Cot-nursing using a heated, water-filled mattress and incubator care: a randomized clinical trial

Aims: To evaluate the thermal responses and weight gain in preterm infants nursed in a cot on a heated, water-filled mattress (HWM) compared with infants receiving care in an air-heated incubator and to compare mothers' stress, anxiety levels and perceptions of their infants in the two groups. Methods: Stable preterm infants weighing 1300 to 1500 g were enrolled, being randomly allocated to either the study group (n = 41) receiving care in a cot on an HWM, or the control group ( n = 33) receiving incubator care. The mean daily body temperature and episodes of cold stress and hyperthermia were recorded. Weight gain (g kg(-1) body weight d(-1)) was also calculated. The mothers completed questionnaires on their perceptions of their infants, and their anxiety and stress levels before randomization, and 2 - 3 wk later during the trial. Results: The mean body temperature was similar for the first week of the trial ( study group 36.9degreesC vs controls 36.9degreesC). There were no significant differences in the incidence of cold stress, while more hyperthermic episodes were seen in the study group ( p = 0.03). There were no significant differences in weight gain during the first ( study group 21.4 g vs controls 19.6 g) or second weeks of the trial ( study group 20.5 g vs controls 19.2 g). Neonatal morbidity did not differ between the groups. There were no differences in mothers' perceptions of their babies, or feelings of stress or anxiety. Conclusion: There were no differences between infants cot-nursed on an HWM and those receiving incubator care, with the exception of episodes of high temperature. The results suggest that the HWM may be used safely for low-weight preterm infants.

A randomized controlled trial of intensive neurophysiology education in chronic low back pain

Objectives: Cognitive-behavioral pain management programs typically achieve improvements in pain cognitions, disability, and physical performance. However, it is not known whether the neurophysiology education component of such programs contributes to these outcomes. In chronic low back pain patients, we investigated the effect of neurophysiology education on cognitions, disability, and physical performance. Methods: This study was a blinded randomized controlled trial. Individual education sessions on neurophysiology of pain (experimental group) and back anatomy and physiology (control group) were conducted by trained physical therapist educators. Cognitions were evaluated using the Survey of Pain Attitudes (revised) (SOPA(R)), and the Pain Catastrophizing Scale (PCS). Behavioral measures included the Roland Morris Disability Questionnaire (RMDQ), and 3 physical performance tasks; (1) straight leg raise (SLR), (2) forward bending range, and (3) an abdominal drawing-in task, which provides a measure of voluntary activation of the deep abdominal muscles. Methodological checks evaluated non-specific effects of intervention. Results: There was a significant treatment effect on the SOPA(R), PCS, SLR, and forward bending. There was a statistically significant effect on RMDQ; however, the size of this effect was small and probably not clinically meaningful. Discussion: Education about pain neurophysiology changes pain cognitions and physical performance but is insufficient by itself to obtain a change in perceived disability. The results suggest that pain neurophysiology education, but not back school type education, should be included in a wider pain management approach.

A randomized, controlled trial to determine the efficacy of paper tape in preventing hypertrophic scar formation in surgical incisions that traverse Langer's skin tension lines

Background: How a scar is managed postoperatively influences Its cosmetic outcome. After Suture removal, scars are susceptible to skin tension, which may be the trigger for hypertrophic scarring. Paper tape to support the scar may reduce multidirectional forces and prevent hypertrophic scarring. Methods: Seventy patients who had under gone cesarean section at the Royal Brisbane and Women's Hospital were randomized to treatment and control groups. Patients in the control group received no postoperative intervention. Patients in the treatment group applied paper tape to their scars for 12 weeks. Scars were assessed at 6 weeks, 12 weeks, and 6 months after surgery using Ultrasound to measure intradermal scar volume. Scars were also assessed using the International Clinical Recommendations. Results: Paper tape significantly decreased scar volume by a mean of 0.16 cm(3), (95 percent confidence Interval, 0.00 to 0.29 cm(3)) At 12 weeks after surgery, 41 percent of the control group developed hypertrophic scars compared with none in the treatment group (exact test, p = 0.003). In the treatment group, one patient developed a hypertrophic scar and four developed stretched scars only after the tape was removed. The odds of developing a hypertrophic scar were 13.6 times greater in the control than in the treatment group (95 percent confidence interval, 3.6 to 66.9). Of the 70 patients randomized, 39 completed the study. Four patients in the treatment group developed a localized red rash beneath the tape. These reactions were minor and transient and resolved without medical intervention. Conclusions: The development of hypertrophic and stretched scars in the treatment group only after the tape was removed suggests that tension acting on a scar is die trigger for hypertrophic scarring. Paper tape is likely to be an effective modality for the prevention of hypertrophic scarring through its ability to eliminate scar tension.

