Versus Usual Care Research Articles

TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE): protocol for a cluster-randomised clinical trial on adult general ICUs in Brazil

IntroductionDaily multidisciplinary rounds (DMRs) consist of systematic patient-centred discussions aiming to establish joint therapeutic goals for the next 24 hours of intensive care unit (ICU) care. The aim of the...

Machine Learning Versus Usual Care for Diagnostic and Prognostic Prediction in the Emergency Department: A Systematic Review.

Having shown promise in other medical fields, we sought to determine whether machine learning (ML) models perform better than usual care in diagnostic and prognostic prediction for emergency department (ED) patients. In this systematic review, we searched MEDLINE, Embase, Central, and CINAHL from inception to October 17, 2019. We included studies comparing diagnostic and prognostic prediction of ED patients by ML models to usual care methods (triage-based scores, clinical prediction tools, clinician judgment) using predictor variables readily available to ED clinicians. We extracted commonly reported performance metrics of model discrimination and classification. We used the PROBAST tool for risk of bias assessment (PROSPERO registration: CRD42020158129). The search yielded 1,656 unique records, of which 23 studies involving 16,274,647 patients were included. In all seven diagnostic studies, ML models outperformed usual care in all performance metrics. In six studies assessing in-hospital mortality, the best-performing ML models had better discrimination (area under the receiver operating characteristic curve [AUROC]=0.74-0.94) than any clinical decision tool (AUROC=0.68-0.81). In four studies assessing hospitalization, ML models had better discrimination (AUROC=0.80-0.83) than triage-based scores (AUROC=0.68-0.82). Clinical heterogeneity precluded meta-analysis. Most studies had high risk of bias due to lack of external validation, low event rates, and insufficient reporting of calibration. Our review suggests that ML may have better prediction performance than usual care for ED patients with a variety of clinical presentations and outcomes. However, prediction model reporting guidelines should be followed to provide clinically applicable data. Interventional trials are needed to assess the impact of ML models on patient-centered outcomes.

Effectiveness of a Group-Based Lifestyle Change Program Versus Usual Care: An Electronic Health Record, Propensity Score–Matched Cohort Study

Translational lifestyle change programs for community and clinical settings have been available for a decade, yet there are limited data on their comparative effectiveness. This study examines the effectiveness of a Centers for Disease Control and Prevention-aligned lifestyle change program relative to usual care in clinical practice. This was an electronic health record-based retrospective cohort study conducted in a community-based healthcare system. Investigators identified adult program participants and usual-care patients in the electronic health record between 2010 and 2018 and defined their index date (baseline) as the first lifestyle change program encounter or a random encounter date, respectively. Participants were matched 1:2 to usual-care patients on baseline demographics and clinical characteristics using propensity-score methods. Changes in body weight and blood pressure were examined from baseline through 24 months. The authors identified 2,833 program participants and 438,432 usual-care patients meeting study eligibility criteria. A total of 2,833 program participants were matched to 4,776 usual-care patients; the average age was 54 years, and 80% of the participants were female. Program participation was associated with a 1.9- and 1.6-fold higher prevalence of clinically meaningful (≥5%) weight loss at 12- and 24-month follow-up than usual care and a higher prevalence of blood pressure control at 12 months but not at 24 months. Patients without type 2 diabetes at baseline had more pronounced outcomes than those with type 2 diabetes. This study demonstrates the effectiveness of an evidence-based, Centers for Disease Control and Prevention-aligned lifestyle change program in reducing cardiometabolic risk factors compared with usual care in clinical practice, with long-term reductions in weight and transient reductions in blood pressure.

