Pseudo-randomized Controlled Trial Research Articles

Effectiveness of erector spinae plane block for rib fracture analgesia: a systematic review protocol.

This systematic review will investigate the effectiveness of the ultrasound-guided erector spinae plane block as an analgesic technique for patients with rib fractures compared with all other standard management techniques. Comparisons will be made with both nerve blocks (neuraxial techniques and peripheral nerve blocks) and systemic treatment (with patient-controlled analgesia and/or per required need analgesia for breakthrough pain). Erector spinae plane block is a well-established rescue analgesia option for patients with rib fractures. The use of ultrasound-guided erector spinae plane block in clinical practice has been largely based on observational data, with recent randomized controlled trials examining it against several other options for analgesic management. This review will compare the erector spinae against all other management techniques used in practice for rib fractures to determine whether this is the most effective analgesic technique. The review will include all randomized controlled and pseudo-randomized controlled trials examining ultrasound-guided erector spinae plane block for the analgesic management of traumatic rib fractures. All other study designs will be excluded. MEDLINE (PubMed), Embase (Ovid), CINAHL (EBSCOhost), the Cochrane Central Register of Controlled Trials, the Australian and New Zealand Clinical Trials Registry (ANZCTR), ClinicalTrials.gov, and the ISRCTN registry will be searched to identify all relevant ongoing clinical trials. Study selection, critical appraisal, and data extraction will be performed by 2 independent reviewers. Data will be extracted into software for statistical analysis (including meta-analysis where possible). PROSPERO CRD42023414849.

Agitated Behaviors following Traumatic Brain Injury: A Systematic Review and Meta-Analysis of Prevalence by Post-Traumatic Amnesia Status, Hospital Setting, and Agitated Behavior Type.

Agitation is a common behavioral problem following traumatic brain injury (TBI); however, the precise proportion of patients who experience agitation in the early stages of recovery is unknown. The aim of this systematic review and meta-analysis was to evaluate the prevalence of agitation in TBI patients undergoing inpatient care, and whether this prevalence differed by post-traumatic amnesia (PTA) status and setting (acute and rehabilitation). We also aimed to describe the prevalence of sub-types of agitated behavior (disinhibited, aggressive, and emotionally labile). We searched five databases and one clinical trials register, with additional review of websites and key journals to identify any relevant records up to July 2020. We included studies describing the proportion of hospitalized TBI patients age 16 years or older demonstrating agitated behavior. We included comparative studies with and without concurrent controls, randomized controlled trials, pseudo-randomized controlled trials, and case series. Methodological quality was critically appraised using a Joanna Briggs Institute checklist. Sixteen studies met eligibility criteria, with a total of 5592 participants. The pooled prevalence of agitation was 31.73% (95% confidence interval [CI], 25.25%-39.00%) during inpatient care (acute and rehabilitation), 32.23% (95% CI, 27.13%-37.80%) during rehabilitative care and 44.06% (95% CI, 36.15%-52.28%) for inpatients in PTA specifically. Disinhibited behaviors were the most common. There was substantial heterogeneity between studies. Additional high-quality research featuring large samples, frequent and long-term measurement of agitation, use of validated scales, and consideration of variables such as PTA status will further improve estimates of agitation prevalence following TBI.

Effectiveness of early high-intensity balance training for early home life independence after total knee arthroplasty: a pseudo-randomized controlled trial.

In Japan, the number of elderly individuals living alone is increasing, leading to an increase in hospital medical expenses attributed to total knee arthroplasty (TKA). Improvement in balance and functional performance is a priority in the early postoperative stages after TKA. However, there are no reports on the effectiveness of balance training (BT) for inpatients in the early postoperative period. Thus, we aimed to evaluate the effectiveness of early high-intensity BT for early home-life independence after TKA. This pseudo-randomized controlled trial included 49 inpatients who underwent TKA and had osteoarthritis. Inpatients were categorized into the BT or typical training (TT) group. The BT program began on post-TKA day 4, with 12-14 sessions between day 7 and 10 (i.e., 1-2 sessions per day). The effect of the intervention was assessed using balance ability as the main outcome. Sub-outcomes included evaluation of motion function. The differences in each variable before and after intervention were compared, including covariance analysis adjusted for age and sex. The mean (standard deviation) balance ability indexes in the left and right directions were BT, pre 4.5 (0.8) and post 4.4 (0.8); TT, pre 4.8 (0.9) and post 4.4 (0.8), and those in the forward and backward directions were BT, pre 4.7 (1.7) and post 5.1 (2.1); TT, pre 6.3 (2.6) and post 5.9 (2.0). No significant differences were found between the preoperative and postintervention scores in the two groups for any measured outcome. BT did not appear to improve balance ability or functional performance.

