Quasi-randomised Controlled Trial Research Articles

Effect of One-on-one Structured Counselling of Mothers and Family Members Using GALPAC Technique Compared to Standard Counselling on Post-discharge Kangaroo Mother Care and Related Outcomes in Low-birth-weight Infants: A Quasi-randomised Controlled Trial

Background and Objectives Kangaroo mother care (KMC) improves low-birth-weight neonatal survival. It is recommended for low-birth-weight babies in all settings and should be continued at home as well. Counselling of mothers and family members is necessary for successful initiation and continuation of KMC. This study aims to use the greet, ask, listen, praise, advise, check understanding (GALPAC) method of counselling to improve the outcome of home-based KMC. Methods This quasi-randomised controlled trial was done in 266 stable low-birth-weight neonates born in the hospital. In the intervention group, GALPAC counselling was done by trained nurses and paediatricians during the hospital stay, through telephone after discharge and by local ASHA during home visits. The control group received routine counselling during discharge and on follow-up visits by the treating paediatrician. Both groups were examined on the 15th, 30th and 60th day post-discharge for weight changes and were monitored for morbidity, mortality, breastfeeding and continuation of KMC. Results The neonates were divided randomly in two groups: 132 in the intervention group and 134 in the control group. The basic demographic parameters were comparable in both the groups. On the 15th day of follow-up, breastfeeding rate was 86% in the intervention group and 80% in the control group, morbidity was 13.4% and 15.7%, KMC continuation was 84% and 71.3% and re-admission rate was 6.1% and 7.04%, respectively. By the 60th day, the breastfeeding rate was 67.6% and 55.05%, morbidity 3.8% and 19.1%, KMC continuation 65% and 47% and re-admission rate 1.8% and 20.2% in the intervention and control groups, respectively. Mortality was 11.2% in the control group and 1.8% in the intervention group by the 60th day. Weight gain was more in the intervention group than in the control group (1,055.30 ± 122.46 g and 745.77 ± 99.34 g) by day 60. Interpretation and Conclusion The outcome of KMC in the intervention group was better in comparison to the control group for all parameters studied. Therefore, one-on-one structured counselling with regular communication and follow-up is an effective intervention to improve maintenance of KMC at home.

Effect of non-invasive brain stimulation in children with acquired brain injury-a scoping review.

Children and young people (CYP) with acquired brain injury (ABI) require early and effective neurorehabilitation to improve long-term functional outcomes. Non-invasive brain stimulation (NIBS), including transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), have been used to improve motor and sensory skills for children with cerebral palsy. However, there is limited evidence supporting its use in CYP with ABI. To systematically review the TMS and tDCS intervention effects on motor, sensory and other functional issues in CYP with ABI as reported in the literature. A comprehensive online bibliographic databases search was performed in various databases using keywords related to NIBS and CYP with ABI. Studies that examine the effect of NIBS intervention on motor function and other functional difficulties either as a primary or secondary objective were included in this review. Fourteen studies (10 single case reports, one retrospective analysis, one case series, one randomised and one quasi-randomised controlled trial) published between 2006 and 2023 were identified. These studies examined the use of NIBS to manage motor disorders, hearing, vision, headaches, speech and language and memory issues. Seventy-six children with mild to severe ABI had received NIBS. The session frequency (3-20), duration (10-45 min) was variable, and NIBS delivered between 3 and 28 days. The literature describing NIBS interventions in CYP with ABI is scarce. An insufficient number of studies, inadequate information reported in them, and small sample sizes limit the ability to conclude how effective NIBS is in improving motor function and other functional issues in this cohort. Further studies are therefore necessary to examine the therapeutic effects of NIBS to manage various functional problems in the CYP with ABI.

Effects of real-time remote cardiac rehabilitation on exercise capacity and quality of life: a quasi-randomised controlled trial

