Evidence Of Between-group Differences Research Articles

Effect of a multicomponent quality improvement strategy on sustained achievement of diabetes care goals and macrovascular and microvascular complications in South Asia at 6.5 years follow-up: Post hoc analyses of the CARRS randomized clinical trial.

Diabetes control is poor globally and leads to burdensome microvascular and macrovascular complications. We aimed to assess post hoc between-group differences in sustained risk factor control and macrovascular and microvascular endpoints at 6.5 years in the Center for cArdiovascular Risk Reduction in South Asia (CARRS) randomized trial. This parallel group individual randomized clinical trial was performed at 10 outpatient diabetes clinics in India and Pakistan from January 2011 through September 2019. A total of 1,146 patients with poorly controlled type 2 diabetes (HbA1c ≥8% and systolic BP ≥140 mm Hg and/or LDL-cholesterol ≥130 mg/dL) were randomized to a multicomponent quality improvement (QI) strategy (trained nonphysician care coordinator to facilitate care for patients and clinical decision support system for physicians) or usual care. At 2.5 years, compared to usual care, those receiving the QI strategy were significantly more likely to achieve multiple risk factor control. Six clinics continued, while 4 clinics discontinued implementing the QI strategy for an additional 4-year follow-up (overall median 6.5 years follow-up). In this post hoc analysis, using intention-to-treat, we examined between-group differences in multiple risk factor control (HbA1c <7% plus BP <130/80 mm Hg and/or LDL-cholesterol <100 mg/dL) and first macrovascular endpoints (nonfatal myocardial infarction, nonfatal stroke, death, revascularization [angioplasty or coronary artery bypass graft]), which were co-primary outcomes. We also examined secondary outcomes, namely, single risk factor control, first microvascular endpoints (retinopathy, nephropathy, neuropathy), and composite first macrovascular plus microvascular events (which also included amputation and all-cause mortality) by treatment group and whether QI strategy implementation was continued over 6.5 years. At 6.5 years, assessment data were available for 854 participants (74.5%; n = 417 [intervention]; n = 437 [usual care]). In terms of sociodemographic and clinical characteristics, participants in the intervention and usual care groups were similar and participants at sites that continued were no different to participants at sites that discontinued intervention implementation. Patients in the intervention arm were more likely to exhibit sustained multiple risk factor control than usual care (relative risk: 1.77; 95% confidence interval [CI], 1.45, 2.16), p < 0.001. Cumulatively, there were 233 (40.5%) first microvascular and macrovascular events in intervention and 274 (48.0%) in usual care patients (absolute risk reduction: 7.5% [95% CI: -13.2, -1.7], p = 0.01; hazard ratio [HR] = 0.72 [95% CI: 0.61, 0.86]), p < 0.001. Patients in the intervention arm experienced lower incidence of first microvascular endpoints (HR = 0.68 [95% CI: 0.56, 0.83), p < 0.001, but there was no evidence of between-group differences in first macrovascular events. Beneficial effects on microvascular and composite vascular outcomes were observed in sites that continued, but not sites that discontinued the intervention. In urban South Asian clinics, a multicomponent QI strategy led to sustained multiple risk factor control and between-group differences in microvascular, but not macrovascular, endpoints. Between-group reductions in vascular outcomes at 6.5 years were observed only at sites that continued the QI intervention, suggesting that practice change needs to be maintained for better population health of people with diabetes. ClinicalTrials.gov NCT01212328.