Effects of an mHealth voice message service (mMitra) on maternal health knowledge and practices of low-income women in India: findings from a pseudo-randomized controlled trial

BackgroundMobile Health (mHealth) is becoming an important tool to improve health outcomes in maternal, newborn and child health (MNCH). Studies of mHealth interventions, have demonstrated their effectiveness in improving uptake of recommended maternal services such as antenatal visits. However, evidence of impact on maternal health outcomes is still limited.MethodsA pseudo-randomized controlled trial (single blind) was conducted to assess the impact of a voice-message based maternal intervention on maternal health knowledge, attitudes, practices and outcomes over time: Pregnancy (baseline/Time 1); Post-partum (Time 2) and when the infant turned one year old (Time 3). Women assigned to the mMitra intervention arm received gestational age- and stage-based educational voice messages via mobile phone in Hindi and Marathi, while those assigned to the control group did not. Both groups received standard care.ResultsTwo thousand sixteen women were enrolled. Interviews were conducted with 1516 women in the intervention group and 500 women in the control group at baseline and post-partum. The intervention group performed significantly better than controls on four maternal health practice indicators: receiving the tetanus toxoid injection (OR: 1.6, 95% Confidence Interval (CI): 1.05–2.4, p = 0.028), consulting a doctor if spotting or bleeding (OR: 1.72, 95%CI: 1.07–2.75, p = 0.025), saving money for delivery expenses (OR: 1.79, 95%CI: 1.38–2.33, p = 0.0001), and delivering in hospital (OR: 2.5, 95%CI: 1.49–4.35, p = 0.001). The control group performed significantly better than the intervention group on two practice indicators: resting regularly during pregnancy (OR: 0.7, 95%CI: 0.54–0.88, p = 0.002) and having at-home deliveries attended by a skilled birth attendant (OR: 0.46, 95%CI: 0.23–0.91, p = 0.027). Both groups’ knowledge improved from Time 1 to Time 2. Only one knowledge indicator, on seeking medical care during pregnancy, was statistically increased in the intervention group compared to controls. Anemia status at or near the time of delivery was unable to be assessed due to missing data from maternal health cards.ConclusionsThis study provides evidence that in low-resource settings, mobile voice messages providing tailored and timed information about pregnancy can positively impact maternal health care practices proven to improve maternal health outcomes. Additional research is needed to assess whether voice messaging can motivate behavior change better than text messaging, particularly in low literacy settings.Trial registrationThe mMitra impact evaluation is registered with ISRCTN under Registration # 88968111, assigned on 6 September 2018 (See https://www.isrctn.com/ISRCTN88968111).

Non-inferior comparative study comparing one or two day antimicrobial prophylaxis after clean orthopaedic surgery (NOCOTA study): a study protocol for a cluster pseudo-randomized controlled trial comparing duration of antibiotic prophylaxis

BackgroundAntimicrobial prophylaxis (AMP) is one of the most important measures for preventing surgical site infections (SSIs); however, controversies remain regarding its adequate duration. Although the World Health Organization and the Center for Disease Control and Prevention do not recommend additional AMP after closure, the American Society of Health-System Pharmacists and the Musculoskeletal Infection Society permit the use of postoperative AMP, but recommend discontinuation within 24 h. Similarly, the Japanese Society of Chemotherapy and the Japan Society for Surgical Infection also permit AMP within 24–48 h after various orthopaedic procedures. In these guidelines, recommendations regarding AMP duration were weak due to a relative lack of evidence, and currently, there is no high-quality evidence comparing AMP use within 24 h versus 24–48 h regarding orthopaedic procedures. Urinary tract infection (UTI) and respiratory tract infection (RTI) are also important health care-associated infections (HAIs) faced after surgery. Although AMP duration may affect these HAIs, its effects have not been well evaluated.MethodsWe have organized a multicenter, prospective, cluster pseudo-randomized controlled trial to examine the non-inferiority of shorter AMP duration (within 24 h) against longer duration (24–48 h) in preventing postoperative HAIs. Participating facilities will be divided into two groups. In Group 24, AMP will be discontinued within 24 h after surgery. In Group 48, AMP will be discontinued within 24–48 h after surgery. The group allocation will be switched every 2 months until the targeted recruitment (500 participants per group) is met.The primary outcome will be the cumulative incidence of all HAIs (SSI, UTI, RTI, and other infectious diseases), which require antibiotic therapies within 30 days after surgery. In addition to mortality and cardiovascular events, prolonged hospitalization (> 30 days) and the rate of antibiotic resistance rate of SSI pathogens will also be evaluated. Outcomes will be evaluated within 30–180 days after surgery in person by the surgeon, by mail, or by telephone survey. Data will be analyzed by a statistician not engaged in data collection.DiscussionThis study may provide valuable information for developing future recommendations for adequate AMP duration after clean orthopaedic surgery.Trial registrationUMIN000030929, registered January 22, 2018.

