Blinded Outcome Assessment Research Articles

Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease.

Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease.

PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke\u2014statistical analysis plan of a randomised, open, phase III, clinical trial with blinded outcome assessment

RationaleAspiration, infections, and fever are common in the first days after stroke, especially in older patients. The occurrence of these complications has been associated with an increased risk of death or dependency.Aims and designPREvention of Complications to Improve OUtcome in elderly patients with acute Stroke (PRECIOUS) is an international, multi-centre, 3 × 2 factorial, randomised, controlled, open-label clinical trial with blinded outcome assessment, which will assess whether prevention of aspiration, infections, or fever with metoclopramide, ceftriaxone, paracetamol, respectively, or any combination of these in the first 4 days after stroke onset improves functional outcome at 90 days in elderly patients with acute stroke.DiscussionThis statistical analysis plan provides a technical description of the statistical methodology and unpopulated tables and figures. The paper is written prior to data lock and unblinding of treatment allocation.Trial registrationISRCTN registry ISRCTN82217627. Registered on 22 September 2015. The trial was prospectively registered.

NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial

BackgroundSecondary damage due to neurochemical and inflammatory changes in the penumbra in the first days after ischemic stroke contributes substantially to poor clinical outcome. In animal models, vagus nerve stimulation (VNS) inhibits these detrimental changes and thereby reduces tissue injury. The aim of this study is to investigate whether non-invasive cervical VNS (nVNS) in addition to the current standard treatment can improve penumbral recovery and limit final infarct volume.MethodsNOVIS is a single-center prospective randomized clinical trial with blinded outcome assessment. One hundred fifty patients will be randomly allocated (1:1) within 12 h from clinical stroke onset to nVNS for 5 days in addition to standard treatment versus standard treatment alone. The primary endpoint is the final infarct volume on day 5 assessed with MRI.DiscussionWe hypothesize that nVNS will result in smaller final infarct volumes as compared to standard treatment due to improved penumbral recovery. The results of this study will be used to assess the viability and approach to power a larger trial to more definitively assess the clinical efficacy of nVNS after stroke.Trial registrationClinicalTrials.govNCT04050501. Registered on 8 August 2019

Cluster-randomized controlled trial for the early promotion of clinic visits for untreated hypertension.

Despite clear evidence of the benefits of lowering blood pressure among patients with hypertension, the treatment rate remains <40% worldwide. In the present trial, we aimed to investigate the effects of the early promotion of clinic visits among patients with untreated hypertension detected during annual health checkups. This was a worksite-based, parallel group, cluster-randomized trial with blinded outcome assessment. Employees of 152 Japanese supermarket stores found to have untreated hypertension (blood pressure levels ≥ 160/100 mmHg) during health checkups were assigned to an early promotion group (encouraged to visit a clinic in face-to-face interviews and provided with a referral letter to a physician as well as a leaflet) or a control group (received usual care), according to random assignment. The primary outcome was the completion of a clinic visit within 6 months. Odds ratios with 95% confidence intervals for the early promotion group versus the control group were estimated using multilevel logistic regression with random effects of clusters. A total of 273 participants (mean age 50.3 years, 55% women) from 107 stores were assigned to the early promotion group (138 from 55 stores) or control group (135 from 52 stores). During the 6-month follow-up, 47 (34.1%) participants in the early promotion group visited a clinic, as did 26 (19.3%) in the control group (odds ratio 2.33, 95% confidence interval 1.12-4.84, P = 0.024). Early promotion using a referral letter during health checkups significantly increased the number of clinic visits within 6 months completed by participants with untreated hypertension (UMIN000025411).

Blinding in randomised clinical trials of psychological interventions: a retrospective study of published trial reports

ObjectivesTo study the extent of blinding in randomised clinical trials of psychological interventions and the interpretative considerations if randomised clinical trials are not blinded.DesignRetrospective study of trial reports published in...