Flat flexible compared to stable supportive footwear for self-managing knee osteoarthritis symptoms: a randomised clinical trial

Introduction: International clinical guidelines advise stable supportive shoes for knee osteoarthritis (OA) however evidence suggests flat flexible shoes may reduce knee joint loading and symptoms. We hypothesised that flat flexible shoes would lead to greater improvements in pain and function, compared to stable supportive shoes. Methods: This was a two-arm, participant- and assessor-blinded comparative effectiveness randomised controlled trial. We recruited 164 people aged 50 years or older with knee pain on most days of the past month and moderate to severe radiographic medial tibiofemoral OA. Participants were randomised to receive either flat flexible shoes (n=82) or stable supportive shoes (n=82), classified based on: i) differences in shoe heel height/thickness, ii) shoe pitch, iii) arch support/motion control features, iv) sole flexibility and v) weight. Shoes were worn >6 hours/day for 6 months. Primary outcomes were changes in walking knee pain (11-point numerical rating scale) and physical function (Western Ontario and McMaster Universities Osteoarthritis Index subscale, 0-68) at 6-months. Secondary outcomes included additional measures of pain, function, physical activity, quality of life and adverse events. Results: 164 participants were recruited and 161 (98%) completed 6-month primary outcomes. There was evidence of a between-group difference in change in walking knee pain favoring stable supportive shoes (mean difference=1.1 units (95%CI 0.5 to 1.8; p=0.001) but no strong evidence of difference in function (2.3 (-0.9 to 5.5; p=0.17)). Furthermore, 46 (58%) participants in the stable supportive group achieved the minimal clinically important difference (MCID) in pain, compared to 32 (40%) in the flat flexible group (relative risk 1.56, 1.05 to 2.02). Improvements in knee-related quality of life and ipsilateral hip pain also favored stable supportive shoes (-5.3 (-10.0 to -0.5; p=0.03) and 0.7 (0.0 to 1.4; p=0.04), respectively), with no evidence of between-group differences in other secondary outcomes. Fewer participants reported adverse events with stable supportive shoes (n=12 (15%)) compared to flat flexible shoes (n=26 (32%); relative risk=0.46 (0.25 to 0.84; p=0.012)). Discussion: Flat flexible shoes were not superior to stable supportive shoes. Contrary to our hypothesis, stable supportive shoes improved knee pain on walking more than flat flexible shoes. Furthermore, a greater proportion of participants allocated to stable supportive shoes achieved the MCID in walking pain compared to those allocated to flat flexible shoes. Findings from this trial are the first to show that stable supportive shoes may be an inexpensive, low burden self-management strategy to improve pain associated with knee OA. Conflict of interest statement: My co-authors and I acknowledge that we have no conflict of interest of relevance to the submission of this abstract

Quantifying the overall impact of an early childhood multi-behavioural lifestyle intervention.

The overall impact of interventions targeting multiple behaviours remains largely unexplored. This study adopted an integrative lifestyle pattern analysis approach to assess the overall effectiveness of an early childhood intervention on change across multiple behaviours. The Melbourne INFANT program was a 15-month cluster-randomized controlled trial involving 4-month-old infants and their parents at baseline in 2008 (n=542). The intervention included six education sessions helping parents to promote a healthy diet, physical activity and limit sedentary behaviour in their infants. Participants were followed-up twice post-intervention, at ages 3.6 (2011) and 5 years (2013), to assess sustained effects of the intervention. Previous principal component analyses identified two lifestyle patterns from dietary intake, outdoor time and television viewing time. Random effect linear regression models were conducted to assess the impact of the intervention on lifestyle patterns. The intervention group had a lower 'Discretionary consumption and TV' lifestyle pattern score than the control group at all time points with adjusted mean difference: -0.29, 95% CI -0.49, -0.09, p=0.004 post-intervention at age 1.5 years; -0.29, 95% CI -0.54, -0.04, p=0.02 at the first follow-up (age 3.6 years); and -0.21, 95% CI -0.43, 0.01, p=0.06 at the second follow-up (age 5.0 years). No evidence of between-group differences was found for the 'Fruit, vegetables and outdoor' lifestyle pattern score. This early childhood intervention designed to promote change in more than one obesity-related behaviour was effective in improving correlated unhealthy lifestyle behaviours. Lifestyle pattern analysis is a useful and interpretable approach for evaluating multi-behavioural interventions.

Behavior Change Text Messages for Home Exercise Adherence in Knee Osteoarthritis: Randomized Trial.