Randomized controlled trial of an educational intervention for managing fatigue in women receiving adjuvant chemotherapy for early-stage breast cancer

Purpose To evaluate the efficacy of a psychoeducational intervention in improving cancer-related fatigue. Patients and Methods This randomized controlled trial involved 109 women commencing adjuvant chemotherapy for stage I or II breast cancer in five chemotherapy treatment centers. Intervention group patients received an individualized fatigue education and support program delivered in the clinic and by phone over three 10- to 20-minute sessions 1 week apart. Instruments included a numeric rating scale assessing confidence with managing fatigue; 11-point numeric rating scales measuring fatigue at worst, average, and best; the Functional Assessment of Cancer Therapy-Fatigue and Piper Fatigue Scales; the Cancer Self-Efficacy Scale; the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30; and the Hospital Anxiety and Depression Scale. For each outcome, separate analyses of covariance of change scores between baseline (T1) and the three follow-up time points (T2, T3, and T4) were conducted, controlling for the variable's corresponding baseline value. Results Compared with the intervention group, mean difference scores between the baseline (T1) and immediate after the test (T2) assessments increased significantly more for the control group for worst and average fatigue, Functional Assessment of Cancer Therapy-Fatigue, and Piper fatigue severity and interference measures. These differences were not observed between baseline and T3 and T4 assessments. No significant differences were identified for any pre- or post-test change scores for confidence with managing fatigue, cancer self-efficacy, anxiety, depression, or quality of life. Conclusion Preparatory education and support has the potential to assist women to cope with cancer-related fatigue in the short term. However, further research is needed to identify ways to improve the potency and sustainability of psychoeducational interventions for managing cancer-related fatigue.

A randomized, controlled trial of massage therapy as a treatment for migraine

Background: Migraine is a distressing disorder that is often triggered by stress and poor sleep. Only one randomized controlled trial (RCT) has assessed the effects of massage therapy on migraine experiences, which yielded some promising findings. Purpose: An RCT was designed to replicate and extend the earlier findings using a larger sample, additional stress-related indicators, and assessments past the final session to identify longer-term effects of massage therapy on stress and migraine, experiences. Methods: Migraine sufferers (N = 47) who were randomly assigned to massage or control conditions completed daily assessments of migraine experiences and sleep patterns for 13 weeks. Massage participants attended weekly massage sessions during Weeks 5 to 10. State anxiety, heart rates, and salivary cortisol were assessed before and after the sessions. Perceived stress and coping efficacy were assessed at Weeks 4, 10, and 13. Results: Compared to control participants, massage participants exhibited greater improvements in migraine frequency and sleep quality during the intervention weeks and the 3 follow-up weeks. Trends for beneficial effects of massage therapy on perceived stress and coping efficacy were observed. During sessions, massage induced decreases in state anxiety, heart rate, and cortisol. Conclusions: The findings provide preliminary support for the utility of massage therapy as a nonpharmacologic treatment for individuals suffering from migraines.