A randomized controlled trial of laser-assisted ICSI

Does the use of a laser to open the zona pellucida during ICSI (laser assisted or LA-ICSI) improve oocyte survival, embryo development and clinical outcomes? Compared to conventional ICSI, LA-ICSI increased rates of oocyte survival and some aspects of embryo development but it did not alter the ongoing pregnancy rate; after adjusting for oocyte survival, there was no beneficial effect of LA-ICSI on embryo development and utilization. Oocyte degeneration occurs in a 10th of mature oocytes after ICSI. Pilot studies suggest that LA-ICSI may improve oocyte survivability. In a randomized controlled trial, 966 couples (16122 metaphase II oocytes) were allocated to receive LA-ICSI (intervention) or conventional ICSI (control) between 17 September 2018 and 5 August 2019. Oocyte survival (primary endpoint), embryo development and ongoing pregnancy rates were compared. Couples included in this study were recommended for ICSI due to female or male factor, unexplained infertility or a combination of factors. Patients were ineligible to participate in the study if they had uterine abnormality including thin endometrium, recurrent pregnancy loss, endometriosis or a severe medical condition. Concealed randomization to LA-ICSI or conventional ICSI, allocated in a 1:1 ratio, took place on stimulation Day 1 with replacement of blastocysts on only Day 5. The primary endpoint was oocyte survival with membrane integrity 24 h after the ICSI procedure. The sample size was estimated to detect a 3% increase in oocyte survival after LA-ICSI with 99% power at a 1% significance level. This also permitted the detection of 10% increase in ongoing pregnancy rate after LA-ICSI with 85% power at 5% alpha level. We used Poisson regression with zero-inflation for count data to estimate relative risk (RR) with 95% CI and logistic regression for clinical outcomes to estimate odds ratio (OR) with 95% CI. Both models adjusted for age as a covariate. Compared with conventional ICSI, LA-ICSI resulted in a higher number of surviving oocytes (RR 1.08, 95% CI 1.05-1.12, P < 0.001), as well as a higher number of fertilized oocytes (RR 1.08, 95% CI 1.04-1.13, P < 0.001) and utilizable blastocysts (RR 1.09, 95% CI 1.04-1.15, P < 0.001). Sensitivity analyses adjusted for oocyte survival showed no between-group difference in utilizable blastocysts (OR 1.01, 95% CI 0.95-1.08, P = 0.73) and by calculating the mean rate, a reduction in utilizable blastocysts was shown (RR 0.95, 95% CI 0.94-0.97, P < 0.001). Ongoing pregnancy showed no between-group difference (LA-ICSI 179/489 (37%) vs ICSI 201/477 (42%), OR 0.79, 95% CI 0.61-1.03, P = 0.09). It was not possible to blind the embryologists involved in the ICSI procedure. However, there was concealment of randomization and blinding of outcome assessments reducing the risk of selection and measurement bias. A beneficial effect of LA-ICSI on oocyte survival should be shown to improve clinical outcomes, before its use in clinical practice is justified. The study received no funding, and the authors declare that there are no conflicts of interest. NCT03665103. 11 September 2018. 17 September 2018.

Adequacy of risk of bias assessment in surgical vs non-surgical trials in Cochrane reviews: a methodological study

BackgroundBias in randomized controlled trials (RCTs) can lead to underestimation or overestimation of the true effects of interventions. Surgical RCTs may suffer from the risk of bias (RoB) that is avoidable in trials of other interventions, and vice versa. We aimed to compare the adequacy of RoB assessments in surgical versus non-surgical RCTs included in Cochrane reviews and to assess the most common differences in those RoB assessments. Due to specificities of surgical trials, i.e. difficulties associated with blinding of surgical interventions, we hypothesized that assessments of surgical trials may be more adequate, compared to RCTs of non-surgical interventions.MethodsThis was a methodological study, analyzing methods of published Cochrane systematic reviews. Data were extracted from RoB tables in Cochrane reviews (judgments and accompanying explanatory comment) for the following four RoB domains used in the 2011 Cochrane RoB tool: randomization, allocation concealment, blinding of participants and personnel, and blinding of outcome assessors. We defined adequate assessments as those that were in line with instructions from the Cochrane Handbook for Systematic Reviews of Interventions. The prevalence of adequate assessments was compared in surgical versus non-surgical trials. The most common differences in both groups of reviews were presented.ResultsIn 729 analyzed Cochrane reviews, there were 10,537 included trials. The prevalence of adequate RoB judgments made by Cochrane authors ranged from 87.9, 95%CI (87.3 to 88.6%) for randomization to 70.7, 95%CI (69.8 to 71.5%) for blinding of participants and personnel. For all analyzed RoB domains, the prevalence of adequate RoB domains was higher in surgical trials than in non-surgical trials. For two RoB domains assessing blinding, this difference between surgical and non-surgical trials was statistically significant (P < 0.001), while the difference was not significant for the RoB domain regarding randomization (P = 0.124) and allocation concealment (P = 0.039, β < 0.8).ConclusionsRoB judgments were more in line with instructions from the Cochrane Handbook when Cochrane reviews assessed surgical trials, compared to those that analyzed non-surgical interventions. However, further steps are warranted to scrutinize RoB assessment in trials of both surgical and non-surgical interventions.