BackgroundThe impact of real-time remote cardiac rehabilitation (CR) on health and disability-related outcomes and its correlation with physical function are unknown. We compared the effectiveness of real-time remote CR with that of hospital-based CR on physical function improvement and physical functions of improvement (Δ) to clarify the relationship between health and disability at baseline.MethodsPatients with cardiovascular diseases (CVDs) were enrolled (n = 38) in this quasi-randomised controlled trial and underwent 4 weeks of hospital-based CR, followed by 12 weeks of remote or hospital-based CR based on quasi-randomised allocation. Patients were assessed at baseline and after 12 weeks of remote or hospital-based CR using the shortened version of the World Health Organization (WHO) Quality of Life scale (WHOQOL-BREF) for subjective satisfaction, WHO Disability Assessment Schedule (WHODAS2.0-J) for objective performance, and cardiopulmonary exercise test for physical function and peak oxygen uptake (peak VO2). The trends in measured variables from baseline to the post-CR stage were analysed.ResultsSixteen patients (mean age, 72.2 ± 10.4 years) completed remote CR, and 15 patients (mean age, 77.3 ± 4.8 years) completed hospital-based CR. The post-CR physical function differed significantly between the groups (Δpeak VO2, 2.8 ± 3.0 versus 0.84 ± 1.8 mL·min−1·kg−1; p < 0.05). The differences in post-CR changes in the WHOQOL-BREF scores between the groups were insignificant. The post-CR changes in the WHODAS2.0-J scores were significantly lower in the remote CR group than in the hospital-based CR group (ΔWHODAS2.0-J score, –8.56 ± 14.2 versus 2.14 ± 7.6; p < 0.01). Forward multiple stepwise regression analysis using overall data showed that the intervention method (β = 0.339, p < 0.05), baseline cognition (β = − 0.424, p < 0.05), and social interaction level (β = 0.658, p < 0.01; WHODAS2.0-J) were significant independent contributors to Δpeak VO2 (r2 = 0.48, F = 8.13, p < 0.01).ConclusionsRemote CR considerably improved physical function and objective performance in patients with CVDs. Remote CR can be used to effectively treat stable patients who cannot visit hospitals.Trial registrationThis interventional trial was registered at the UMIN-CTR registry (trial title: Development of remote programme for cardiac rehabilitation using wearable electrocardiograph; trial ID: UMIN000041746; trial URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046564; registration date: 2020/09/09).

Effect of a family-involvement combined aerobic and resistance exercise protocol on cancer-related fatigue in patients with breast cancer during postoperative chemotherapy: study protocol for a quasi-randomised controlled trial

IntroductionCancer-related fatigue (CRF) is one of the most common and debilitating side effects experienced by patients with breast cancer (BC) during postoperative chemotherapy. Family-involvement combined aerobic and resistance exercise has...

Effect of real-time remote-based cardiac rehabilitation on subjective satisfaction and objective performance during the coronavirus disease 2019 pandemic

Abstract Background Real-time remote-based cardiac rehabilitation (CR) programmes improve exercise capacity. However, satisfaction and performance improvements after remote-based CR remain unclear. In addition to physical function, subjective satisfaction and objective performance may be adversely affected during the coronavirus disease 2019 pandemic. Purpose This study aimed to compare the effectiveness of real-time remote-based CR versus hospital-based CR in improving physical function, subjective satisfaction, and objective performance (i.e., activity limitations and participation restrictions). Methods We conducted a quasi-randomised controlled trial and recruited 38 patients with cardiovascular disease (CVD). The patients participated in 4 weeks of hospital-based CR, followed by 12 weeks of remote or hospital-based CR based on quasi-randomised allocation. We assessed the participants at baseline and after 12 weeks of remote or hospital-based CR using the shortened version of the World Health Organization Quality of Life scale (WHOQOL-BREF) for subjective satisfaction, the World Health Organization Disability Assessment Schedule (WHODAS 2.0) for objective performance, and peak oxygen uptake (peak VO2) using the cardiopulmonary exercise test, for physical function. We evaluated individual results by measuring baseline to post-CR changes (i.e., delta [Δ]) (paired t-test) and then compared the remote and hospital-based CR programmes (unpaired t-test). Results Sixteen patients (72.2±10.4 years) completed remote-based CR and fifteen patients (77.3±4.8 years) completed hospital-based CR. Seven patients were excluded owing to other health complications (n=2) and inability to attend hospital based-CR (n=5). In the remote-based CR group, the peak VO2 (before: 12.0±2.7 mL min–1 kg–1; after: 14.9±3.9 mL min–1 kg–1; p&amp;lt;0.05) and the WHOQOL-BREF score (before: 77.4±12.8 points; after: 93.9±12.9 points; p&amp;lt;0.001) were significantly higher, whereas the WHODAS 2.0 score was significantly lower (before: 19.9±13.2 points; after: 11.3±6.8 points; p&amp;lt;0.05) after rehabilitation than at baseline. The post-CR physical function differed significantly between the two groups (Δpeak VO2, remote: 2.8±3.0 mL min–1 kg–1; hospital: 0.84±1.8 mL min–1 kg–1; p&amp;lt;0.05). The post-CR change in the WHOQOL-BREF score was not significantly different between the groups. The post-CR change in the WHODAS 2.0 score was significantly lower in the remote-based CR group than in the hospital-based CR group. (ΔWHODAS 2.0 score, remote: –8.56±14.2 points; hospital: 2.14±7.6 points; p&amp;lt;0.01). Conclusions Remote-based CR significantly improved physical function and objective performance in patients with CVD. Remote-based CR could be an effective treatment for stable patients who are unable to visit the hospital during the coronavirus disease 2019 pandemic. In the future, risk stratification according to severity of illness is needed. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Sanei Medicis company.