Increase in skin cancer screening during a community-based randomized intervention trial

Survival from cutaneous melanoma is mainly dependent on the thickness of the lesion at diagnosis. Skin screening may increase detection of thin lesions and hence improve survival. Within a community-based randomized controlled trial of a population screening program for melanoma in Queensland, Australia, 9 communities were randomly assigned to the 3-year intervention and 9 communities to the control group. Skin screening prevalence was monitored by cross-sectional surveys at baseline, 1, 2 and 3 years into the intervention and 2 years later. At baseline, prevalence of whole-body clinical skin examination was similar in intervention and control communities. In intervention communities, the prevalence of whole-body skin examinations increased to 29.2%, an absolute difference of 18% from baseline, with a peak of 34.8% 2 years after baseline, and began to decline again at the end of the intervention period. The largest increases were seen in men and women ≥50 years. Uptake of screening did not differ according to melanoma risk factors; however, the decline in screening was less in participants who reported a number of melanoma risk factors. The prevalence of skin self-examination remained stable during the intervention program. No changes were observed in the control communities. These results indicate that the intervention program significantly increased the prevalence of whole-body clinical skin examinations in intervention communities. Once the intervention program ceased, and particularly after skin clinics ceased, levels of skin screening began to decline. The provision of specialized skin screening clinics may be needed to achieve sufficient screening rates should population based screening for skin cancer be considered. © 2005 Wiley-Liss, Inc.

Does naltrexone treatment lead to depression? Findings from a randomized controlled trial in subjects with opioid dependence

Objective: Dysphoria and depression have been cited as side effects of the opioid antagonist naltrexone. We aimed to assess whether depressive symptoms are a clinically relevant side effect in a population receiving naltrexone as a treatment for opioid dependence. Methods: We carried out a randomized controlled, open-label trial comparing rapid opiate detoxification under anesthesia and naltrexone treatment with continued methadone maintenance at the Alcohol and Drug Service, Royal Brisbane and Women's Hospital, Brisbane, Australia. The study subjects were patients stabilized on methadone maintenance treatment for heroin dependence who wished to transfer to naltrexone treatment. The Beck Depression Inventory, State-Trait Anxiety Inventory and Opiate Treatment Index subscales for heroin use and social functioning were used at baseline and follow-up assessments at 1, 2, 3 and 6 months. Results: Forty-two participants were allocated to receive naltrexone treatment, whereas 38 continued methadone maintenance as the control condition. Participants who received naltrexone did not exhibit worsening of depressive symptoms. In participants attending all follow-up assessments, there was a trend for those receiving naltrexone to exhibit an improvement in depression over time compared with the control group. Participants who were adherent to naltrexone treatment exhibited fewer depressive symptoms than those who were nonadherent. Conclusions: These results suggest that depression need not be considered a common adverse effect of naltrexone treatment or a treatment contraindication and that engaging with or adhering to naltrexone treatment may be associated with fewer depressive symptoms.

Dapagliflozin monotherapy in drug-naïve patients with diabetes:a randomized-controlled trial of low-dose range

Aims: Many patients with type 2 diabetes are suboptimally managed with currently available therapies. Dapagliflozin, a sodium-glucose co-transporter-2 inhibitor, has shown efficacy in reducing diabetic hyperglycaemia. This study assessed efficacy of three lower doses in recently diagnosed patients. Methods: This phase 3, randomized, double-blind, placebo-controlled study assigned treatment-naïve patients to placebo or dapagliflozin monotherapy (1, 2.5 or 5 mg) daily for 24 weeks. Patients were antidiabetic drug-naïve with inadequate glycaemic control [haemoglobin A1c (HbA1c) =7.0 and =10.0%]. The primary efficacy endpoint was change in HbA1c from baseline. Secondary endpoints included changes in body weight and fasting plasma glucose (FPG), and proportions achieving HbA1c

Physiotherapy for persistent postnatal stress urinary incontinence : a randomized controlled trial