The Impact of an mHealth Voice Message Service (mMitra) on Infant Care Knowledge, and Practices Among Low-Income Women in India: Findings from a Pseudo-Randomized Controlled Trial

Objectives mHealth interventions for MNCH have been shown to improve uptake of antenatal and neonatal services in low- and middle-income countries (LMICs). However, little systematic analysis is available about their impact on infant health outcomes, such as reducing low birth weight or malnutrition among children under the age of five. The objective of this study is to determine if an age- and stage-based mobile phone voice messaging initiative for women, during pregnancy and up to 1 year after delivery, can reduce low birth weight and child malnutrition and improve women’s infant care knowledge and practices. Methods We conducted a pseudo-randomized controlled trial among pregnant women from urban slums and low-income areas in Mumbai, India. Pregnant women, 18 years and older, speaking Hindi or Marathi were enrolled and assigned to receive mMitra messages (intervention group N = 1516) or not (Control group N = 500). Women in the intervention group received mMitra voice messages two times per week throughout their pregnancy and until their infant turned 1 year of age. Infant’s birth weight, anthropometric data at 1 year of age, and status of immunization were obtained from Maternal Child Health (MCH) cards to assess impact on primary infant health outcomes. Women’s infant health care practices and knowledge were assessed through interviews administered immediately after women enrolled in the study (Time 1), after they delivered their babies (Time 2), and after their babies turned 1 year old (Time 3). 15 infant care practices self-reported by women (Time 3) and knowledge on ten infant care topics (Time 2) were also compared between intervention and control arms. Results We observed a trend for increased odds of a baby being born at or above the ideal birth weight of 2.5 kg in the intervention group compared to controls (odds ratio (OR) 1.334, 95% confidence interval (CI) 0.983–1.839, p = 0.064). The intervention group performed significantly better on two infant care practice indicators: giving the infant supplementary feeding at 6 months of age (OR 1.4, 95% CI 1.08–1.82, p = 0.009) and fully immunizing the infant as prescribed under the Government of India’s child immunization program (OR 1.531, 95% CI 1.141–2.055, p = 0.005). Women in the intervention group had increased odds of knowing that the baby should be given solid food by 6 months (OR 1.89, 95% CI 1.371–2.605, p < 0.01), that the baby needs to be given vaccines (OR 1.567, 95% CI 1.047–2.345, p = 0.028), and that the ideal birth weight is > 2.5 kg (OR 2.279, 95% CI 1.617–3.213, p < 0.01). Conclusions for Practice This study provides robust evidence that tailored mobile voice messages can significantly improve infant care practices and maternal knowledge that can positively impact infant child health. Furthermore, this is the first prospective study of a voice-based mHealth intervention to demonstrate a positive impact on infant birth weight, a health outcome of public health importance in many LMICs.

A targeted promotional DVD fails to improve M\u0101ori and Pacific participation rates in the New Zealand bowel screening pilot: results from a pseudo-randomised controlled trial

BackgroundNew Zealand’s Bowel Screening Pilot (BSP) used a mailed invitation to return a faecal immunochemical test. As a pilot it offered opportunities to test interventions for reducing ethnic inequities in colorectal cancer screening prior to nationwide programme introduction. Small media interventions (e.g. educational material and DVDs) have been used at both community and participant level to improve uptake. We tested whether a DVD originally produced to raise community awareness among the Māori population would have a positive impact on participation and reduce the proportion of incorrectly performed tests (spoiled kits) if mailed out with the usual reminder letter.MethodsThe study was a parallel groups pseudo-randomised controlled trial. Over 12 months, all Māori and Pacific ethnicity non-responders four weeks after being mailed the test kit were allocated on alternate weeks to be sent, or not, the DVD intervention with the usual reminder letter. The objective was to determine changes in participation and spoiled kit rates in each ethnic group, determined three months from the date the reminder letter was sent. Participants and those recording the outcomes (receipt of a spoiled or non-spoiled test kit) were blinded to group assignment.Results2333 Māori and 2938 Pacific people participated (11 withdrew). Those who were sent the DVD (1029 Māori and 1359 Pacific) were less likely to participate in screening than those who were not (1304 Māori and 1579 Pacific). Screening participation was reduced by 12.3% (95% CI 9.1–15.5%) in Māori (13.6% versus 25.9%) and 8.3% (95% CI 5.8–10.8%) in Pacific (10.1% versus 18.4%). However, spoiled kit rates (first return) were significantly higher among those not sent the DVD (33.1% versus 12.4% in Māori and 42.1% versus 21.9% in Pacific).ConclusionThe DVD sent with the reminder letter to BSP non-responders reduced screening participation to an extent that more than offset the lower rate of spoiled kits.Trial registrationAustralia and New Zealand Clinical Trials Registry ACTRN12612001259831. Registered 30 November 2013.