The Role of Osteopathic Care in Gynaecology and Obstetrics: An Updated Systematic Review.

Background: Many efforts are made to find safer and more feasible therapeutic strategies to improve gynaecological care. Non-pharmacological treatments, such as osteopathic interventions, could be used as complementary strategies to better manage different gynaecological conditions. This review aims to report the effectiveness of osteopathic treatment in the gynaecology and obstetrics field, updating the previous review published in 2016. The secondary aim was to elucidate the role of somatic dysfunction (SD) in osteopathic assessment and treatment procedures, as well as their health and economic implications. Methods: An electronic search was conducted in the following databases: Embase, MEDLINE (PubMed), and Science direct. All types of clinical studies published between May 2014 and December 2021 have been included: randomised controlled trial (RCT), controlled before/after, interrupted time series quasi RCT, case controls, case reports, case series, observational, clinical studies involving any type of osteopathic treatment, (standardised, semi-standardised or patients’ need-based treatment) performed alone or in combination with other treatments, were included). Results: A total of 76,750 were identified through database searching and other sources. After the removal of duplicates, 47,655 papers were screened based on title and abstract. A total of 131 full-text articles were consequently assessed for eligibility. Twenty-one new articles were included in the synthesis. A total of 2632 participants with a mean age of 28.9 ± 10.5 years were included in the review. Conclusions: Results showed an effectiveness of osteopathic care in gynaecology and obstetrics, but the studies were too heterogeneous to perform quantitative analysis and make clinical recommendations. Nevertheless, osteopathic care could be considered a safe complementary approach to traditional gynaecological care.

Effectiveness of interventions for improving livelihood outcomes for people with disabilities in low- and middle-income countries: A systematic review.

People with disabilities-more than a billion people worldwide-are frequently excluded from livelihood opportunities, including employment, social protection, and access to finance. Interventions are therefore needed to improve livelihood outcomes for people with disabilities, such as improving access to financial capital (e.g., social protection), human capital (e.g., health and education/training), social capital (e.g., support) or physical capital (e.g., accessible buildings). However, evidence is lacking as to which approaches should be promoted. This review examines whether interventions for people with disabilities result in improved livelihood outcomes in low- and middle-income countries (LMIC): acquisition of skills for the workplace, access to the job market, employment in formal and informal sectors, income and earnings from work, access to financial services such as grants and loans, and/or access to social protection programmes. The search, up to date as of February 2020, comprised of: (1)an electronic search of databases (MEDLINE, Embase, PsychINFO, CAB Global Health, ERIC, PubMED and CINAHL),(2)screening of all included studies in the instances where reviews were identified,(3)screening reference lists and citations of identified recent papers and reviews, and(4)An electronic search of a range of organisational websites and databases (including ILO, R4D, UNESCO and WHO) using the keyword search for unpublished grey to ensure maximum coverage of unpublished literature, and reduce the potential for publication bias. We included all studies which reported on impact evaluations of interventions to improve livelihood outcomes for people with disabilities in LMIC. We used review management software EPPI Reviewer to screen the search results. A total of 10 studies were identified as meeting the inclusion criteria. We searched for errata for our included publications and found none. Two review authors independently extracted the data from each study report, including for the confidence in study findings appraisal. Data and information were extracted regarding available characteristics of participants, intervention characteristics and control conditions, research design, sample size, risk of bias and outcomes, and results. We found that it was not possible to conduct a meta-analysis, and generate pooled results or compare effect sizes, given the diversity of designs, methodologies, measures, and rigour across studies in this area. As such, we presented out findings narratively. Only one of the nine interventions targeted children with disabilities alone, and only two included a mix of age groups (children and adults with disabilities. Most of the interventions targeted adults with disabilities only. Most single impairment group interventions targeted people with physical impairments alone. The research designs of the studies included one randomised controlled trial, one quasi-randomised controlled trial (a randomised, posttest only study using propensity score matching (PSM), one case-control study with PSM, four uncontrolled before and after studies, and three posttest only studies. Our confidence in the overall findings is low to medium on the basis of our appraisal of the studies. Two studies scored medium using our assessment tool, with the remaining eight scoring low on one or more item. All the included studies reported positive impacts on livelihoods outcomes. However, outcomes varied substantially by study, as did the methods used to establish intervention impact, and the quality and reporting of findings. The findings of this review suggest that it may be possible for a variety of programming approaches to improve livelihood outcomes of people with disabilities in LMIC. However, given low confidence in study findings related to methodological limitations in all the included studies, positive findings must be interpreted with caution. Additional rigorous evaluations of livelihoods interventions for people with disabilities in LMIC are needed.