How Satisfied Are Patients and Surgeons with Telemedicine in Orthopaedic Care During the COVID-19 Pandemic? A Systematic Review and Meta-analysis.

The coronavirus disease 2019 pandemic has resulted in a rapid pivot toward telemedicine owing to closure of in-person elective clinics and sustained efforts at physical distancing worldwide. Throughout this period, there has been revived enthusiasm for delivering and receiving orthopaedic care remotely. Unfortunately, rapidly published editorials and commentaries during the pandemic have not adequately conveyed findings of published randomized trials on this topic. In this systematic review and meta-analysis of randomized trials, we asked: (1) What are the levels of patient and surgeon satisfaction with the use of telemedicine as a tool for orthopaedic care delivery? (2) Are there differences in patient-reported outcomes between telemedicine visits and in-person visits? (3) What is the difference in time commitment between telemedicine and in-person visits? In accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a systematic review with the primary objective to determine patient and surgeon satisfaction with telemedicine, and secondary objectives to determine differences in patient-reported outcomes and time commitment. We used combinations of search keywords and medical subject headings around the terms "telemedicine", "telehealth", and "virtual care" combined with "orthopaedic", "orthopaedic surgery" and "randomized." We searched three medical databases (MEDLINE, Embase, and the Cochrane Library) in duplicate and performed manual searches to identify randomized controlled trials evaluating the outcomes of telemedicine and in-person orthopaedic assessments. Trials that studied an intervention that was considered to be telemedicine (that is, any form of remote or virtual care including, but not limited to, video, telephone, or internet-based care), had a control group that comprised in-person assessments performed by orthopaedic surgeons, and were reports of Level I original evidence were included in this study. Studies evaluating physiotherapy or rehabilitation interventions were excluded. Data was extracted by two reviewers and quantitative and qualitive summaries of results were generated. Methodological quality of included trials was assessed using the Cochrane Risk of Bias tool, which uniformly rated the trials at high risk of bias within the blinding categories (blinding of providers, patients, and outcome assessors). We screened 133 published articles; 12 articles (representing eight randomized controlled trials) met the inclusion criteria. There were 1008 patients randomized (511 to telemedicine groups and 497 to control groups). Subspecialties represented were hip and knee arthroplasty (two trials), upper extremity (two trials), pediatric trauma (one trial), adult trauma (one trial), and general orthopaedics (two trials). There was no difference in the odds of satisfaction between patients receiving telemedicine care and those receiving in-person care (pooled odds ratio 0.89 [95% CI 0.40 to 1.99]; p = 0.79). There were also no differences in surgeon satisfaction (pooled OR 0.38 [95% CI 0.07 to 2.19]; p = 0.28) or among multiple patient-reported outcome measures that evaluated pain and function. Patients reported time savings, both when travel time was excluded (17 minutes shorter [95% CI 2 to 32]; p = 0.03) and when it was included (180 minutes shorter [95% CI 78 to 281]; p < 0.001). Evidence from heterogeneous randomized studies demonstrates that the use of telemedicine for orthopaedic assessments does not result in identifiable differences in patient or surgeon satisfaction compared with in-person assessments. Importantly, the source studies in this review did not adequately capture or report safety endpoints, such as complications or missed diagnoses. Future studies must be adequately powered to detect these differences to ensure patient safety is not compromised with the use of telemedicine. Although telemedicine may lead to a similar patient experience, surgeons should maintain a low threshold for follow-up with in-person assessments whenever possible in the absence of further safety data. Level I, therapeutic study.