Strategies for implementing shared decision making in elective surgery by health care practitioners: A systematic review.

To summarize relevant international scientific evidence on strategies aimed at facilitating or improving health care practitioners' adoption of shared decision making in elective surgery. The review evaluated the effectiveness of these strategies and described the characteristics of identified strategies. A systematic search of the literature was conducted up to March 2019. The review included interventions that targeted patients, health care practitioners, or health systems/organizations. Main outcomes were measures of decision process and decision outcomes. Two independent reviewers conducted study selection, assessed methodological quality and extracted data. Fifteen randomized controlled trials, one pseudo-randomized controlled trial, and four quasi-experimental studies were included in this review. The heterogeneity of interventions and the variability of outcomes used to measure the impact of these interventions precluded meta-analysis. All of the interventions included an educational component regarding the medical condition of interest and available treatment options and a supportive component to encourage patients to ask questions and involve themselves in the decision making. Published evidence on shared decision-making interventions in elective surgery is most prevalent in the breast cancer/endocrine and urology specialties, with most studies targeting their shared decision-making interventions at the patient population. The use of multiple media components within an intervention including interactive video appeared to improve patient satisfaction with the shared decision-making process. The use of well-developed educational information provided through interactive multimedia, computer or DVD based, may enhance the decision-making process. The evidence suggests that such multimedia can be used prior to the surgical consultation, presenting medical and surgical information relevant to the upcoming consultation. A decision and communication aid also appears to be an effective method to support the surgeon in patient participation and involvement in the decision-making process.

The Elusive Path Toward Measuring Health Outcomes: Lessons Learned From a Pseudo-Randomized Controlled Trial of a Large-Scale Mobile Health Initiative.

Mobile health (mHealth) offers new opportunities to improve access to health services and health information. It also presents new challenges in evaluating its impact, particularly in linking the use of a technology intervention that aims to improve health behaviors with the health outcomes that are impacted by changed behaviors. The availability of data from a multitude of sources (paper-based and electronic) provides the conditions to facilitate making stronger connections between self-reported data and clinical outcomes. This commentary shares lessons and important considerations based on the experience of applying new research frameworks and incorporating maternal and child health records data into a pseudo-randomized controlled trial to evaluate the impact of mMitra, a stage-based voice messaging program to improve maternal, newborn, and child health outcomes in urban slums in India.

Effects of Whole-Body Vibration on Motor Impairments in Patients With Neurological Disorders: A Systematic Review.

This systematic review was conducted to examine the effects of whole-body vibration training on motor impairments among patients with neurological disorders and to investigate which the whole-body vibration training parameters induced improvement in motor impairments. PubMed, SCOPUS, PEDro, REHABDATA, and Web of Science were searched for randomized controlled trials and pseudo-randomized controlled trials investigated the effect of whole-body vibration on motor impairments in patients with neurological disorders. The methodological quality was rated using the Cochrane Collaboration's tool. Twenty studies were included in this systematic review. Four studies included patients with multiple sclerosis, cerebral palsy (n = 2), stroke (n = 9), Parkinson disease (n = 3), spinal cord injuries (n = 1), and spinocerebellar ataxia (n = 1). The results showed different evidence of benefits and nonbenefits for whole-body vibration training in motor impairments outcomes. There is weak evidence for a positive effect of short-term whole-body vibration training on spasticity of lower limbs, mobility, balance, and postural control. Besides, positive effect of the long-term effect of whole-body vibration training on mobility in patients with neurological disorders. The optimal whole-body vibration training parameters in treating patients with neurological disorders remain unclear.

Interventions combined with task-specific training to improve upper limb motor recovery following stroke: a systematic review with meta-analyses

Background: Upper limb (UL) hemiparesis is a common, disabling and persistent problem, and a major contributor to poor well-being and quality of life in persons after stroke. Conventional UL rehabilitation has had limited success. Novel combined interventions are being investigated in an effort to stimulate greater recovery.Objective: To identify and assess the efficacy of interventions combined with task-specific training aimed at UL motor recovery after stroke.Methods: A systematic search was undertaken in databases including MEDLINE, MEDLINE In-Process, EMBASE, AMED, CINAHL, OTseeker, and PEDro. Key inclusion criteria were: peer-reviewed articles published in English, adults after stroke, and an intervention combined with task-specific training targeted to improve motor function and/or impairment of the UL following stroke. Findings from included studies were synthesized qualitatively and meta-analyzed where there was sufficient homogeneity.Results: From 3494 citations identified, 120 papers (72 randomized controlled trials and 4 pseudo-randomized controlled trials) were included. Adjunctive interventions (21 categories) identified included electrical stimulation, transcranial magnetic stimulation, robotic devices, mental practice, action observation, trunk restraint, virtual reality, and resistance training. Of the interventions meta-analyzed, only peripheral nerve stimulation demonstrated small additional benefits over those of task-specific training alone for UL impairment, as measured by the Fugl-Meyer scale (MD 2.69, 95% CI 1.12, 4.26). Several individual studies found benefits for other interventions combined with task-specific training, but further investigations are needed to provide more comprehensive evidence of their efficacy.Conclusion: To date, there is little evidence that adding another intervention to TST confers additional benefits and therefore there is no evidence to guide rehabilitation professionals. Further research is required as heterogeneity of studies limited ability to conduct meta-analyses.