Evaluation of an individualized, tablet-based physiotherapy training programme for patients with Parkinson’s disease: the ParkProTrain study, a quasi-randomised controlled trial

BackgroundRegular physical activity is of great relevance in Parkinson's disease (PD). It is part of the inpatient multimodal Parkinson's complex treatment (MKP) in Germany. However, there is often a lack of human resources in outpatient settings to continue an interprofessional approach. A large proportion of PD patients live a predominantly sedentary lifestyle and do not get enough exercise.MethodsThe intervention group (IG) used a tablet-based physiotherapy training programme at home for a period of nine months. We conducted a quasi-randomised longitudinal study with three measurement times (at the beginning (t0) and end of MKP (t1) and at 9 months after MKP (t2)). The primary outcome measured was PD-specific quality of life using the PDQ-8. The secondary outcome focused on participation restrictions, falling anxiety, sleep disorder, anxiety and depression as well as comorbidity, pain, performance capability and physical activity.ResultsFor n = 93 IG and n = 137 control group (CG) patients, evaluable cases were available for all measurement times. Both groups achieved significant improvements in all parameters at the end of MKP. These parameters deteriorated again at nine months after MKP for most parameters and were even below the baseline levels. However, this deterioration was less pronounced in the IG than in the CG. For general health and social participation, a significant slightly positive effect was observed in the IG nine months after MKP when compared with the baseline level. Paying attention to physical activity slightly increased in the IG for the catamnesis survey compared to baseline. Nearly all IG patients were satisfied with the intervention, especially with the consultations with the physiotherapist.ConclusionsAlthough the expected extent of effects could not be determined for the IG, stabilisation effects could be demonstrated. These stabilisation effects shown for the IG might be attributed to the intervention. The effects might have been greater without the COVID-19 pandemic.Trial registration.German Register of Clinical Trials, drks.de. Identifier: DRKS00014952. Registered 20/06/2018. Date and version identifier 25/04/2019; version 1.

A quasi-randomised controlled trial of online distribution of home-based hepatitis C self-testing for key populations in Malaysia: a study protocol

BackgroundMalaysia has an estimated hepatitis C virus (HCV) prevalence of 1.9% among its adult population and a history of providing HCV treatment in the public sector. In 2019, Malaysia launched a 5-year national strategic plan for viral hepatitis control and has been expanding HCV testing and treatment to the primary care and community levels, while actively engaging key populations in services for hepatitis care. The Ministry of Health (MoH) is seeking to specifically understand how to better target HCV services at men who have sex with men (MSM); HCV self-testing could increase the uptake of HCV testing among this group.MethodsWe aim to integrate HCV antibody self-testing into an existing online platform used for HIV self-testing, to evaluate the acceptability and impact of an online HCV self-testing programme in Malaysia. This is a non-blinded parallel group quasi-randomised superiority study comparing HCV self-testing via an online distribution model with the standard care, which involves attending a clinic for facility-based HCV antibody testing (control, 2:1). Participants will be randomised to either the HCV self-testing via online distribution arm, in which either an oral fluid- or blood-based HCV self-test kit will be mailed to them, or the control arm, where they will be provided with information about the nearest centre with HCV testing. The primary outcome is the number and proportion of participants who report completion of testing. Secondary outcomes include the number and proportion of participants who (a) receive a positive result and are made aware of their status, (b) are referred to and complete HCV RNA confirmatory testing, and (c) start treatment. Acceptability, feasibility, attitudes around HCV testing, and cost will also be evaluated. The target sample size is 750 participants.DiscussionThis study is one of the first in the world to explore the real-world impact of HCV self-testing on key populations using online platforms and compare this with standard HCV testing services. The outcomes of this study will provide critical evidence about testing uptake, linkage to care, acceptability, and any social harms that may emerge due to HCV self-testing.Trial registrationClinicalTrials.gov NCT04982718

Effects of a group-based physical and cognitive intervention on social activity and quality of life for elderly people with dementia in a geriatric health service facility: a quasi-randomised controlled trial.