Randomized Comparison of Exercise Intervention Versus Usual Care in Older Adult Patients with Frailty After Acute Myocardial Infarction

BackgroundOlder adult patients with frailty are rarely involved in rehabilitation programs after myocardial infarction. Our aim was to investigate the benefits of exercise intervention in these patients. MethodsA total of 150 survivors after acute myocardial infarction, ≥70 years and with pre-frailty or frailty (Fried scale ≥1 points), were randomized to control (n = 77) or intervention (n = 73) groups. The intervention consisted of a 3-month exercise program, under physiotherapist supervision, followed by an independent home-based program. The main outcome was frailty (Fried scale) at 3 months and 1 year. Secondary endpoints were clinical events (mortality or any readmission) at 1 year. ResultsMean age was 80 years (range = 70-96). In the intervention group, 44 (60%) out of 73 patients participated in the program and 23 (32%) completed it. Overall, there was a decrease in the Fried score in the intervention group at 3 months, with no effect at 1 year. However, in the intention-to-treat analysis, such change did not achieve statistical significance (P = 0.110). Only treatment comparisons made among the subgroups that participated in (P = 0.033) and completed (P = 0.018) the program achieved statistical significance. There were no differences in clinical events. Worse Fried score trajectory along follow-up increased mortality risk (hazard ratio [HR] = 2.38, 95% confidence interval [CI] 1.24-4.55, P = 0.009) ConclusionsRecruitment and retention for a physical program in older adult patients with frailty after myocardial infarction was challenging. Frailty status improved in the subgroup that participated in the program, although this benefit was attenuated after shifting to a home-based program. A better frailty trajectory might influence midterm prognosis. (ClinicalTrials.govNCT02715453).

Cost-effectiveness of Restrictive Strategy Versus Usual Care for Cholecystectomy in Patients With Gallstones and Abdominal Pain (SECURE-trial).

To perform a cost-effectiveness analysis of restrictive strategy versus usual care in patients with gallstones and abdominal pain. A restrictive selection strategy for surgery in patients with gallstones reduces cholecystectomies, but the impact on overall costs and cost-effectiveness is unknown. Data of a multicentre, randomized-controlled trial (SECURE-trial) were used. Adult patients with gallstones and abdominal pain were included. Restrictive strategy was economically evaluated against usual care from a societal perspective. Hospital-use of resources was gathered with case-report forms and out-of-hospital consultations, out-of-pocket expenses, and productivity loss were collected with questionnaires. National unit costing was applied. The primary outcome was the cost per pain-free patient after 12 months. All 1067 randomized patients (49.0 years, 73.7% females) were included. After 12 months, 56.2% of patients were pain-free in restrictive strategy versus 59.8% after usual care. The restrictive strategy significantly reduced the cholecystectomy rate with 7.7% and reduced surgical costs with €160 per patient, €162 was saved from a societal perspective. The cost-effectiveness plane showed that restrictive strategy was cost saving in 89.1%, but resulted in less pain-free patients in 88.5%. Overall, the restrictive strategy saved €4563 from a societal perspective per pain-free patient lost. A restrictive selection strategy for cholecystectomy saves €162 compared to usual care, but results in fewer pain-free patients. The incremental cost per pain-free patient are savings of €4563 per pain-free patient lost. The higher societal willingness to pay for 1 extra pain-free patient, the lower the probability that the restrictive strategy will be cost-effective. The Netherlands National Trial Register NTR4022. Registered on 5 June 2013.

Bayesian Regression Model for a Cost-Utility and Cost-Effectiveness Analysis Comparing Punch Grafting Versus Usual Care for the Treatment of Chronic Wounds.

Punch grafting is a traditional technique used to promote epithelialization of hard-to-heal wounds. The main purpose of this observational study was to conduct a cost-utility analysis (CUA) and a cost-effectiveness analysis (CEA) comparing punch grafting (n = 46) with usual care (n = 34) for the treatment of chronic wounds in an outpatient specialized wound clinic from a public healthcare system perspective (Spanish National Health system) with a three-month time horizon. CUA outcome was quality-adjusted life years (QALYs) calculated from EuroQoL-5D, whereas CEA outcome was wound-free period. One-way sensitivity analyses, extreme scenario analysis, and re-analysis by subgroups were conducted to fight against uncertainty. Bayesian regression models were built to explore whether differences between groups in costs, wound-free period, and QALYs could be explained by other variables different to treatment. As main results, punch grafting was associated with a reduction of 37% in costs compared to usual care, whereas mean incremental utility (0.02 ± 0.03 QALYs) and mean incremental effectiveness (7.18 ± 5.30 days free of wound) were favorable to punch grafting. All sensitivity analyses proved the robustness of our models. To conclude, punch grafting is the dominant alternative over usual care because it is cheaper and its utility and effectiveness are greater.