OBJECTIVE: The aim of this study was to compare the effectiveness of multimodal supervised physiotherapy programs with the absence of treatment among women with persistent postnatal stress urinary incontinence. METHODS: This was a single-blind randomized controlled trial. Sixty-four women with stress urinary incontinence were randomly assigned to 8 weeks of either multimodal pelvic floor rehabilitation (n = 21), multimodal pelvic floor rehabilitation with abdominal muscle training (n = 23), or control non–pelvic floor rehabilitation (n = 20). The primary outcome measure consisted of a modified 20-minute pad test. The secondary outcome measures included a Visual Analog Scale describing the perceived burden of incontinence, the Urogenital Distress Inventory, the Incontinence Impact Questionnaire, and pelvic floor muscle function measurements. RESULTS: Two patients dropped out, leaving 62 for analysis. At follow-up, more than 70% of the women in the treatment groups (14/20 in the pelvic floor and 17/23 in the pelvic floor plus abdominal group) were continent on pad testing compared with 0% of women in the control group. Scores on the pad test, Visual Analog Scale, Urogenital Distress Inventory, and Incontinence Impact Questionnaire improved significantly in both treatment groups (all P < .002), whereas no changes were observed in the control group. Pelvic floor muscle function, however, did not improve significantly in either active group. CONCLUSION: Multimodal supervised pelvic floor physiotherapy is an effective treatment for persistent postnatal stress urinary incontinence.

Physiotherapy for persistent postnatal stress urinary incontinence : a randomized controlled trial

OBJECTIVE: The aim of this study was to compare the effectiveness of multimodal supervised physiotherapy programs with the absence of treatment among women with persistent postnatal stress urinary incontinence. METHODS: This was a single-blind randomized controlled trial. Sixty-four women with stress urinary incontinence were randomly assigned to 8 weeks of either multimodal pelvic floor rehabilitation (n = 21), multimodal pelvic floor rehabilitation with abdominal muscle training (n = 23), or control non–pelvic floor rehabilitation (n = 20). The primary outcome measure consisted of a modified 20-minute pad test. The secondary outcome measures included a Visual Analog Scale describing the perceived burden of incontinence, the Urogenital Distress Inventory, the Incontinence Impact Questionnaire, and pelvic floor muscle function measurements. RESULTS: Two patients dropped out, leaving 62 for analysis. At follow-up, more than 70% of the women in the treatment groups (14/20 in the pelvic floor and 17/23 in the pelvic floor plus abdominal group) were continent on pad testing compared with 0% of women in the control group. Scores on the pad test, Visual Analog Scale, Urogenital Distress Inventory, and Incontinence Impact Questionnaire improved significantly in both treatment groups (all P < .002), whereas no changes were observed in the control group. Pelvic floor muscle function, however, did not improve significantly in either active group. CONCLUSION: Multimodal supervised pelvic floor physiotherapy is an effective treatment for persistent postnatal stress urinary incontinence.

A Prospective Randomized Controlled Trial to Study the Impact of a Nutrition-Sensitive Intervention on Adult Women With Cancer Cachexia Undergoing Palliative Care in India

Purpose. Advanced cancer patients with disease progression develop cachexia. Nevertheless, cancer patients at nutritional risk have shown improved body weight and quality of life with oral nutritional supplements. Method. This was a randomized controlled trial in adult female cancer patients (n = 63) attending palliative clinics, with symptoms of cachexia. Eligible patients were randomly distributed into control (n = 33) and intervention (n = 30) groups. Both groups were provided with nutritional and physical activity counseling, but the intervention group received an additional 100 g of Improved Atta (IAtta) for 6 months daily consumption. This study was designed to assess the efficacy of IAtta (with counseling) in enhancing the health status of cachexic patients. Anthropometric measurements, dietary intake, physical activity level and quality of life parameters were assessed at baseline, after 3 months, and at the end of 6 months. Results. Patients in the control group (n = 15) had significantly decreased body weight (P = .003), mid–upper-arm circumference (P = .002), and body fat (P = .002) by the end of intervention. A trend of body weight gain in the intervention group (n = 17; P = .08) and significant increase of body fat (P = .002) was observed; moreover, patients reported a significant improvement in fatigue (P = .002) and appetite scores (P = .006) under quality-of-life domains at the end of intervention. Conclusions. Embedding a nutrition-sensitive intervention ( IAtta ) within Indian palliative care therapy may improve quality of life and stabilize body weight in cancer cachexia patients.