The aim of this study was to assess the effects of group-based motor and cognitive-combined intervention on social activity and quality of life. This quasi-randomised controlled trial included 31 elderly participants with dementia in a geriatric health service facility. Participants were randomly allocated to the intervention group (n = 16) or the control group (n = 15) by stratification of cognitive function. The 8-week intervention program consisted of group exercise and cognitive stimulation twice per week for 45 min per session. Outcome measures were social activity in daily behaviour, cognitive function, apathy, muscle and grip strength, independence of activity of daily living, life-space, and objective quality of life (QOL). Twenty-five participants were analysed (10 in the control group, 15 in the intervention group). Analysis of covariance with covariates of age, gender, and baseline data showed a significant difference in social activity (F = 8.67, P = 0.008; significant decline in control group vs. maintenance in intervention group) and QOL (F = 9.74, P = 0.006; maintenance in control group vs. tendency of improvement in intervention group). A Wilcoxon signed-rank test revealed that helping behaviour (P = 0.035) increased in the intervention group, whereas interest to the surrounding (P = 0.026) decreased in the control group. Group-based combined intervention for dementia is effective for maintaining social activity and QOL in a geriatric health service facility.

Carbohydrate supplementation of human milk to promote growth in preterm infants.

Preterm infants are born with low glycogen stores and require higher glucose intake to match fetal accretion rates. In spite of the myriad benefits of breast milk for preterm infants, it may not adequately meet the needs of these rapidly growing infants. Supplementing human milk with carbohydrates may help. However, there is a paucity of data on assessment of benefits or harms of carbohydrate supplementation of human milk to promote growth in preterm infants. This is a 2020 update of a Cochrane Review first published in 1999. To determine whether human milk supplemented with carbohydrate compared with unsupplemented human milk fed to preterm infants improves growth, body composition, and cardio-metabolic and neurodevelopmental outcomes without significant adverse effects. We used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL 2019, Issue 8) in the Cochrane Library and MEDLINE via PubMed on 22 August 2019. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials. Published and unpublished controlled trials were eligible if they used random or quasi-random methods to allocate preterm infants in hospital fed human milk to supplementation or no supplementation with additional carbohydrate. Two review authors independently abstracted data and assessed trial quality and the quality of evidence at the outcome level using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method. We planned to perform meta-analyses using risk ratios (RRs) for dichotomous data and mean differences (MDs) for continuous data, with their respective 95% confidence intervals (CIs). We planned to use a fixed-effect model and to explore potential causes of heterogeneity via sensitivity analyses. We contacted study authors for additional information. One unblinded, quasi-randomised controlled trial (RCT) assessing effects of carbohydrate supplementation of human milk in the form of a prebiotic in 75 preterm infants was eligible for inclusion in this review. We identified two publications of the same trial, which reported different methods regarding blinding and randomisation. Study authors confirmed that these publications pertain to the same trial, but they have not yet clarified which method is correct. We were unable to reproduce analyses from the data presented. At 30 days of age, the mean weight of preterm infants in the trial was greater in the prebiotic carbohydrate-supplemented group than in the unsupplemented group (MD 160.4 grams, 95% CI 12.4 to 308.4 grams; one RCT, N = 75; very low-quality evidence). We found no evidence of a clear difference in risk of feeding intolerance (RR 0.64, 95% CI 0.36 to 1.15; one RCT, N = 75 infants; very low-quality evidence) or necrotising enterocolitis (NEC) (RR 0.2, 95% CI 0.02 to 1.3; one RCT, N = 75 infants; very low-quality evidence) between the prebiotic-supplemented group and the unsupplemented group. Duration of hospital stay was shorter in the prebiotic group than in the control group at a median (range) of 16 (9 to 45) days (95% CI 15.34 to 24.09) and 25 (11 to 80) days (95% CI 25.52 to 34.39), respectively. No other data were available for assessing effects of carbohydrate supplementation on short- and long-term growth, body mass index, body composition, and neurodevelopmental or cardio-metabolic outcomes. We found insufficient evidence on the short- and long-term effects of carbohydrate supplementation of human milk in preterm infants. The only trial included in this review presented very low-quality evidence, and study authors provided uncertain information about study methods and analysis. The evidence may be limited in its applicability because researchers included a small sample of preterm infants from a single centre. However, the outcomes assessed are common to all preterm infants, and this trial demonstrates the feasibility of prebiotic carbohydrate supplementation in upper-middle-income countries. Future trials should assess the safety and efficacy of different types and concentrations of carbohydrate supplementation for preterm infants fed human milk. Although prebiotic carbohydrate supplementation in preterm infants is currently a topic of active research, we do not envisage that further trials of digestible carbohydrates will be conducted, as this is currently done as a component of multi-nutrient human milk fortification. Hence we do not plan to publish any further updates of this review.