Intermittent fasting interventions for the treatment of overweight and obesity in adults aged 18 years and over: a systematic review and meta-analysis

Objective: To examine the effectiveness of intermittent energy restriction in the treatment for overweight and obesity in adults, when compared to usual care treatment or no treatment. Introduction: Intermittent energy restriction encompasses dietary approaches including intermittent fasting, alternate day fasting, and fasting for two days per week. Despite the recent popularity of intermittent energy restriction and associated weight loss claims, the supporting evidence base is limited. Inclusion criteria: This review included overweight or obese (BMI ≥25 kg/m2) adults (≥18 years). Intermittent energy restriction was defined as consumption of ≤800 kcal on at least one day, but no more than six days per week. Intermittent energy restriction interventions were compared to no treatment (ad libitum diet) or usual care (continuous energy restriction ∼25% of recommended energy intake). Included interventions had a minimum duration of 12 weeks from baseline to post outcome measurements. The types of studies included were randomized and pseudo-randomized controlled trials. The primary outcome of this review was change in body weight. Secondary outcomes included: i) anthropometric outcomes (change in BMI, waist circumference, fat mass, fat free mass); ii) cardio-metabolic outcomes (change in blood glucose and insulin, lipoprotein profiles and blood pressure); and iii) lifestyle outcomes: diet, physical activity, quality of life and adverse events. Methods: A systematic search was conducted from database inception to November 2015. The following electronic databases were searched: MEDLINE, Embase, CINAHL, Cochrane Library, ClinicalTrials.gov, ISRCTN registry, and anzctr.org.au for English language published studies, protocols and trials. Two independent reviewers evaluated the methodological quality of included studies using the standardized critical appraisal instruments from the Joanna Briggs Institute. Data were extracted from papers included in the review by two independent reviewers using the standardized data extraction tool from the Joanna Briggs Institute. Effect sizes were expressed as weighted mean differences and their 95% confidence intervals were calculated for meta-analyses. Results: Six studies were included in this review. The intermittent energy restriction regimens varied across studies and included alternate day fasting, fasting for two days, and up to four days per week. The duration of studies ranged from three to 12 months. Four studies included continuous energy restriction as a comparator intervention and two studies included a no treatment control intervention. Meta-analyses showed that intermittent energy restriction was more effective than no treatment for weight loss (−4.14 kg; 95% CI −6.30 kg to −1.99 kg; p ≤ 0.001). Although both treatment interventions achieved similar changes in body weight (approximately 7 kg), the pooled estimate for studies that investigated the effect of intermittent energy restriction in comparison to continuous energy restriction revealed no significant difference in weight loss (−1.03 kg; 95% CI −2.46 kg to 0.40 kg; p = 0.156). Conclusions: Intermittent energy restriction may be an effective strategy for the treatment of overweight and obesity. Intermittent energy restriction was comparable to continuous energy restriction for short term weight loss in overweight and obese adults. Intermittent energy restriction was shown to be more effective than no treatment, however, this should be interpreted cautiously due to the small number of studies and future research is warranted to confirm the findings of this review.

A systematic review of the efficacy of creative arts therapies in the treatment of adults with PTSD.

There is a growing body of literature supporting the use of creative arts therapies; however, the efficacy of creative arts therapies in the treatment of posttraumatic stress disorder (PTSD) has not been systematically evaluated. The aim of this systematic review was to examine the efficacy of creative arts therapy including music therapy, art therapy, dance/movement therapy, and drama therapy, in the treatment of PTSD. Ten databases were searched for peer-reviewed literature published from inception to December 2016. Studies were included in the review if they used a randomized controlled trial (RCT), a pseudo RCT, or a controlled study design; tested the efficacy of one of the creative arts therapies described above; and reported changes to PTSD diagnosis or symptomatology. From an initial yield of 1,918 records, 1,653 records were screened on title and abstract and 125 were screened at full-text. Seven studies met the inclusion criteria for review, with four studies investigating art therapy, two studies investigating music therapy, and a final study investigating drama therapy. Individual studies were initially rated on a standardized quality and bias checklist, and then GRADE was used to rate the overall evidence for each intervention. The evidence for music therapy, art therapy, and drama therapy was ranked as low to very low, with no studies found for dance/movement therapy. Generally, the quality of the trials was very poor. Future directions for this field of research are to improve the scientific quality of the research trials in this area. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Impact of near infrared light in pediatric blood drawing Centre on rate of first attempt success and time of procedure