The Effect of High Protein and Early Resistance Exercise Versus Usual Care in Critically Ill Patients (EFFORT-X Trial)

The Effect of High Protein and Early Resistance Exercise Versus Usual Care in Critically Ill Patients (EFFORT-X Trial)

Smartphone Cardiac Rehabilitation, Assisted Self-Management Versus Usual Care: Protocol for a Multicenter Randomized Controlled Trial to Compare Effects and Costs Among People With Coronary Heart Disease.

BackgroundAlternative evidence-based cardiac rehabilitation (CR) delivery models that overcome significant barriers to access and delivery are needed to address persistent low utilization. Models utilizing contemporary digital technologies could significantly improve reach and fidelity as complementary alternatives to traditional center-based programs.ObjectiveThe aim of this study is to compare the effects and costs of the innovative Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) intervention with usual care CR.MethodsIn this investigator-, assessor-, and statistician-blinded parallel 2-arm randomized controlled trial, 220 adults (18+ years) with coronary heart disease are being recruited from 3 hospitals in metropolitan and regional Victoria, Australia. Participants are randomized (1:1) to receive advice to engage with usual care CR or the SCRAM intervention. SCRAM is a 24-week dual-phase intervention that includes 12 weeks of real-time remote exercise supervision and coaching from exercise physiologists, which is followed by 12 weeks of data-driven nonreal-time remote coaching via telephone. Both intervention phases include evidence- and theory-based multifactorial behavior change support delivered via smartphone push notifications. Outcomes assessed at baseline, 12 weeks, and 24 weeks include maximal aerobic exercise capacity (primary outcome at 24 weeks), modifiable cardiovascular risk factors, exercise adherence, secondary prevention self-management behaviors, health-related quality of life, and adverse events. Economic and process evaluations will determine cost-effectiveness and participant perceptions of the treatment arms, respectively.ResultsThe trial was funded in November 2017 and received ethical approval in June 2018. Recruitment began in November 2018. As of September 2019, 54 participants have been randomized into the trial.ConclusionsThe innovative multiphase SCRAM intervention delivers real-time remote exercise supervision and evidence-based self-management behavioral support to participants, regardless of their geographic proximity to traditional center-based CR facilities. Our trial will provide unique and valuable information about effects of SCRAM on outcomes associated with cardiac and all-cause mortality, as well as acceptability and cost-effectiveness. These findings will be important to inform health care providers about the potential for innovative program delivery models, such as SCRAM, to be implemented at scale, as a complement to existing CR programs. The inclusion of a cohort comprising metropolitan-, regional-, and rural-dwelling participants will help to understand the role of this delivery model across health care contexts with diverse needs.Trial RegistrationAustralian New Zealand Clinical Trials Registry (ACTRN): 12618001458224; anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374508.International Registered Report Identifier (IRRID)DERR1-10.2196/15022

A Prospective Randomized Trial of an Oral Patient-Controlled Analgesia Device Versus Usual Care Following Total Hip Arthroplasty.

Multimodal pain management for surgery patients may include the use of a combination of scheduled oral pain medications with as-needed (PRN) oral opioids. Multiple concurrent time demands on nursing staff frequently cause delays in the delivery of oral PRN pain medication compromising pain management. Postoperative pain control was compared using a wireless oral patient-controlled analgesia device for the delivery of oxycodone with a control group receiving PRN oxycodone from nursing staff. Thirty patients were prospectively randomized into each of 2 groups after total hip arthroplasty. Patient demographics, pain scores, drug dose data, and physical therapy data were collected from chart reviews. Additional data were obtained from patient and nursing surveys. Device patients recorded statistically lower pain scores while taking lower doses of oxycodone on postoperative Day 1 as compared with the control group. Patient surveys indicated that those in the device group reported lower pain scores 24 hours prior to discharge, albeit not statistically different from the control group. Men in the device group reported statistically lower pain scores with physical therapy than men in the control group. Findings from the nursing survey indicate that nurses favored the device over nurse-administered PRN. Patients using the wireless patient-controlled analgesia (PCA) (oral) device had less pain at rest and with activity (men) while taking lower doses of oxycodone with each dose. Nursing surveys indicated that nursing staff in this orthopedic postoperative unit found the device easy to use, reliable, and efficient. They also recommended its adoption for those capable of using it.

