, fibreglass heel cast. The control group received usual care alone. The intervention phase continued either until the participant’s ulcer had healed (maintained for 28 days) or for 24 weeks, whichever occurred first. During this intervention phase, the participants were reviewed every 2 weeks, and the fibreglass casts were replaced when they were no longer usable. Main outcome measures The primary outcome measure was ulcer healing (confirmed by a blinded observer and maintained for 4 weeks) within 24 weeks. Other outcome measures included the time taken for the ulcer to heal, the percentage reduction in the cross-sectional area, the reduction in local pain, amputation, survival and health economic analysis. The study was powered to define a difference in healing of 15% (55% intervention vs. 40% control). Results Forty-four per cent (n = 94) of the intervention group healed within 24 weeks, compared with 37% (n = 80) of the control participants (odds ratio 1.42, 95% confidence interval 0.95 to 2.14; p = 0.088), using an intention-to-treat analysis. No differences were observed between the two groups for any secondary outcome. Limitations Although the component items of care were standardised, because this was a pragmatic trial, usual care was not uniform. There was some evidence of a small excess of adverse events in the intervention group; however, non-blinded observers documented these events. There was no excess of adverse device effects. Conclusions There may be a small increase in healing with the use of a heel cast, but the estimate was not sufficiently precise to provide strong evidence of an effect. There was no evidence of any subgroup in which the intervention appeared to be particularly effective. A health economic analysis suggested that it is unlikely that the intervention represents good value for money. The provision of a lightweight heel cast may be of benefit to some individuals, but we have found no evidence to justify the routine adoption of this in clinical practice. Future work It is unlikely that further study of this intervention will have an impact on usual clinical care, and so future efforts should be directed towards other interventions designed to improve the healing of ulcers in this population. Trial registration Current Controlled Trials ISRCTN62524796. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 34. See the NIHR Journals Library website for further project information.

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Effectiveness of a mindfulness-oriented substance use prevention program for boys with mild to borderline intellectual disabilities: study protocol for a randomised controlled trial

BMC Public Health ◽

10.1186/s12889-020-09878-w ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Lucie Waedel ◽

Anne Daubmann ◽

Antonia Zapf ◽

Olaf Reis

Keyword(s):

Substance Use ◽

Randomised Controlled Trial ◽

Intellectual Disabilities ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Post Intervention ◽

Randomised Controlled

Abstract Background Boys with mild to borderline intellectual disabilities (MBID) are at particular risk to drink in harmful ways once they start to consume alcohol. Interventions based on mindfulness have been proven to be effective in preventing substance use, but mostly for adults with MBID. A mindfulness oriented intervention targeting 11–17 years old boys will be tested in a randomised controlled trial. Study aim is to investigate the benefits of this new intervention compared to an active control condition within a 12 months follow-up. Methods In this randomised controlled proof of concept study, 82 boys with MBID who consumed any alcohol during the last year will be randomised either to the 6 week mindfulness oriented intervention or the control group receiving a control intervention equal in dose and length. The intervention group undergoes mindfulness training combined with interactive drug education, while the control group completes a health training combined with the same education. In the intention-to-treat analysis the primary outcome is the self-reported delay of first post-intervention drunkeness within a 12 months follow-up time span, measured weekly with a short app-based questionnaire. Secondary outcome is the use of alcohol, tobacco and other drugs within 30 days post-intervention. Changes in neurobiological behavioural parameters, such as impulse control, reward anticipation, and decision making, are also investigated. Other secondary outcomes regard trait mindfulness, emotion regulation, psychopathological symptoms, peer networks, perceived stress, and quality of life. In addition, a prospective registry will be established to record specific data on the population of 11–17 year old boys with MBID without any alcohol experience. Discussion This study offers the opportunity to gain first evidence of the effectiveness of a mindfulness-oriented program for the prevention of substance use for boys with MBID. Trial registration German Clinical Trials Register, DRKS00014042. Registered on March 19th 2018.