BackgroundExercise is a core recommended treatment for knee osteoarthritis (OA), yet adherence declines, particularly following cessation of clinician supervision.ObjectiveThis study aims to evaluate whether a 24-week SMS intervention improves adherence to unsupervised home exercise in people with knee OA and obesity compared with no SMS.MethodsA two-group superiority randomized controlled trial was performed in a community setting. Participants were people aged 50 years with knee OA and BMI ≥30 kg/m2 who had undertaken a 12-week physiotherapist-supervised exercise program as part of a preceding clinical trial. Both groups were asked to continue their home exercise program unsupervised three times per week for 24 weeks and were randomly allocated to a behavior change theory–informed, automated, semi-interactive SMS intervention addressing exercise barriers and facilitators or to control (no SMS). Primary outcomes were self-reported home exercise adherence at 24 weeks measured by the Exercise Adherence Rating Scale (EARS) Section B (0-24, higher number indicating greater adherence) and the number of days exercised in the past week (0-3). Secondary outcomes included self-rated adherence (numeric rating scale), knee pain, physical function, quality of life, global change, physical activity, self-efficacy, pain catastrophizing, and kinesiophobia.ResultsA total of 110 participants (56 SMS group and 54 no SMS) were enrolled and 99 (90.0%) completed both primary outcomes (48/56, 86% SMS group and 51/54, 94% no SMS). At 24 weeks, the SMS group reported higher EARS scores (mean 16.5, SD 6.5 vs mean 13.3, SD 7.0; mean difference 3.1, 95% CI 0.8-5.5; P=.01) and more days exercised in the past week (mean 1.8, SD 1.2 vs mean 1.3, SD 1.2; mean difference 0.6, 95% CI 0.2-1.0; P=.01) than the control group. There was no evidence of between-group differences in secondary outcomes.ConclusionsAn SMS program increased self-reported adherence to unsupervised home exercise in people with knee OA and obesity, although this did not translate into improved clinical outcomes.Trial RegistrationAustralian New Zealand Clinical Trials Registry 12617001243303; https://tinyurl.com/y2ud7on5International Registered Report Identifier (IRRID)RR2-10.1186/s12891-019-2801-z

Progressive resistance training for adolescents with cerebral palsy: the STAR randomized controlled trial.

To evaluate the effect of progressive resistance training of the ankle plantarflexors on gait efficiency, activity, and participation in adolescents with cerebral palsy (CP). Sixty-four adolescents (10-19y; 27 females, 37 males; Gross Motor Function Classification System [GMFCS] levels I-III) were randomized to 30 sessions of resistance training (10 supervised and 20 unsupervised home sessions) over 10 weeks or usual care. The primary outcome was gait efficiency indicated by net nondimensional oxygen cost (NNcost). Secondary outcomes included physical activity, gross motor function, participation, muscle strength, muscle and tendon size, and muscle and tendon stiffness. Analysis was intention-to-treat. Median attendance at the 10 supervised sessions was 80% (range 40-100%). There was no between-group difference in NNcost at 10 (mean difference: 0.02, 95% confidence interval [CI] -0.07 to 0.11, p=0.696) or 22 weeks (mean difference: -0.08, 95% CI -0.18 to 0.03, p=0.158). There was also no evidence of between-group differences in secondary outcomes at 10 or 22 weeks. There were 123 adverse events reported by 27 participants in the resistance training group. We found that 10 supervised sessions and 20 home sessions of progressive resistance training of the ankle plantarflexors did not improve gait efficiency, muscle strength, activity, participation, or any biomechanical outcome among adolescents with CP. Thirty sessions of progressive resistance training of the ankle plantarflexors over 10 weeks did not improve gait efficiency among ambulatory adolescents with cerebral palsy. Resistance training did not improve muscle strength, activity, or participation. Ninety percent of participants experienced an adverse event. Most adverse events were expected and no serious adverse events were reported.

Vitamin A and fish oils for preventing the progression of retinitis pigmentosa.