The efficacy of regular penis-root masturbation, versus Kegel exercise in the treatment of primary premature ejaculation: A quasi-randomised controlled trial.

To explore the efficacy of regular penis-root masturbation (PRM) versus Kegel exercise (KE) in the treatment of primary premature ejaculation (PPE). This study was a prospective quasi-randomised controlled trial. Thirty-seven heterosexual males with PPE were selected according to the time sequence of outpatient consultations and the preliminary results of a pre-experiment and were assigned to an PRM group and a KE group. Differences in intravaginal ejaculatory latency times (IELTs) and premature ejaculation diagnostic tool (PEDT) scores were compared between the two groups. The study was approved by the Ethics Committee of the First Affiliated Hospital of Guangxi Medical University. Among the 37 PPE patients, 18 performed PRM and 19 patients performed KE. The IELTs of patients who performed PRM and KE were significantly prolonged before treatment, and the difference after treatment was statistically significant (p<.05). Compared with the KE group, the IELT prolongation effect in the PRM group was more significant PRM (p<.05). The PEDT scores of patients after performing PRM and KE were significantly lower than those before performing these exercises (p<.05). Compared with the KE group, the PEDT scores of the PRM group exhibited a greater decrease (p<.05). Thus, both PRM and KE have therapeutic effects on PPE. Compared with KE, PRM is more effective in the treatment of PPE.

Clinical information and guidance shared via a patient infotainment system can reduce hospital stay and maintain 2 medical quality for total knee arthroplasty: A single-blinded quasi-randomised controlled trial

BackgroundThe demand for total knee arthroplasty is increasing worldwide. Optimising results and meeting patients’ expectations are more challenging than before, because the length of hospitalisation has markedly reduced and the standard care processes have been accelerated. We incorporated an interactive patient infotainment system into the standard clinical pathway for total knee arthroplasty in the hope of improving patients’ length of stay. ObjectivesTo analyse whether incorporation of an interactive infotainment system reduced the length of stay and improved the quality of medical care (in terms of number of medical orders and emergency room returns). DesignA prospective, quasi-randomised controlled trial. Participants and SettingData of 86 patients hospitalised for a unilateral total knee arthroplasty at a medical centre in Taiwan were analysed. MethodsFrom January 2017 to July 2017, 86 patients who underwent unilateral total knee arthroplasty and were cared for under a standard clinical pathway were included. The study group (41 patients) had access to electronic programs and video demonstrations related to health literacy, physical therapy, home care and precautions following total knee arthroplasty via a patient infotainment system, while the control group (45 patients) did not. Hospital course, quality indices, in-hospital medical costs, returns to the emergency room and readmission at 30 or 90 days were analysed and compared between the two groups of patients. ResultsThe study group had a shorter length of stay (4.4 vs. 4.8 days, mean differences [MD] = −0.37, 95% CI −0.71 to −0.03, p = 0.026) and fewer medical orders (109 vs 111 orders, MD = −1.86, 95% confidence intervals (CI) −3.58 to −0.15, p = 0.047) as compared with the control group. The incidences of emergency room return and readmission to the hospital at 30 or 90 days were comparable between the two groups. No difference in the total medical cost was found between the two groups, with only the cost of laboratory tests in the study group being significantly lower than that in the control group ($144 vs. $163, MD = −21.7, 95% CI −41.0 to −2.25, p = 0.007). ConclusionsThe incorporation of a patient infotainment system into the standard clinical pathway for total knee arthroplasty can efficiently reduce the length of hospital stay and maintain the quality of medical care. Further studies on improvement of patient medical literacy with the help of the infotainment system would be of interest in order to improve clinical practice and patient satisfaction. Registration numberNCT03788798 Tweetable abstractA patient infotainment system can reduce hospital stay and maintain medical quality for total knee arthroplasty

Evaluating the effectiveness of the NHS Health Check programme in South England: a quasi-randomised controlled trial

ObjectiveTo evaluate uptake, risk factor detection and management from the National Health Service (NHS) Health Check (HC).DesignThis is a quasi-randomised controlled trial where participants were allocated to five cohorts based...