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Effects of the Conceptual Model of Health Literacy as a Risk: A Randomised Controlled Trial in a Clinical Dental Context

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph15081630 ◽

2018 ◽

Vol 15 (8) ◽

pp. 1630 ◽

Cited By ~ 4

Author(s):

Linda Stein ◽

Maud Bergdahl ◽

Kjell Sverre Pettersen ◽

Jan Bergdahl

Keyword(s):

Health Literacy ◽

Conceptual Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Convenience Sample ◽

Communication Techniques ◽

The Mean ◽

Randomised Controlled

Numerous conceptual models of health literacy have been proposed in the literature, but very few have been empirically validated in clinical contexts. The aim of this study was to test the effects of the conceptual model of health literacy as a risk in a clinical dental context. A convenience sample of 133 Norwegian-speaking adults was recruited. Participants were randomly allocated to an intervention group (n = 64, 54% women, mean age = 50 years) and a control group (n = 69, 49% women, mean age = 46 years). Clinical measurements were conducted pre-intervention and six months post-intervention. In the intervention group, communication regarding patients’ oral health was tailored to their health literacy levels using recommended communication techniques, whereas the control group received brief information not tailored to health literacy levels. The ANCOVA showed significant between-group effects, finding reduced post-intervention mean gingival (p < 0.000) and mean plaque (p < 0.000) indices in the intervention group when controlling for baseline index scores. The adjusted Cohen’s d indicated large effect sizes between the intervention group and the control group for both the mean gingival index (−0.98) and the mean plaque index (−1.33). In conclusion, the conceptual model of health literacy as a risk had a large effect on important clinical outcomes, such as gingival status and oral hygiene. The model may be regarded as a suitable supplement to patient education in populations.

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Study protocol for the ‘HelpMeDoIt!’ randomised controlled feasibility trial: an app, web and social support-based weight loss intervention for adults with obesity

BMJ Open ◽

10.1136/bmjopen-2017-017159 ◽

2017 ◽

Vol 7 (10) ◽

pp. e017159 ◽

Cited By ~ 11

Author(s):

Lynsay Matthews ◽

Juliana Pugmire ◽

Laurence Moore ◽

Mark Kelson ◽

Alex McConnachie ◽

...

Keyword(s):

Social Support ◽

Weight Loss ◽

Controlled Trial ◽

Qualitative Interviews ◽

Intervention Group ◽

Ethics Committee ◽

Feasibility Trial ◽

Control Group ◽

Weight Loss Intervention ◽

Randomised Controlled

IntroductionHelpMeDoIt! will test the feasibility of an innovative weight loss intervention using a smartphone app and website. Goal setting, self-monitoring and social support are three key facilitators of behaviour change. HelpMeDoIt! incorporates these features and encourages participants to invite ‘helpers’ from their social circle to help them achieve their goal(s).AimTo test the feasibility of the intervention in supporting adults with obesity to achieve weight loss goals.Methods and analysis12-month feasibility randomised controlled trial and accompanying process evaluation. Participants (n=120) will be adults interested in losing weight, body mass index (BMI)>30 kg/m2and smartphone users. The intervention group will use the app/website for 12 months. Participants will nominate one or more helpers to support them. Helpers have access to the app/website. The control group will receive a leaflet on healthy lifestyle and will have access to HelpMeDoIt! after follow-up. The key outcome of the study is whether prespecified progression criteria have been met in order to progress to a larger randomised controlled effectiveness trial. Data will be collected at baseline, 6 and 12 months. Outcomes focus on exploring the feasibility of delivering the intervention and include: (i) assessing three primary outcomes (BMI, physical activity and diet); (ii) secondary outcomes of waist/hip circumference, health-related quality of life, social support, self-efficacy, motivation and mental health; (iii) recruitment and retention; (iv) National Health Service (NHS) resource use and participant borne costs; (v) usability and acceptability of the app/website; and (vi) qualitative interviews with up to 50 participants and 20 helpers on their experiences of the intervention. Statistical analyses will focus on feasibility outcomes and provide initial estimates of intervention effects. Thematic analysis of qualitative interviews will assess implementation, acceptability, mechanisms of effect and contextual factors influencing the intervention.Ethics and disseminationThe protocol has been approved by the West of Scotland NHS Research Ethics Committee (Ref: 15/WS/0288) and the University of Glasgow MVLS College Ethics Committee (Ref: 200140108). Findings will be disseminated widely through peer-reviewed publication and conference presentations.Trial registration numberISRCTN85615983.

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Evaluating the effectiveness of a ‘real-world’ shared reading intervention for preschool children and their families: A randomised controlled trial.