Vitamin A and fish oils for preventing the progression of retinitis pigmentosa.

Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy

Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy

A Prospective, randomized comparative study between ultrasound-guided posterior quadratus lumborum block and ultrasound-guided ilioinguinal/iliohypogastric nerve block for pediatric inguinal herniotomy.

Ilioinguinal/iliohypogastric nerve block is commonly performed to control postherniotomy pain. The posterior quadratus lumborum block has been recently described as an effective analgesic technique for pediatric low abdominal surgery. No data were found regarding the use of posterior quadratus lumborum block in comparison with the traditional ilioinguinal/iliohypogastric nerve block in pediatric inguinal surgery. This randomized assessor-blinded study compared postoperative analgesic effects between ultrasound-guided posterior quadratus lumborum block and ilioinguinal/iliohypogastric nerve block in pediatric inguinal herniotomy. One- to seven-year-old children scheduled for unilateral open herniotomy were randomly assigned to receive either ultrasound-guided posterior quadratus lumborum block with 0.25% bupivacaine 0.5mL/kg or ultrasound-guided ilioinguinal/iliohypogastric nerve block with 0.25% bupivacaine 0.2mL/kg after induction of general anesthesia. The primary outcome was the proportion of patients who received postoperative oral acetaminophen. The required fentanyl in the recovery room, 24-hour acetaminophen consumption, success rate of regional blocks, block performance data, block-related complications, postoperative pain intensity, and parental satisfaction were assessed. This study included 40 patients after excluding four cases who were ineligible. The number of patients who required postoperative oral acetaminophen was significantly lower in the posterior quadratus lumborum block group (15.8% vs 52.6%; OR: 5.9; 95% CI: 1.3, 27.3; P=.022). The pain scores at 30minutes, 1, 2, 6, 12, and 24hours were similar between groups. There was no evidence of between-group differences in block performance time, the number of needle passes, block-related complications, and parental satisfaction. The posterior quadratus lumborum block with 0.25% bupivacaine 0.5mL/kg provided better pain control than the ilioinguinal/iliohypogastric nerve block with 0.25% bupivacaine 0.2mL/kg after open herniotomy in children. The ultrasound guidance technique for the posterior quadratus lumborum block is safe and as simple as the ultrasound-guided ilioinguinal/iliohypogastric nerve block for pediatric patients.

Immediate Transfusion in African Children with Uncomplicated Severe Anemia

BackgroundThe World Health Organization recommends not performing transfusions in African children hospitalized for uncomplicated severe anemia (hemoglobin level of 4 to 6 g per deciliter and no signs of clinical severity). However, high mortality and readmission rates suggest that less restrictive transfusion strategies might improve outcomes.MethodsIn this factorial, open-label, randomized, controlled trial, we assigned Ugandan and Malawian children 2 months to 12 years of age with uncomplicated severe anemia to immediate transfusion with 20 ml or 30 ml of whole-blood equivalent per kilogram of body weight, as determined in a second simultaneous randomization, or no immediate transfusion (control group), in which transfusion with 20 ml of whole-blood equivalent per kilogram was triggered by new signs of clinical severity or a drop in hemoglobin to below 4 g per deciliter. The primary outcome was 28-day mortality. Three other randomizations investigated transfusion volume, postdischarge supplementation with micronutrients, and postdischarge prophylaxis with trimethoprim–sulfamethoxazole.ResultsA total of 1565 children (median age, 26 months) underwent randomization, with 778 assigned to the immediate-transfusion group and 787 to the control group; 984 children (62.9%) had malaria. The children were followed for 180 days, and 71 (4.5%) were lost to follow-up. During the primary hospitalization, transfusion was performed in all the children in the immediate-transfusion group and in 386 (49.0%) in the control group (median time to transfusion, 1.3 hours vs. 24.9 hours after randomization). The mean (±SD) total blood volume transfused per child was 314±228 ml in the immediate-transfusion group and 142±224 ml in the control group. Death had occurred by 28 days in 7 children (0.9%) in the immediate-transfusion group and in 13 (1.7%) in the control group (hazard ratio, 0.54; 95% confidence interval [CI], 0.22 to 1.36; P=0.19) and by 180 days in 35 (4.5%) and 47 (6.0%), respectively (hazard ratio, 0.75; 95% CI, 0.48 to 1.15), without evidence of interaction with other randomizations (P>0.20) or evidence of between-group differences in readmissions, serious adverse events, or hemoglobin recovery at 180 days. The mean length of hospital stay was 0.9 days longer in the control group.ConclusionsThere was no evidence of differences in clinical outcomes over 6 months between the children who received immediate transfusion and those who did not. The triggered-transfusion strategy in the control group resulted in lower blood use; however, the length of hospital stay was longer, and this strategy required clinical and hemoglobin monitoring. (Funded by the Medical Research Council and Department for International Development; TRACT Current Controlled Trials number, ISRCTN84086586.)