PC-FACS

PC-FACS

A Mixed Methods Study of Cross-sectoral Rehabilitation Intervention for Patients with Intermittent Claudication Versus Usual Care for Patients in Non-operative Management. -The Cipic Rehab Study

Introduction: The study examines the effect of a cross-sectoral rehabilitation programme versus usual care for patients conservatively treated for intermittent claudication (IC). Peripheral Artery Disease is one of the most prevalent cardiovascular diseases (1). The most common symptom is IC, defined as a cramping leg pain that occurs during walking and is relieved by a short period of rest. Patients with IC have diminished walking capacity, restricted activity and mobility and reduced health-related quality of life. It leads to social isolation and worsening of the disease with the risk of cardiovascular morbidity and mortality (2). Many patients with IC are not motivated for lifestyle changes (3-5). Non-operative management of IC requires exercise therapy and studies show that supervised exercise training is more effective than unsupervised training (6). The aim of the trial is to investigate the effects of a cross-sectoral exercise and lifestyle intervention based on the established cardiac rehabilitation program versus usual care without rehabilitation in patients with IC. The effects, benefits and motivational factors of conservative management will be examined and patient experiences of the intervention, including factors that support or hinder adherence to the intervention explored. The primary hypothesis is that a specialized rehabilitation program for patients with intermittent claudication improves maximum walking distance at Treadmill Walking Test in the intervention group compared with the control group after the completed intervention. The secondary hypothesis is that pain-free walking distance at Treadmill Walking Test improves in the intervention group compared with the control group after 6 and 12 months. Exploratory analyses will test the hypotheses that IC rehabilitation improves quality of life, diet, smoking, alcohol, physical activity and reduces anxiety and depression after 6 and 12 months. Methods: Based on sample size calculation, 118 patients offered conservative management for IC will be included in the trial. The trial is a cross-sectorial Mixed Method design with 1:1 individual randomization to either the intervention or control group. Patients in the intervention group will receive a pedometer and be asked to self-report walking in a logbook. The intervention consists of a 12-week exercise programme provided by physiotherapists, specialized nurse, clinical dietician and personalized motivational follow-up text messages. A qualitative postintervention study will explore experiences of the intervention consisting surveys with open ended questions, brief interview and focus group interview. Results: Inclusion was initiated in December 2017 and is expected to be completed in May 2019. The inclusion rate is carefully monitored. End of 12-month follow-up of all patients will be in May 2020. Result of the study are expected in October 2020. Conclusion: The Study will provide evidence on rehabilitation needs of patients treated conservatively for IC. Point out recommendations for a specialised IC rehabilitation programme, which healthcare professionals and policymakers may use to make qualified, evidence-based decisions in everyday clinical practice and as a foundation for national and international guidelines. Disclosure: Nothing to disclose

Which Cost Components Influence the Cost of Palliative Care in the Last Hospitalization? A Retrospective Analysis of Palliative Care Versus Usual Care at a Swiss University Hospital

ContextAlthough the number of studies on the economic impact of palliative care (PC) is growing, the great majority report costs from North America. ObjectivesWe aimed to provide a comprehensive overview of PC hospital cost components from the perspective of a European mixed funded health care system by identifying cost drivers of PC and quantifying their effect on hospital costs compared to usual care (UC). MethodsWe performed a retrospective, observational analysis examining cost data from the last hospitalization of patients who died at a large academic hospital in Switzerland comparing patients receiving PC vs. UC. ResultsTotal hospital costs were similar in PC and UC with a mean difference of CHF −2777 [95% CI −12,713 to 8506, P = 0.60]. Average costs per day decreased by CHF −3224 [95% CI −3811 to −2631, P < 0.001] for PC patients with significant reduction of costs for diagnostic intervention and medication. Higher cost components for PC patients were catering, room, nursing, social counseling, and nonmedical therapists. In sensitivity analyses, when we restricted PC exposure to three days from admission, total costs and average costs per day were significantly lower for PC. ConclusionStudies measuring the impact of PC on hospital costs should analyze various cost components beyond total costs to understand wanted and potentially unwanted cost-reducing effects. An international definition of a set of cost components, specific for cost-impact PC studies, may help avoid superficial and potentially dangerous cost discussions.

Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer

Symptom Screening With Targeted Early Palliative Care (STEP) Versus Usual Care for Patients With Advanced Cancer

Physical Therapy Informed by Acceptance and Commitment Therapy (PACT) Versus Usual Care Physical Therapy for Adults With Chronic Low Back Pain: A Randomized Controlled Trial

Chronic low back pain (CLBP) is a major cause of global disability and improving management is essential. Acceptance and commitment therapy (ACT) is a promising treatment for chronic pain but has not been modified for physical therapy. This randomized controlled trial (RCT) compared physical therapy informed by ACT (PACT) against standard care physical therapy for patients with CLBP. Patients with CLBP (duration ≥12 weeks, mean 3 years) were recruited from physical therapy clinics in 4 UK public hospitals. The Roland-Morris Disability Questionnaire (RMDQ) at 3 months’ post-randomization was the primary outcome. Two hundred forty-eight participants (59% female, mean age = 48) were recruited and 219 (88.3%) completed measures at 3 and/or 12 months’ follow-up. At 3 months, PACT participants reported better outcomes for disability (RMDQ mean difference = 1.07, p = .037, 95% CI = −2.08 to −.07, d = .2), Patient Specific Functioning (p = .008), SF12 physical health (p = .032), and treatment credibility (p < .001). At 12 months’ follow-up, there were no significant differences between groups. PACT was acceptable to patients and clinicians and feasible to deliver. Physical therapists incorporated psychological principles successfully and treatment was delivered with high (≥80%) fidelity. Our results may inform the management of CLBP, with potential benefits for patients, health care providers, and society. PerspectivePsychologically informed physical therapy has great potential but there are challenges in implementation. The training and support included in the PACT trial enabled the intervention to be delivered as planned. This successfully reduced disability in the short but not long term. Findings could inform physical therapists’ treatment of CLBP.

Early Protocolized Versus Usual Care Rehabilitation for Pediatric Neurocritical Care Patients: A Randomized Controlled Trial.

s: Few feasibility, safety, and efficacy data exist regarding ICU-based rehabilitative services for children. We hypothesized that early protocolized assessment and therapy would be feasible and safe versus usual care in pediatric neurocritical care patients. Randomized controlled trial. Three tertiary care PICUs in the United States. Fifty-eight children between the ages of 3-17 years with new traumatic or nontraumatic brain insult and expected ICU admission greater than 48 hours. Early protocolized (consultation of physical therapy, occupational therapy, and speech and language therapy within 72 hr ICU admission, n = 26) or usual care (consultation per treating team, n = 32). Primary outcomes were consultation timing, treatment type, and frequency of deferrals and safety events. Secondary outcomes included patient and family functional and quality of life outcomes at 6 months. Comparing early protocolized (n = 26) and usual care groups (n = 32), physical therapy was consulted during the hospital admission in 26 of 26 versus 28 of 32 subjects (p = 0.062) on day 2.4 ± 0.8 versus 7.7 ± 4.8 (p = 0.001); occupational therapy in 26 of 26 versus 23 of 32 (p = 0.003), on day 2.3 ± 0.6 versus 6.9 ± 4.8 (p = 0.001); and speech and language therapy in 26 of 26 versus 17 of 32 (p = 0.011) on day 2.3 ± 0.7 versus 13.0 ± 10.8 (p = 0.026). More children in the early protocolized group had consults and treatments occur in the ICU versus ward for all three services (all p < 0.001). Eleven sessions were discontinued early: nine during physical therapy and two during occupational therapy, none impacting patient outcome. There were no group differences in functional or quality of life outcomes. A protocol for early personalized rehabilitation by physical therapy, occupational therapy, and speech and language therapy in pediatric neurocritical care patients could be safely implemented and led to more ICU-based treatment sessions, accelerating the temporal profile and changing composition of interventions versus usual care, but not altering the total dose of rehabilitation.

High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation

High Flow Nasal Oxygen Versus Usual Care in COPD Pulmonary Rehabiliation

Self-Monitoring by Traffic Light Color Coding Versus Usual Care on Outcomes of Patients With Heart Failure Reduced Ejection Fraction: Protocol for a Randomized Controlled Trial.