BackgroundPeripheral blood access and venipuncture are a stressful and painful experience in pediatric patients; moreover, it is estimated that more than one attempt is required to achieve the procedure in about one third of children. For this reason, we investigated if Near-infrared light technology routinely used, could give an advantage to venipuncture in a pediatric blood center setting.MethodsWe conducted an open, pseudo-randomized controlled trial with two parallel arms, in the blood-drawing center, with enrolment of 115 patients between 0 and 18 years, in 14 consecutive working days. Fifty-three subjects were enrolled in group 1 (VeinViewer®) and 62 in group 2 (control group). We divided patients into three subgroups considering their age (< 5 years, 6–10 years, > 10 years). The primary study outcome was to assess if the use of VeinViewer® was associated with a reduction of time to perform blood sampling. The secondary outcome was to analyze VienViewer®‘s impact on first attempt success rate in blood sampling.ResultsNo difference was found regarding the duration of blood sampling between the two groups, even after stratifying the patients into the three age subgroups. There was no difference between the two groups in the success at the first attempt in blood sampling.ConclusionsRoutine use of VeinViewer® is not useful to reduce time of the procedure during venipuncture.Trial registrationThe study was registered with ClinicalTrials.gov, with number NCT03277092, on September 8, 2017.

Relationship Between Leaving Children at Home Alone and Their Mental Health: Results From the A-CHILD Study in Japan.

Leaving children at home alone is considered a form of “neglect” in most developed countries. In Japan, this practice is not prohibited, probably because this country is considered to have relatively safe communities for children. The impact of leaving children at home alone on their mental health is a controversial issue, and few studies have examined it to date. The aim of this study was to examine the impact of leaving children aged 6 or 7 years at home alone on their mental health, focusing on both the positive and negative aspects; that is, resilience, difficult behavior, and prosocial behavior. Data from the Adachi Child Health Impact of Living Difficulty (A-CHILD) study were used. The caregivers of all children in the first grade in Adachi City, Tokyo, were targeted, of whom 80% completed the questionnaire (n = 4,291). Among the analytical sample which comprises those who completed both exposure and outcome variables (n = 4,195), 2,190 (52.2%) children had never been left at home alone, 1,581 (37.7%) children were left at home alone less than once a week, and 424 (10.1%) children were left at home alone once a week or more. Child resilience was measured using the Children's Resilient Coping Scale, and difficult behavior (emotional symptoms, conduct problems, hyperactivity/inattention, and peer relationship problems) and prosocial behavior using the Strength and Difficulty Questionnaire. Multivariate regression analyses were performed to examine the dose-response association between leaving children at home alone and child mental health, followed by propensity-score matching as a pseudo-randomized controlled trial to reduce potential confounding. The results showed that leaving children at home alone once a week or more, but not less than once a week, was associated with total difficulties scores, especially conduct problems, hyperactivity/inattention, and peer relationship problems. These findings indicate that leaving children at home alone should be avoided in Japan, as is recommended in North America.

Intermittent fasting interventions for treatment of overweight and obesity in adults: a systematic review and meta-analysis.

To examine the effectiveness of intermittent energy restriction in the treatment for overweight and obesity in adults, when compared to usual care treatment or no treatment. Intermittent energy restriction encompasses dietary approaches including intermittent fasting, alternate day fasting, and fasting for two days per week. Despite the recent popularity of intermittent energy restriction and associated weight loss claims, the supporting evidence base is limited. This review included overweight or obese (BMI ≥25 kg/m) adults (≥18 years). Intermittent energy restriction was defined as consumption of ≤800 kcal on at least one day, but no more than six days per week. Intermittent energy restriction interventions were compared to no treatment (ad libitum diet) or usual care (continuous energy restriction ∼25% of recommended energy intake). Included interventions had a minimum duration of 12 weeks from baseline to post outcome measurements. The types of studies included were randomized and pseudo-randomized controlled trials. The primary outcome of this review was change in body weight. Secondary outcomes included: i) anthropometric outcomes (change in BMI, waist circumference, fat mass, fat free mass); ii) cardio-metabolic outcomes (change in blood glucose and insulin, lipoprotein profiles and blood pressure); and iii) lifestyle outcomes: diet, physical activity, quality of life and adverse events. A systematic search was conducted from database inception to November 2015. The following electronic databases were searched: MEDLINE, Embase, CINAHL, Cochrane Library, ClinicalTrials.gov, ISRCTN registry, and anzctr.org.au for English language published studies, protocols and trials. Two independent reviewers evaluated the methodological quality of included studies using the standardized critical appraisal instruments from the Joanna Briggs Institute. Data were extracted from papers included in the review by two independent reviewers using the standardized data extraction tool from the Joanna Briggs Institute. Effect sizes were expressed as weighted mean differences and their 95% confidence intervals were calculated for meta-analyses. Six studies were included in this review. The intermittent energy restriction regimens varied across studies and included alternate day fasting, fasting for two days, and up to four days per week. The duration of studies ranged from three to 12 months. Four studies included continuous energy restriction as a comparator intervention and two studies included a no treatment control intervention. Meta-analyses showed that intermittent energy restriction was more effective than no treatment for weight loss (-4.14 kg; 95% CI -6.30 kg to -1.99 kg; p ≤ 0.001). Although both treatment interventions achieved similar changes in body weight (approximately 7 kg), the pooled estimate for studies that investigated the effect of intermittent energy restriction in comparison to continuous energy restriction revealed no significant difference in weight loss (-1.03 kg; 95% CI -2.46 kg to 0.40 kg; p = 0.156). Intermittent energy restriction may be an effective strategy for the treatment of overweight and obesity. Intermittent energy restriction was comparable to continuous energy restriction for short term weight loss in overweight and obese adults. Intermittent energy restriction was shown to be more effective than no treatment, however, this should be interpreted cautiously due to the small number of studies and future research is warranted to confirm the findings of this review.