Impact of a mindfulness-based intervention on undergraduate pharmacy students' stress and distress: Quantitative results of a mixed-methods study

IntroductionStress negatively impacts upon physical and mental health. Pharmacy students demonstrate higher stress than the general population. Mindfulness may improve pharmacy students' stress and distress levels. The purpose of this study was to assess the quantitative effects of a mindfulness-based intervention on pharmacy student stress, distress, burnout, and mindfulness levels. MethodsA quasi-randomised controlled trial was conducted at an Irish pharmacy school during the 2016 to 2017 academic year. The intervention group completed a four-week mindfulness course. The waitlist control group received only usual education. Participants completed a demographics form, the Perceived Stress Scale, the General Health Questionnaire, the Maslach Burnout Inventory Student Survey, and the Five Facet Mindfulness Questionnaire at baseline and immediately post-intervention. ResultsFull data were gathered and analysed for 99 students (51 intervention, 48 control, 66.7% female). There were no significant differences between the intervention and control groups at baseline. Post-intervention, a large effect on mental distress was found (Partial Eta Squared 0.137) with the intervention group reporting statistically significantly lower distress than the control group (F (1,98) = 15.3, p < 0.005). Stress and distress were significantly improved for females (p = 0.026, p < 0.005), while males improved in the observing facet of mindfulness (p = 0.038). There was a positive association between attendance and these findings (r2 = 0.191, p < 0.005). ConclusionFemale pharmacy students experienced improvements in mental distress and stress after participation in the intervention. Mindfulness may have a future role to play in pharmacy and healthcare education.

An online mindfulness-based intervention for undergraduate pharmacy students: Results of a mixed-methods feasibility study

IntroductionStress negatively impacts pharmacy students' physical and mental health. Mindfulness has been shown to improve student wellbeing. The purpose of this study was to assess the feasibility and acceptability of an online mindfulness-based intervention and determine its effect on student wellbeing. MethodsA quasi-randomised controlled trial was conducted at four pharmacy schools in Ireland. The intervention group took part in a four-week online mindfulness course. The control group received usual education, with delayed access to the course. Participants completed the Perceived Stress Scale, the General Health Questionnaire, the Jefferson Scale of Empathy - Health Profession Student version, the Maslach Burnout Inventory Student Survey (MBI-SS), and the Five Facet Mindfulness Questionnaire at baseline and post-intervention. Answers provided to questions about the experience of participating in the course were analysed using thematic analysis. ResultsOf the 52 participants, no significant differences were found between the intervention and control groups at baseline. Post-intervention, an increase in professional efficacy, as measured by the MBI-SS, was found in the intervention group (p = 0.004). There was also an increase in observing scores (p = 0.003). Males showed greater improvements in stress (p = 0.04) and non-judgement (p = 0.03) levels. Only females demonstrated improvement in professional efficacy (p = 0.002). Participants self-reported stress reduction and increased awareness of emotions. ConclusionThis study provides insights into the feasibility and acceptability of an online mindfulness course for pharmacy students. Findings will inform the future design and implementation of larger studies.

Conservative management following closed reduction of traumatic anterior dislocation of the shoulder.

Conservative management following closed reduction of traumatic anterior dislocation of the shoulder.

Efficacy of elaborated semantic features analysis in Aphasia: a quasi-randomised controlled trial

ABSTRACTBackground: Word finding difficulty is one of the most common features of aphasia. Semantic Features Analysis (SFA) directly aims to improve word finding in people with aphasia. Evidence from systematic reviews suggests that SFA leads to positive outcomes, yet the evidence comprises single case studies and case series. There is a need to evaluate the efficacy of SFA in controlled group studies/trials.Aims: To evaluate the efficacy of Elaborated Semantic Feature Analysis (ESFA) for word finding in people with aphasia. We investigated: (a) the efficacy of ESFA versus a delayed therapy/control, (b) the efficacy of two therapy approaches – individual versus a combination of individual and group therapy.Methods and procedures: We ran a multi-centre, quasi-randomised controlled trial, nested in a larger study (Thales-Aphasia). Participants were recruited from community settings. They had to be people with aphasia due to stroke at least four months post-onset. Participants were randomized to individual vs combination vs delayed therapy/control groups. Both therapy groups had 3 h of ESFA per week for 12 weeks. Delayed therapy/control group had no intervention for 12 weeks and were then randomized to either individual or combination therapy. The primary outcome was confrontation naming. Secondary outcomes were the Boston Naming Test, Discourse, the Functional Assessment of Communication Skills for adults (ASHA–FACS), the Stroke and Aphasia Quality of Life scale (SAQOL-39g), the General Health Questionnaire-12 item, and the EQ-5D.Outcomes and Results: Of the 72 participants of the Thales-Aphasia project, 58 met eligibility criteria for speech-language therapy and 39 were allocated to ESFA. The critical p-value was adjusted for multiple comparisons (.005). For the therapy versus control comparison, there was a significant main effect of time on the primary outcome (p < .001, η2p = .42) and a significant interaction effect (p = .003, η2p = .21). An interaction effect for the SAQOL-39g (p = .015, η2p = .11) and its psychosocial domain (p = .013, η2p = .12) did not remain significant after Bonferroni adjustment. For the individual versus combination ESFA comparison, there were significant main effects of time on the primary outcome (p < .001, η2p = .49), the BNT (p < .001, η2p = .29) and the ASHA-FACS (p = .001, η2p = .18). Interaction and group effects were not significant.Conclusion: Though underpowered, this study provides evidence on the efficacy of ESFA to improve word finding in aphasia, with gains similar in the two therapy approaches.