Conservative Treatment for Acute Ankle Sprain: A Systematic Review.

The aim was to identify conservative treatments available for acute ankle sprain and to evaluate their effectiveness with respect to pain relief and short-term recovery of functional capacity. A systematic review of the relevant literature was conducted via a data search of the PROSPERO, PubMed, Scopus, CINAHL, PyscINFO and SPORTDiscus databases, from inception until December 2019, focusing on randomised control trial studies. Two of the authors independently assessed the quality of each study located and extracted the relevant data. The quality of each paper was assessed using the Cochrane risk of bias tool included in RevMan 5. In all, 20 studies met the inclusion criteria. In terms of absence of bias, only nine papers were classed as “high quality”. Studies (75%) were of low quality in terms of the blinding of participants and personnel and uncertainty in blinding of outcome assessment and all presented one or more other forms of bias. Despite the generally low quality of the studies considered, it can be concluded that conservative treatment for acute ankle sprain normally achieves pain relief and rapidly improved functionality. Research based on higher-quality study designs and procedures would enable more definitive conclusions to be drawn.

Agreement of Risk-of -Bias varied in systematic reviews on acupuncture and was associated with methodological quality

ObjectivesThe objective of the study was to evaluate the consistency of risk of bias assessments for overlapping randomized controlled trials (RCTs) included in systematic reviews (SRs) on acupuncture. Study Design and SettingDatabases were searched for acupuncture SRs. A weighted kappa (κ) statistic was calculated, and logistic regression was used to explore the factors of disagreements. ResultsWe included 241 RCTs from 109 SRs on acupuncture. The percentage disagreements ranged from 25% to 44%, with moderate agreement for random sequence generation (κ = 0.57), allocation concealment (κ = 0.50), and incomplete outcome data (κ = 0.50), besides fair agreement for blinding of participants and personnel (κ = 0.44), blinding of outcome assessment (κ = 0.31), and selective reporting (κ = 0.39). Only 19% RCTs were evaluated completely consistent. Methodological quality (random sequence generation, odds ratio (OR) = 3.46), international cooperation (allocation concealment, OR = 0.14; incomplete outcome data, OR = 0.14; selective reporting, OR = 0.05), and risk of bias reporting completeness score (selective reporting, OR = 0.53) significantly affected the relative odds of disagreements. ConclusionThe level of agreement varied from fair to moderate agreement depending on the risk of bias domain. Methodological quality appears to be an overarching factor to account for disagreements.

Staged angioplasty versus regular carotid artery stenting in patients with carotid artery stenosis at high risk of hyperperfusion: a randomised clinical trial

Background and purposeHyperperfusion (HP) is a devastating complication associated with carotid artery stenting (CAS) or endarterectomy. The efficacy and safety of staged angioplasty (SAP) in patients with CAS at high...

Critically appraised paper: Tailored prescription of digitally enabled rehabilitation may improve mobility, but not physical activity, in geriatric and neurological rehabilitation [commentary