Telerehabilitation Versus Standard Care for Improving Cognitive Function and Quality of Life for Adults with Traumatic Brain Injury: a Systematic Review

ABSTRACT Traumatic brain injury (TBI) is the most significant cause of death and severe disability following major trauma within Australia. Populations at risk include young adults aged 15 to 34, older adults, and military personnel. The main form of intervention following traumatic brain injury is rehabilitation, which places a large demand on the healthcare system. Telerehabilitation involves interventions delivered via telecommunication, which can improve accessibility and reduce this burden. There have been no systematic reviews conducted on the effectiveness of telerehabilitation in treating traumatic brain injury. Purpose: To examine the effectiveness of telerehabilitation for adults with traumatic brain injury. Methods: A systematic search of Medline, Embase, the Cumulative Index of Nursing and Allied Health Literature (CINAHL), Scopus, The Cochrane Library, OTSeeker and Google Scholar was conducted. Studies were included with participants aged 18 to 64 with traumatic brain injury and receiving telerehabilitation interventions. Methodological quality was assessed using the critical appraisal tools: Critical Appraisal Skills Programme (CASP) checklist for randomised controlled trials, and McMaster Critical Review for Quantitative Studies for non-randomised studies. Results: Three randomised controlled trials, one pseudo-randomised controlled trial, one case-control trial and one pre-post case series were included in this systematic review. Critical appraisal of the included studies revealed overall methodological quality to be moderate. A range of interventions with differing parameters were used as part of telerehabilitation. Collectively, there is some consistent evidence to indicate that telerehabilitation may be equally effective as other forms of care in the delivery of cognitive and psychological interventions, in addressing memory and depressive symptoms for adults with mild to severe traumatic brain injury. However, it is unclear if it is superior to other forms of care. Conclusions: A small number of studies have investigated the effect of telerehabilitation for adults with traumatic brain injury. The current evidence base is limited due to lack of standardised intervention parameters, outcomes measures and robust sample size. Despite these limitations, telerehabilitation may offer a complementary model of care for adults with traumatic brain injury, especially in instances where traditional models of care may not be readily accessible (such as those in rural and remote areas).

Laparoscopic and robot-assisted vs open radical prostatectomy for the treatment of localized prostate cancer: a Cochrane systematic review.