BackgroundPatients with heart failure (HF) reduced ejection fraction (HFrEF) have symptoms that are more severe and experience a higher rate of hospitalization compared with HF preserved ejection fraction (HFpEF) patients. However, symptom recognition cannot be made by patients based on current approaches. This problem is a barrier to effective self-care that needs to be improved by new self-monitoring instruments and strategies.ObjectiveThis study describes a protocol for the self-monitoring daily diaries of weight and shortness of breath (SOB) based on the traffic light system (TLS). The primary objective is to compare the self-care between the intervention and control group. Comparison of HF knowledge, HF quality of life (HFQOL), and all-cause hospitalization between the 2 groups are the secondary objectives.MethodsA single-blind randomized controlled trial is being conducted at the HF clinic at Tehran Heart Center (Tehran, Iran). Sixty-eight adult patients of both genders will be enrolled during admission to HF clinic. Eligible subjects will be assigned to either the intervention or control group by a block balanced randomization method. Baseline surveys will be conducted before random allocation. Participants in the intervention group will receive an integrated package consisting of (1) HF self-care education by an Australian Heart Foundation booklet on HF, (2) regular home self-monitoring of weight and SOB, and (3) scheduled call follow-ups for 3 months. Patients in the control group will receive no intervention and they only complete monthly surveys.ResultsThis study is ongoing and is expected to be completed by the end of 2018.ConclusionsThis is the first trial with new self-monitoring instruments in Iran as a low and middle-income country. If the findings show a positive effect, the package will be applied in different regions with the same health care status.Trial RegistrationIranian Registry of Clinical Trials IRCT2017021032476N1; https://en.irct.ir/trial/25296?revision=25296 (Archived by WebCite at http://www.webcitation.org/73DLICQL8)International Registered Report Identifier (IRRID)PRR1-10.2196/9209

Effectiveness and Downstream Healthcare Utilization for Patients That Received Early Physical Therapy Versus Usual Care for Low Back Pain: A Randomized Clinical Trial.

Randomized controlled trial. The aim of this study was to compare early physical therapy versus usual care in patients with low back pain. Early physical therapy (PT) has been associated with reduced downstream healthcare utilization in retrospective studies, but not investigated prospectively in the military health system. Military service members seeking care from a general practitioner were recruited. Patients attended a 20-minute self-management class with focus on psychosocial resilience and then randomized to usual care only (UC) versus immediately starting a 3-week physical therapy program (PT). Primary outcome was the Oswestry Disability Index at 1 year. Secondary outcomes included Oswestry scores at 4- and 12-week follow-up, numeric pain rating scale, global rating of change, and healthcare utilization at 1 year. Analysis of covariance was used to compare differences between groups, significance set at 0.05. clinicaltrials.gov: NCT01556581 RESULTS.: A total of 119 patients (mean age 27.2 years; mean BMI 27.8 kg/m; 15.1% female) enrolled (61 randomized to UC; 58 to PT). No between-group differences found on the Oswestry after 1 year. A between-group difference in Oswestry was present at 4 weeks (mean difference = 4.4; 95% CI: 0.41-10.1; P = 0.042) favoring PT. Total 1-year mean healthcare costs did not differ significantly between groups (UC $5037; 95 CI $4171-$6082 and PT $5299; 95 CI $4367-$6431). The portion of total mean healthcare costs related to low back pain was lower for UC ($1096; 95% CI $855-$1405) compared to PT ($2016, 95% CI $1570-$2590). There was no difference between usual care and early PT after 1 year. PT provided greater improvement in disability after 4 weeks. As both groups improved, the impact of the education may have been underestimated. Patients in the PT group utilized greater back-pain-related healthcare resources, but overall healthcare costs did not differ compared to UC. 2.