Question: Does tailored prescription of digitally enabled rehabilitation using affordable devices improve mobility and physical activity in people with mobility limitations admitted to aged care or neurological rehabilitation? Design: Pragmatic, parallel-group, randomised controlled trial with concealed allocation and blinded outcome assessment. Setting: Three inpatient rehabilitation (aged care, neurological rehabilitation) hospitals in Australia. Participants: Adults with reduced mobility (defined using Short Physical Performance Battery score 12 months, anticipated length of stay at least 10 days from randomisation, and able to maintain standing position (assistance of one person permitted). Key exclusion criteria were cognitive or visual impairment likely to interfere with device use, inability to communicate in English, medical conditions prohibiting exercise and anticipated discharge to nursing home. Randomisation of 300 participants allocated 149 to usual care plus digitally enabled rehabilitation and 151 to usual care only. Interventions: Both groups received usual multidisciplinary rehabilitation care. In addition, the intervention group was prescribed 30 to 60 minutes of digitally enabled rehabilitation (virtual reality video games, activity monitors, tablet and smartphone exercise applications) 5 days a week in hospital and after discharge (using loaned devices) for 6 months. The digitally enabled rehabilitation was individually tailored and progressed by a physiotherapist. Outcome measures: Co-primary outcomes were mobility (performance-based Short Physical Performance Battery) and upright time as a proxy for physical activity (proportion of day upright measured by activPAL, averaged over 7 days) 6 months after randomisation. Secondary outcomes included performance- based and patient-reported measures of mobility and physical activity. Results: A total of 258 participants (129 control,129 intervention) completed the 6-month assessments. At the 6-month follow-up, the change in mobility score on the Short Physical Performance Battery was greater for the intervention group than the control group (MD0.2 points, 95% CI 0.1 to 0.3), but there was no evidence of a between-group difference in upright time (MD -0.2, 95% CI -2.7 to 2.3). Between-group differences favoured the intervention group across most secondary mobility outcomes, but there was no evidence of between-group differences for most other secondary outcomes including steps taken per day. Conclusion: Digitally enabled rehabilitation to promote mobility and physical activity in mobility-limited adults receiving geriatric or neurological inpatient rehabilitation can improve mobility, but does not appear to increase time spent upright.

A mixed methods randomised feasibility trial investigating the management of benign paroxysmal positional vertigo in acute traumatic brain injury

BackgroundTraumatic brain injury (TBI) is the leading cause of long-term disability in working age adults. Recent studies show that most acute TBI patients demonstrate vestibular features of dizziness and imbalance, often from combined peripheral and central vestibular dysfunction. Effective treatment for vestibular impairments post-TBI is important given its significant adverse impact upon quality of life and employment prospects. The most frequent peripheral vestibular disorder in acute TBI is benign paroxysmal positional vertigo (BPPV), affecting approximately half of acute cases. Although there is effective treatment for idiopathic BPPV, there are no high-quality clinical data for post-TBI BPPV regarding its prevalence, natural history, which treatment is most effective and when is the best time to treat. In particular, observational studies suggest post-TBI BPPV may be recurrent, indicating that hyperacute treatment of BPPV may be futile. Given the potential hurdles and the lack of accurate post-TBI BPPV data, the current study was designed to provide information regarding the feasibility and optimal design of future large-scale prospective treatment studies that would compare different interventions and their timing for post-TBI BPPV.MethodA multi-centre randomised mixed methods feasibility study design was employed. We aim to recruit approximately 75 acute TBI patients across a range of clinical severities, from three major trauma centres in London. Patients will be randomised to one of three treatment arms: (1) therapist-led manoeuvres, (2) patient-led exercises and (3) advice. Participants will be re-assessed by blinded outcome assessors at 4 and 12 weeks. Acceptability of the intervention will be obtained by patient interviews at the end of their treatment and therapist interviews at the end of the study. Primary outcomes relate to feasibility parameters including recruitment and retention rates, adverse events and intervention fidelity. We will also aim to provide a more accurate estimate of the prevalence of BPPV in TBI cases on the trauma ward.DiscussionThe multi-centre nature of our feasibility study will inform the design of a future prospective treatment trial of BPPV in acute TBI. Important parameters we will obtain from this study, key for designing a future prospective treatment study, include estimating the prevalence of BPPV in TBI patients admitted to UK major trauma wards, and elucidating both patient and care-provider barriers in delivering BPPV treatment.Trial registrationISRCTN, ISRCTN91943864. Registered on 10 February 2020.

Yoga programme for type-2 diabetes prevention (YOGA-DP) among high risk people in India: a multicentre feasibility randomised controlled trial protocol

IntroductionA huge population in India is at high risk of type-2 diabetes (T2DM). Physical activity and a healthy diet (healthy lifestyle) improve blood glucose levels in people at high risk...

Corticosteroid therapy for nephrotic syndrome in children.