To determine the effects of laparoscopic radical prostatectomy (LRP), or robot-assisted radical prostatectomy (RARP) compared with open radical prostatectomy (ORP) in men with localized prostate cancer. We performed a comprehensive search using multiple databases (CENTRAL, MEDLINE, EMBASE) and abstract proceedings, with no restrictions on the language of publication or publication status, up until 9 June 2017. We included all randomized or pseudo-randomized controlled trials that directly compared LRP and RARP with ORP. Two review authors independently examined full-text reports, identified relevant studies, assessed the eligibility of studies for inclusion, extracted data and assessed risk of bias. We performed statistical analyses using a random-effects model and assessed the quality of the evidence according to Grading of Recommendations Assessment, Development and Evaluation (GRADE). The primary outcomes were prostate cancer-specific survival, urinary quality of life and sexual quality of life. Secondary outcomes were biochemical recurrence-free survival, overall survival, overall surgical complications, serious postoperative surgical complications, postoperative pain, hospital stay and blood transfusions. We included two unique studies in a total of 446 randomized participants with clinically localized prostate cancer. All available outcome data were short-term (up to 3 months). We found no study that addressed the outcome of prostate cancer-specific survival. Based on one trial, RARP probably results in little to no difference in urinary quality of life (mean difference [MD] -1.30, 95% confidence interval [CI] -4.65 to 2.05; moderate quality of evidence) and sexual quality of life (MD 3.90, 95% CI: -1.84 to 9.64; moderate quality of evidence). No study addressed the outcomes of biochemical recurrence-free survival or overall survival. Based on one trial, RARP may result in little to no difference in overall surgical complications (risk ratio [RR] 0.41, 95% CI: 0.16-1.04; low quality of evidence) or serious postoperative complications (RR 0.16, 95% CI: 0.02-1.32; low quality of evidence). Based on two studies, LRP or RARP may result in a small, possibly unimportant improvement in postoperative pain at 1 day (MD -1.05, 95% CI: -1.42 to -0.68; low quality of evidence) and up to 1 week (MD -0.78, 95% CI: -1.40 to -0.17; low quality of evidence). Based on one study, RARP probably results in little to no difference in postoperative pain at 12 weeks (MD 0.01, 95% CI: -0.32 to 0.34; moderate quality of evidence). Based on one study, RARP probably reduces the length of hospital stay (MD -1.72, 95% CI: -2.19 to -1.25; moderate quality of evidence). Based on two studies, LRP or RARP may reduce the frequency of blood transfusions (RR 0.24, 95% CI: 0.12-0.46; low quality of evidence). Assuming a baseline risk for a blood transfusion to be 8.9%, LRP or RARP would result in 68 fewer blood transfusions per 1,000 men (95% CI: 78-48 fewer). There is no evidence to inform the comparative effectiveness of LRP or RARP compared with ORP for oncological outcomes. Urinary and sexual quality of life appear similar. Overall and serious postoperative complication rates appear similar. The difference in postoperative pain may be minimal. Men undergoing LRP or RARP may have a shorter hospital stay and receive fewer blood transfusions.

Effect of square-stepping exercise on balance in older adults: A systematic review and meta-analysis

The physiological changes of normal ageing result in diminished input from visual, proprioceptive and vestibular systems, with reduction in the strength of the lower extremities and balance control among the elderly. This systematic review determined the effect of square-stepping exercise (SSE) on balance in older adults. PubMed, CINAHL (EBSCO), Embase, Scopus, the Cochrane Library and the Web of Science database were searched using specific keywords for randomized controlled trials and pseudo-randomized controlled trials published 2006-2016. Two reviewers independently extracted data, which included specific details about study methods, populations, interventions, outcome measures and results. Eight studies were assessed. The meta-analysis of this study indicates that there was a large significant effect on balance [ES 0.94; confidence interval (CI), 0.36 to 1.52]. The strongest effect was found on the BBS [ES 1.83; confidence interval (CI), 0.52 to 3.15]. However, no statistically significant differences were observed between SSE and control groups regarding single leg balance with eyes closed and the Timed Up and Go (TUG) Test. Conclusions, SSE was effective for improving short-term balance in older adults and reduced their risk of falling. High-quality studies with large sample size, including more balance related fall and adherence outcomes measured over a longer period are necessary for further study.

Effects of twelve weeks of aerobic or strength training in addition to standard care in Parkinson's disease: a controlled study.

Physical exercise in addition to standard care (SC) in patients with Parkinson's disease (PD) is now a common practice in many care units. However, exercises can cover a wide range of interventions, and the specific effects of different interventions still deserve to be further investigated. The aim of this study was to compare the effects of 12 weeks of two different types of physical exercises with SC in patients suffering from PD. Pseudo-randomized controlled trial. University laboratory for outcomes, University Hospital Centre for interventions. Fifty-two outpatients suffering from mild to moderate PD at baseline. Participants were allocated to three groups: the strength training (ST) group performed individualized upper and lower limbs strength training, the aerobic training (AE) group performed tailored gradual aerobic cycling, and the third group received SC. The effects of the interventions on body function were assessed by measuring isokinetic concentric peak torque for knee extension and flexion, peak oxygen consumption (VO2peak) and peak work load (PWL) during an incremental maximal cycling test. Changes in mobility were evaluated from spatial-temporal gait features measured by mean of an accelerometer system and the Six-Minute Walk Distance (6MWD) Test. We used questionnaires to estimate health-related quality of life and habitual physical activity. No significant changes in any outcome measures occurred in the SC group. More than 80% of the participants adequately completed the AE and the ST interventions. The ST group significantly improved all peak torque measures (P≤0.01), except knee extension in the least affected side (P=0.13). This group also improved the PWL (P=0.009) and 6mwd (P=0.03). The AE group improved the VO2peak (P=0.02) and PWL (P<0.001). Physical fitness in patients with PD rapidly improved in compliance with training specificities, but better fitness hardly translated into better mobility and health-related quality of life. Physiotherapists can efficiently propose physical conditioning to patients with mild to moderate PD, but these interventions are insufficient to improve gait and participation. Notwithstanding, ST is an efficient intervention for improving walking capacity.