Healthy Lungs Study: A Randomised Controlled Trial of a Community Intervention Programme Versus Usual Care to Prevent Chronic Respiratory Symptoms in Children Following Severe Bronchiolitis or Pneumonia

Background: Bronchiectasis prevalence has increased, especially in indigenous children. One evolutionary pathway follows hospitalisation with severe lower respiratory tract infection (LRTI) in early childhood. We aimed to reduce the intermediate respiratory morbidity with an intervention programme introduced at discharge. Methods: This randomised, controlled, single-blind trial enrolled children aged <2 years hospitalised for severe LRTI to intervention or control. Intervention was minimum three monthly community assessments treating wet cough with prolonged antibiotics and referral for investigation of non-responders. All other health issues were addressed, health resilience behaviours encouraged, with referrals for environmental concerns (housing, smoking). Controls followed the usual pathway of caregiver-initiated healthcare access. After 24 months all children were assessed by a paediatrician blinded to randomisation for primary outcomes of wet cough, abnormal examination (crackles or clubbing) or chest x-ray Brasfield score ≤22 when in stable health. This study is registered ACTRN12610001095055. Findings: March 2011-September 2012, we enrolled 400 children (203 intervention, 197 control); mean age 6•9 months, 230 boys, 87% Maori/Pasifika ethnicity, and 83% from the most deprived quintile. Final assessment of 321/400 (80•3%) showed no differences in presence of wet cough (33•9% intervention, 36•5% controls, p=0•63), abnormal examination (21•7% intervention, 23•9% controls, p=0•75) or Brasfield score ≤22 (32•4% intervention, 37•9% control, p=0•3). Twelve (all intervention) developed bronchiectasis. Interpretation: We have identified children at high risk of developing chronic suppurative lung disease. This intervention programme did not improve outcomes but future preventative strategies should target this population. Trial Registration Number: This study is registered at Australian and New Zealand Clinical Trials RegistryACTRN12610001095055. Funding: Health Research Council of New Zealand (10/510), Asthma and Respiratory Foundation, Lottery Health Research, and Maurice and Phyllis Paykel Trust. Declaration of Interest: We declare that we have no conflicts of interests. Ethical Approval: The study was approved by the Human Disability Ethics Committee NTX/10/09/094. Caregivers provided written, informed consent prior to enrolment.

Web-Based Versus Usual Care and Other Formats of Decision Aids to Support Prostate Cancer Screening Decisions: Systematic Review and Meta-Analysis.

BackgroundProstate cancer is a leading cause of cancer among men. Because screening for prostate cancer is a controversial issue, many experts in the field have defended the use of shared decision making using validated decision aids, which can be presented in different formats (eg, written, multimedia, Web). Recent studies have concluded that decision aids improve knowledge and reduce decisional conflict.ObjectiveThis meta-analysis aimed to investigate the impact of using Web-based decision aids to support men’s prostate cancer screening decisions in comparison with usual care and other formats of decision aids.MethodsWe searched PubMed, CINAHL, PsycINFO, and Cochrane CENTRAL databases up to November 2016. This search identified randomized controlled trials, which assessed Web-based decision aids for men making a prostate cancer screening decision and reported quality of decision-making outcomes. Two reviewers independently screened citations for inclusion criteria, extracted data, and assessed risk of bias. Using a random-effects model, meta-analyses were conducted pooling results using mean differences (MD), standardized mean differences (SMD), and relative risks (RR).ResultsOf 2406 unique citations, 7 randomized controlled trials met the inclusion criteria. For risk of bias, selective outcome reporting and participant/personnel blinding were mostly rated as unclear due to inadequate reporting. Based on seven items, two studies had high risk of bias for one item. Compared to usual care, Web-based decision aids increased knowledge (SMD 0.46; 95% CI 0.18-0.75), reduced decisional conflict (MD –7.07%; 95% CI –9.44 to –4.71), and reduced the practitioner control role in the decision-making process (RR 0.50; 95% CI 0.31-0.81). Web-based decision aids compared to printed decision aids yielded no differences in knowledge, decisional conflict, and participation in decision or screening behaviors. Compared to video decision aids, Web-based decision aids showed lower average knowledge scores (SMD –0.50; 95% CI –0.88 to –0.12) and a slight decrease in prostate-specific antigen screening (RR 1.12; 95% CI 1.01-1.25).ConclusionsAccording to this analysis, Web-based decision aids performed similarly to alternative formats (ie, printed, video) for the assessed decision-quality outcomes. The low cost, readiness, availability, and anonymity of the Web can be an advantage for increasing access to decision aids that support prostate cancer screening decisions among men.