Effect of cane use on bone marrow lesion volume in people with medial tibiofemoral knee osteoarthritis: randomized clinical trial

To evaluate effects of daily cane use for 3 months on medial tibiofemoral bone marrow lesion (BML) volumes in people with medial tibiofemoral osteoarthritis (OA). In this randomized controlled trial (RCT), 79 participants with medial tibiofemoral OA were randomized to either a cane group (using a cane whenever walking) or control group (not using any gait aid) for 3 months. The cane group received a single training session by a physiotherapist, using a biofeedback cane to teach optimal technique and body weight support and motor learning principles to facilitate retention of learning. The primary outcome was change in total medial tibiofemoral BML volume (per unit bone volume) measured from magnetic resonance imaging (MRI) at 3 months. Secondary outcomes were BML volumes (per unit bone volume) of the medial tibia and femur, and patient-reported outcomes of overall knee pain, knee pain on walking, physical function, perceived global symptom changes and health-related quality of life. MRI analyses were performed by a blinded assessor. Seventy-eight participants (99%) completed the primary outcome. Mean (standard deviation) daily cane use was 2.3 (1.7) hours over 3 months. No evidence of between-group differences was found for change in total medial tibiofemoral BML volume (mean difference:-0.0010 (95% confidence intervals:-0.0022, 0.0003)). Most secondary outcomes showed minimal differences between groups. Daily use of a cane during walking for 3 months aiming to reduce knee joint loading did not change medial tibiofemoral BML volumes compared to no use of gait aids. Australian New Zealand Clinical Trial Registry (ACTRN12614000909628).

Anticipatory Effects on Perceived Pain: Associations With Development and Anxiety.

Naturalistic studies suggest that expectation of adverse experiences such as pain exerts particularly strong effects on anxious youth. In healthy adults, expectation influences the experience of pain. The current study uses experimental methods to compare the effects of expectation on pain among adults, healthy youth, and youth with an anxiety disorder. Twenty-three healthy adults, 20 healthy youth, and 20 youth with an anxiety disorder underwent procedures in which auditory cues were paired with noxious thermal stimulation. Through instructed conditioning, one cue predicted low-pain stimulation and the other predicted high-pain stimulation. At test, each cue was additionally followed by a single temperature calibrated to elicit medium pain ratings. We compared cue-based expectancy effects on pain across the three groups, based on cue effects on pain elicited on medium heat trials. Across all groups, as expected, participants reported greater pain with increasing heat intensity (β = 2.29, t(41) = 29.94, p < .001). Across all groups, the critical medium temperature trials were rated as more painful in the high- relative to low-expectancy condition (β = 1.72, t(41) = 10.48, p < .001). However, no evidence of between-group differences or continuous associations with age or anxiety was observed. All participants showed strong effects of expectancy on pain. No influences of development or anxiety arose. Complex factors may influence associations among anxiety, development, and pain reports in naturalistic studies. Such factors may be identified using experiments that employ more complex, yet controlled manipulations of expectancy or assess neural correlates of expectancy.