Corticosteroid therapy for nephrotic syndrome in children.

Improving Patients' Medication Adherence and Outcomes in Nonhospital Settings Through eHealth: Systematic Review of Randomized Controlled Trials.

BackgroundElectronic health (eHealth) refers to the use of information and communication technologies for health. It plays an increasingly important role in patients’ medication management.ObjectiveTo assess evidence on (1) whether eHealth for patients’ medication management can improve drug adherence and health outcomes in nonhospital settings and (2) which eHealth functions are commonly used and are effective in improving drug adherence.MethodsWe searched for randomized controlled trials (RCTs) on PubMed, MEDLINE, CINAHL, EMBASE, EmCare, ProQuest, Scopus, Web of Science, ScienceDirect, and IEEE Xplore, in addition to other published sources between 2000 and 2018. We evaluated the studies against the primary outcome measure of medication adherence and multiple secondary health care outcome measures relating to adverse events, quality of life, patient satisfaction, and health expenditure. The quality of the studies included was assessed using the Cochrane Collaboration’s Risk of Bias (RoB) tool.ResultsOur initial search yielded 9909 records, and 24 studies met the selection criteria. Of these, 13 indicated improvement in medication adherence at the significance level of P<.1 and 2 indicated an improved quality of life at the significance level of P<.01. The top 3 functions that were employed included mechanisms to communicate with caregivers, monitoring health features, and reminders and alerts. eHealth functions of providing information and education, and dispensing treatment and administration support tended to favor improved medication adherence outcomes (Fisher exact test, P=.02). There were differences in the characteristics of the study population, intervention design, functionality provided, reporting adherence, and outcome measures among the included studies. RoB assessment items, including blinding of outcome assessment and method for allocation concealment, were not explicitly reported in a large number of studies.ConclusionsAll the studies included were designed for patient home-based care application and provided a mechanism to communicate with caregivers. A targeted study population such as older patients should be considered to maximize the public health impact on the self-management of diseases.Trial RegistrationInternational Prospective Register of Systematic Reviews (PROSPERO) CRD42018096627; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=96627

Survivors of Intensive Care With Type 2 Diabetes and the Effect of Shared-Care Follow-Up Clinics: The SWEET-AS Randomized Controlled Pilot Study

Follow-up clinics after ICU admission have demonstrated limited benefit. However, existing trials have evaluated heterogeneous cohorts and used physicians who had limited training in outpatient care. What are the effects of a "shared-care" intensivist-endocrinologist clinic for ICU survivors with type 2 diabetes on process measures and clinical outcomes 6months after hospital discharge, and is it feasible to conduct a larger trial? This was a prospective, randomized, single-center pilot study with blinded outcome assessment. Patients with type 2 diabetes, who required≥ 5days of ICU care (mixed medical-surgical ICU) and survived to ICU discharge, were eligible. Participants were randomized to attendance at the shared-care clinic 1month after hospital discharge or usual care. Six months after hospital discharge, participants were assessed for outcomes including glycated hemoglobin, neuropathy, nephropathy, quality of life, return to employment, frailty, and health-care use. The primary outcome was participant recruitment and retention. During an 18-month period, 42 of 82 eligible patients (51%) were recruited. Four participants (10%) withdrew before assessment at 6months and 11 (26%) died. At 6months, only 18 of 38 participants who did not withdraw (47%) were living independently without support, and 24 (63%) required at least one subsequent hospital admission. In the intervention group (n= 21), 16 (76%) attended the clinic. Point estimates did not indicate that the intervention improved glycated hemoglobin (+5.6mmol/mol; 95%CI, -6.3 to 17; P= .36) or quality of life (36-Item Short Form Survey physical summary score, 32 [9] vs. 32 [7]; P= 1.0). Outcomes for ICU survivors with type 2 diabetes are poor. Because of low participation and high mortality, a larger trial of a shared-care follow-up clinic in this cohort, using the present design, does not appear feasible. Australian New Zealand Clinical Trials Registry (ANZCTR); No.: ACTRN12616000206426; URL: www.anzctr.org.au.