10.31234/osf.io/habg9 ◽

2018 ◽

Author(s):

Jamie Lingwood ◽

Josie Billington ◽

Caroline F Rowland

Keyword(s):

Randomised Controlled Trial ◽

Reading Interventions ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Shared Reading ◽

Control Group ◽

Post Intervention ◽

Reading Groups ◽

Randomised Controlled

Background: Shared reading interventions can impact positively on preschool children’s language development and on their caregiver’s attitudes/behaviours towards reading. However, a number of barriers may discourage families from engaging with these interventions, particularly families from lower socioeconomic (SES) backgrounds. We investigated how families from such backgrounds responded to an intervention designed explicitly to overcome these barriers. Methods: In a pre-registered cluster randomised controlled trial, 85 lower SES families and their 3- to 4-year old children from 10 different preschools were randomly allocated to take part in The Reader’s Shared Reading programme (intervention) or an existing ‘Story Time’ group at a library (control), once a week for eight weeks. Three outcome measures were assessed at baseline and post-intervention: (i) attendance, (ii) enjoyment of the reading groups, and (iii) caregivers’ knowledge of, attitudes and behaviours towards reading. A fourth, - children’s vocabulary - was assessed at baseline and four weeks post-intervention. Results: Families were significantly more likely to attend the intervention group and rated them more favourably, compared to the control group. However, there were no significant effects on caregivers’ knowledge, attitudes and behaviours, or on children’s language. Conclusion: The intervention was only successful in engaging families from disadvantaged backgrounds in shared reading. Implications for the use, duration and intensity of shared reading interventions are discussed.

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Medication reconciliation knowledge among hospital pharmacists in Nigeria: A non-randomised controlled trial

Pharmacy Education ◽

10.46542/pe.2021.211.528537 ◽

2021 ◽

pp. 528-537

Author(s):

Akinniyi A. Aje ◽

Segun J. Showande ◽

Titilayo O. Fakeye

Keyword(s):

Randomised Controlled Trial ◽

Educational Intervention ◽

Medication Reconciliation ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

College Hospital ◽

Tertiary Hospitals ◽

Randomised Controlled

Background: Medication reconciliation (MR) is a patient-centred evolving role of pharmacists that improves patient’s health outcomes. Aim: To assess the effect of an educational intervention on pharmacists’ MR knowledge in two Nigerian tertiary hospitals. Methods: A two-arm parallel non-randomised controlled trial was carried out at two tertiary hospitals in Nigeria, one as intervention and the other as control site. Pharmacists’ MR knowledge was assessed pre-intervention and at one-, three- and six-month post-intervention. The intervention consisted of seminar and role-plays. Data were summarised with descriptive and inferential statistics. Results: A total of 75 pharmacists completed the study. Scores for pre-intervention out of a total of 38 was 19.31±4.76 in the intervention group and 17.50±6.86 in the control group. Post-intervention assessment scores (University College Hospital vs University of Ilorin Teaching Hospital) at one, three and six months were 29.82±5.01 vs 25.97±5.31, 31.53±4.99 vs 26.10±5.20, and 31.69±4.10 vs 23.07±3.98, respectively (p < 0.01). Conclusion: The educational intervention led to improved pharmacists’ MR knowledge.

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A multicentre, pragmatic, cluster randomised, controlled feasibility trial of the POD system of care

Age and Ageing ◽

10.1093/ageing/afaa044 ◽

2020 ◽

Vol 49 (4) ◽

pp. 640-647

Author(s):

John Young ◽

John Green ◽

Amanda Farrin ◽

Michelle Collinson ◽

Suzanne Hartley ◽

...

Keyword(s):

Controlled Trial ◽

Intervention Group ◽

Group Versus ◽

Assessment Method ◽

System Of Care ◽

Feasibility Trial ◽

Control Group ◽

Cluster Randomised ◽

Randomised Controlled ◽

New Onset

Abstract Objective to provide a preliminary estimate of the effectiveness of the prevention of delirium (POD) system of care in reducing incident delirium in acute hospital wards and gather data for a future definitive randomised controlled trial. Design cluster randomised and controlled feasibility trial. Setting sixteen acute care of older people and orthopaedic trauma wards in eight hospitals in England and Wales. Participants patients 65 years and over admitted to participating wards during the trial period. Interventions participating wards were randomly assigned to either the POD programme or usual care, determined by existing local policies and practices. The POD programme is a manualised multicomponent delirium prevention intervention that targets 10 risk factors for delirium. The intervention wards underwent a 6-month implementation period before trial recruitment commenced. Main outcome measure incidence of new-onset delirium measured using the Confusion Assessment Method (CAM) measured daily for up to 10 days post consent. Results out of 4449, 3274 patients admitted to the wards were eligible. In total, 714 patients consented (713 registered) to the trial, thirty-three participants (4.6%) withdrew. Adherence to the intervention was classified as at least medium for seven wards. Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37–1.26); P = 0.2225). Conclusions based on these findings, a definitive trial is achievable and would need to recruit 5220 patients in 26 two-ward hospital clusters. Trial registration: ISRCTN01187372. Registered 13 March 2014.