A randomized controlled trial of an early-intervention, computer-based literacy program to boost phonological skills in 4- to 6-year-old children

Background: Many school-based interventions are being delivered in the absence of evidence of effectiveness (Snowling & Hulme, 2011, Br. J. Educ. Psychol., 81, 1).Aim: This study sought to address this oversight by evaluating the effectiveness of the commonly used the Lexia Reading Core5 intervention, with 4- to 6-year-old pupils in Northern Ireland.Sample: A total of 126 primary school pupils in year 1 and year 2 were screened on the Phonological Assessment Battery 2nd Edition (PhAB-2). Children were recruited from the equivalent year groups to Reception and Year 1 in England and Wales, and Pre-kindergarten and Kindergarten in North America.
Methods: A total of 98 below-average pupils were randomized (T0) to either an 8-week block (inline image = 647.51 min, SD = 158.21) of daily access to Lexia Reading Core5 (n = 49) or a waiting-list control group (n = 49). Assessment of phonological skills was completed at post-intervention (T1) and at 2-month follow-up (T2) for the intervention group only.
Results: Analysis of covariance which controlled for baseline scores found that the Lexia Reading Core5 intervention group made significantly greater gains in blending, F(1, 95) = 6.50, p = .012, partial η2 = .064 (small effect size) and non-word reading, F(1, 95) = 7.20, p = .009, partial η2 = .070 (small effect size). Analysis of the 2-month follow-up of the intervention group found that all group treatment gains were maintained. However, improvements were not uniform among the intervention group with 35% failing to make progress despite access to support. Post-hoc analysis revealed that higher T0 phonological working memory scores predicted improvements made in phonological skills.
Conclusions: An early-intervention, computer-based literacy program can be effective in boosting the phonological skills of 4- to 6-year-olds, particularly if these literacy difficulties are not linked to phonological working memory deficits.

Interventions to Promote Follow-up After Trabeculectomy Surgery in Rural Southern China: A Randomized Clinical Trial.

Importance:

Follow-up after trabeculectomy surgery is important to surgical success, but little is known about the effect of interventions on improving follow-up in low-resource areas.

Objective:

To examine whether text message reminders and free eye medications improve follow-up after trabeculectomy in rural southern China.

Design, Setting, and Participants:

This randomized clinical trial studied 222 consecutive patients undergoing trabeculectomy from October 1, 2014, through November 31, 2015, at 4 rural hospitals in Guangdong and Guangxi Provinces, China. Data from the intention-to-treat population were analyzed.

Interventions:

Patients undergoing trabeculectomy were randomized (1:1) to receive text message reminders 3 days before appointments at 1 and 2 weeks and 1 month after surgery and free topical corticosteroid medication (US$5.30) at each visit or to standard follow-up without reminders or free medication.

Main Outcomes and Measure:

Follow-up at 1 month postoperatively.

Results:

Among 222 eligible patients, 13 (5.9%) refused and 209 (94.1%) were enrolled, with 106 (50.7%) randomized to the intervention group (mean [SD] age, 64.4 [12.7] years; 56 women [52.8%]) and 103 (49.3%) to the control group (mean [SD] age, 63.0 [12.7] years; 53 women [51.5%]). A total of 6 patients (2.9%) were unavailable for follow-up. Attendance at 1 month for the intervention group (59 of 102 [57.8%]) was significantly higher than for the control group (34 of 101 [33.7%]) (unadjusted relative risk [RR], 1.72; 95% CI, 1.13-2.63; P = .01). Factors associated with 1-month attendance in multiple regression models included intervention group membership (RR, 1.65; 95% CI, 1.08-2.53; P = .02) and being told to return for suture removal (RR, 1.80; 95% CI, 1.06-3.06; P = .03). One-month attendance among controls not told about suture removal was 3 of 31 (9.7%), whereas it was 44 of 68 (64.7%) among the intervention group with suture removal (unadjusted RR, 6.69; 95% CI, 2.08-21.6; P = .001).