A Pilot Study to Assess the Effects of Tai Chi on Health Indicators in Type 1 Diabetes Patients

Objective: Previous studies have shown that Tai Chi may have a role in the management of type 2 diabetes. However, to date, no studies have focused specifically on the effects of Tai Chi in people with type 1 diabetes. The aim of this pilot study was to evaluate the effects of a Tai Chi program on health indicators in adults with type 1 diabetes. Methods: This was a two-group quasi-randomised controlled trial with 13 participants (six men and seven women, aged 24 - 63 years) with type 1 diabetes. This trial was conducted from May to November 2016. The intervention group attended Tai Chi exercise training for 1 to 1.5 hours, twice a week for 12 weeks, and the control group continued with their usual medical care. Indicators of glycaemic control (HbA1c), depressive symptoms, physical measures (body mass index, waist circumference, blood pressure and leg strength), and health-related quality of life (physical and mental components summary scores) were assessed at baseline and 12 weeks’ post-intervention. Results: There were significant or borderline significant between-group differences in changes over time in favour of the intervention group in depressive symptoms (p < 0.01), waist circumfereance (p = 0.059), mental components summary score (p = 0.051) and leg strength (p < 0.05) during the 12 weeks’ intervention. Further, compared with baseline, significant improvements were observed in depressive symptoms (p < 0.05), mental components summary score (p < 0.05) and leg strength (p < 0.01) in the intervention group, but not in the control group. In contrast, there was a significant increase in waist circumference in the control group (p < 0.05) but not in the intervention group. Conclusion: In conclusion, there were improvements in mental health and leg strength in these adults with type 1 diabetes. Large studies are needed to further investigate the effects of Tai Chi in people with Type 1 diabetes.

Effect of persuasive messages on National Health Service Organ Donor Registrations: a pragmatic quasi-randomised controlled trial with one million UK road taxpayers

BackgroundA shortage of organs available for transplantation is causing loss of life. Increasing the number of individuals on the National Health Service (NHS) Organ Donor Register (ODR) is one way to address the shortage of organs. In Great Britain, new drivers registering for their driving licence are invited to join the ODR. A further 17 million drivers renew their road tax online each year, presenting an additional opportunity to prompt drivers to join the ODR. This trial explores the effect of adding persuasive messages to a prompt to join the ODR at the end of road tax payment transactions.MethodsIn this pragmatic, parallel group, quasi-randomised controlled trial, drivers renewing their road tax or registering for a driving licence were alternately allocated, using a JavaScript randomisation code embedded in the GOV.UK website, to view a control prompt inviting sign-ups to the ODR or the same prompt plus one of seven theoretically informed persuasive messages; (i) social norms alone, (ii) social norms plus the NHS ODR logo, (iii) social norms plus an image, (iv) loss frame, (v) gain frame, (vi) reciprocity and (vii) cognitive dissonance. The trial took place over a 4-week period in June 2013. The primary outcome measure was participants completing the online registration form (sign-ups).ResultsAltogether, 1,085,322 website users were included in the study. Further, 1171 more sign-ups were completed under the most effective message (reciprocity) compared to the control prompt alone (reciprocity: n = 4256, control: n = 3085; odds ratio, OR 1.38, 95% confidence interval 1.32–1.45, p < 0.001). The loss-framed message was as effective. All messages increased sign-ups compared to the control prompt apart from the social norms message plus image (n = 2879; OR 0.94, 95% confidence interval 0.89–0.99, p < 0.05).ConclusionsShort persuasive messages alongside a prompt can persuade more ODR sign-ups for individuals renewing their road tax than a prompt alone. The most effective message remains in place today. Since the trial in 2013, the same message has been implemented across 25 government end-of-transaction websites on GOV.UK, resulting in 529,000 new registrations to the ODR up to 31st October 2017.