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Tailored digital behaviour change intervention with e-referral system to increase attendance at NHS stop smoking services (the MyWay project): study protocol for a randomised controlled feasibility trial

BMJ Open ◽

10.1136/bmjopen-2018-028721 ◽

2019 ◽

Vol 9 (4) ◽

pp. e028721

Author(s):

Emily Fulton ◽

Katie Newby ◽

Kajal Gokal ◽

Kayleigh Kwah ◽

Lauren Schumacher ◽

...

Keyword(s):

Behaviour Change ◽

Service Management ◽

Controlled Trial ◽

Intervention Group ◽

Feasibility Trial ◽

Control Group ◽

Behaviour Change Intervention ◽

Stop Smoking ◽

Stop Smoking Services ◽

Randomised Controlled

IntroductionIn the UK, smokers who use stop smoking services (SSSs) are four times more likely to stop smoking than smokers who do not. Attendance has declined, warranting the development of interventions to address this. StopApp is a novel, brief online behaviour change intervention designed to address common barriers to SSS attendance. It links to widely commissioned service management software that enables instant appointment booking at a user’s location and time of choice.Methods and analysisA two-arm parallel group, individual participant feasibility randomised controlled trial of StopApp (intervention) compared with the standard promotion of and referral to SSSs (control). The study includes a nested qualitative process evaluation to assess the acceptability of the research processes, with a subsample of participants. Smokers aged over 16 years will be recruited via three routes: General Practice (GP), community settings and online. After consenting and the collection of baseline data, participants will be randomised to control or intervention groups. Participants in the intervention group receive a link to StopApp and those in the control group receive standard web-based information about the SSSs. All participants are told they can book a SSS appointment but are under no obligation to do so. Online follow-up 2 months post randomisation includes data on SSS use and carbon monoxide verified 4-week quit rates. The study aims to recruit 162 smokers.Ethics and disseminationEthics approval has been granted by the West Midlands—Edgbaston NHS Research Ethics Committee. The findings will be reported in conferences and peer-reviewed publications; and will be used to design the parameters necessary for a definitive trial to ascertain the effectiveness of StopApp at increasing booking and attendance at SSSs compared with existing methods for encouraging uptake.

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Evaluation of an Ultrasound-Guided Palpation Intervention for Palpation Skill Training: A Single-Blind, Parallel Group, Randomised Controlled Trial

10.21203/rs.3.rs-832314/v1 ◽

2021 ◽

Author(s):

Takashi Kitagawa ◽

Yuma Aoki ◽

Hotaka Sugimoto ◽

Natsumi Ozaki

Keyword(s):

Medical Students ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Post Intervention ◽

Parallel Group ◽

Randomised Controlled ◽

Single Blind

Abstract Although there are increasing reports on the usefulness of sonopalpation with ultrasound imaging, many previous studies have reported interventions without a control group. This single-blind, parallel group randomised controlled trial aimed to determine whether educational instruction with sonopalpation for medical students has a superior effect on skill improvement than traditional instruction without ultrasonography. Twenty-nine medical students participated in the study and were randomised using block randomisation into an ultrasound imaging group (n = 15) and a control group (n = 14). Then, they underwent three training sessions focusing on the shoulder joint. Participants underwent a scoring assessment of their palpation skills at pre-intervention, post-intervention, and follow-up 3 months after training. The raters were blinded to the subjects’ group. The Friedman and Mann–Whitney U tests were used for data analysis. The intervention group showed a significant increase in scores at post-intervention and at the 3-month follow-up when compared with the pre-intervention group (p < 0.05); the effect sizes were large (0.849 and 0.849, respectively). A comparison of the scores at different time points after the intervention at the 3-month follow-up revealed that there was no significant difference between the groups. Education using ultrasound images may improve the sonopalpation skills of medical students.

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