Conclusions and Relevance:

In this setting, low-cost interventions may significantly improve postoperative follow-up after glaucoma surgery, a potential opportunity for interventions known to improve surgical success.

Amphetamine increases blood pressure and heart rate but has no effect on motor recovery or cerebral haemodynamics in ischaemic stroke: a randomized controlled trial (ISRCTN 36285333)

Amphetamine enhances recovery after experimental ischaemia and has shown promise in small clinical trials when combined with motor or sensory stimulation. Amphetamine, a sympathomimetic, might have haemodynamic effects in stroke patients, although limited data have been published. Subjects were recruited 3-30 days post ischaemic stroke into a phase II randomised (1:1), double blind, placebo-controlled trial. Subjects received dexamphetamine (5mg initially, then 10mg for 10 subsequent doses with 3 or 4 day separations) or placebo in addition to inpatient physiotherapy. Recovery was assessed by motor scales (Fugl-Meyer, FM), and functional scales (Barthel index, BI and modified Rankin score, mRS). Peripheral blood pressure (BP), central haemodynamics and middle cerebral artery blood flow velocity were assessed before, and 90 minutes after, the first 2 doses. 33 subjects were recruited, age 33-88 (mean 71) years, males 52%, 4-30 (median 15) days post stroke to inclusion. 16 patients were randomised to placebo and 17 amphetamine. Amphetamine did not improve motor function at 90 days; mean (standard deviation) FM 37.6 (27.6) vs. control 35.2 (27.8) (p=0.81). Functional outcome (BI, mRS) did not differ between treatment groups. Peripheral and central systolic BP, and heart rate, were 11.2 mmHg (p=0.03), 9.5 mmHg (p=0.04) and 7 beats/minute (p=0.02) higher respectively with amphetamine, compared with control. A non-significant reduction in myocardial perfusion (Buckberg Index) was seen with amphetamine. Other cardiac and cerebral haemodynamics were unaffected. Amphetamine did not improve motor impairment or function after ischaemic stroke but did significantly increase BP and heart rate without altering cerebral haemodynamics.

Efficacy of early skin-to-skin contact on the rate of exclusive breastfeeding in term neonates: a randomized controlled trial

Background: Despite multiple benefits of breast milk, the rates of exclusive breastfeeding in developing countries are low. Objective: To evaluate the efficacy of early skin -to -skin contact (SSC) on the rate of exclusive breastfeeding (EBF) at 6 weeks of age among term neonates born by vaginal delivery. Methods: Term neonates born by vaginal delivery and did not require any resuscitation were randomized at birth to SSC (n=100) and control (n=100) group. Immediately after clamping the umbilical cord, SSC group neonates were placed on the bare bosom of mother and control group neonates were placed under a radiant warmer for a period of 45 minutes each while mothers underwent management of the third stage of labor and episiotomy repair. Pain experienced by mother during episiotomy repair was recorded using a numerical pain scale The primary outcome evaluated was the rate of exclusive breastfeeding at 6 weeks of postnatal age. Results: A significantly higher proportion of neonates were exclusively breastfeed at 6 weeks of age in the SSC group than in the control group (72% vs. 57.6%, p=0.04, relative risk: 1.3, 95% confidence interval: 1.0 -1.6). The pain score during episiotomy repair in mothers of the SSC group was significantly lower than the control group (4.74±0.85 versus 5.34±0.81; P <0.01). Conclusions: Early SSC significantly improved the rate of exclusively breastfeeding at 6 weeks of age among healthy term neonates. An important additional effect was a decrease in the amount of pain that mothers in the SSC group experienced during episiotomy repair.