Interventions to facilitate shared decision-making using decision aids with patients in Primary Health Care: A systematic review.

Background:Shared decision making (SDM) is a process within the physician–patient relationship applicable to any clinical action, whether diagnostic, therapeutic, or preventive in nature. It has been defined as a process of mutual respect and participation between the doctor and the patient. The aim of this study is to determine the effectiveness of decision aids (DA) in primary care based on changes in adherence to treatments, knowledge, and awareness of the disease, conflict with decisions, and patients’ and health professionals’ satisfaction with the intervention.Methods:A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was conducted in Medline, CINAHL, Embase, the Cochrane Central Register of Controlled Trials, and the NHS Economic Evaluation Database. The inclusion criteria were randomized clinical trials as study design; use of SDM with DA as an intervention; primary care as clinical context; written in English, Spanish, and Portuguese; and published between January 2007 and January 2019. The risk of bias of the included studies in this review was assessed according to the Cochrane Collaboration's tool.Results:Twenty four studies were selected out of the 201 references initially identified. With the use of DA, the use of antibiotics was reduced in cases of acute respiratory infection and decisional conflict was decreased when dealing with the treatment choice for atrial fibrillation and osteoporosis. The rate of determination of prostate-specific antigen (PSA) in the prostate cancer screening decreased and colorectal cancer screening increased. Both professionals and patients increased their knowledge about depression, type 2 diabetes, and the perception of risk of acute myocardial infarction at 10 years without statins and with statins. The satisfaction was greater with the use of DA in choosing the treatment for depression, in cardiovascular risk management, in the treatment of low back pain, and in the use of statin therapy in diabetes. Blinding of outcomes assessment was the most common bias.Conclusions:DA used in primary care are effective to reduce decisional conflict and improve knowledge on the disease and treatment options, awareness of risk, and satisfaction with the decisions made. More studies are needed to assess the impact of shared decision making in primary care.

Prevention of benign paroxysmal positional vertigo with vitamin D supplementation

To assess the effect of vitamin D and calcium supplementation in preventing recurrences of benign paroxysmal positional vertigo (BPPV). We performed an investigator-initiated, blinded-outcome assessor, parallel, multicenter, randomized controlled trial in 8 hospitals between December 2013 and May 2017. Patients with confirmed BPPV were randomly assigned to the intervention (n = 518) or the observation (n = 532) group after successful treatment with canalith repositioning maneuvers. The primary outcome was the annual recurrence rate (ARR). Patients in the intervention group had taken vitamin D 400 IU and 500 mg of calcium carbonate twice a day for 1 year when serum vitamin D level was lower than 20 ng/mL. Patients in the observation group were assigned to follow-ups without further vitamin D evaluation or supplementation. The intervention group showed a reduction in the ARR (0.83 [95% confidence interval (CI), 0.74-0.92] vs 1.10 [95% CI, 1.00-1.19] recurrences per 1 person-year) with an incidence rate ratio of 0.76 (95% CI, 0.66-0.87, p < 0.001) and an absolute rate ratio of -0.27 (-0.40 to -0.14) from intention-to-treat analysis. The number needed to treat was 3.70 (95% CI, 2.50-7.14). The proportion of patients with recurrence was also lower in the intervention than in the observation group (37.8 vs 46.7%, p = 0.005). Supplementation of vitamin D and calcium may be considered in patients with frequent attacks of BPPV, especially when serum vitamin D is subnormal. This study provides Class III evidence that for patients with BPPV, vitamin D and calcium supplementation reduces recurrences of BPPV.

Vigabatrin add-on therapy for drug-resistant focal epilepsy.

This is an updated version of the original Cochrane Review published in 2008 and updated in 2013. Epilepsy is a common neurological condition which affects up to 1% of the population. Approximately 30% of people with epilepsy do not respond to treatment with currently available drugs. The majority of these people have focal epilepsy. Vigabatrin is an antiepileptic drug licensed for use in drug-resistant epilepsy. To assess the efficacy and tolerability of vigabatrin as an add-on therapy for people with drug-resistant focal epilepsy. For the latest update of this review, we searched the following databases on 1 November 2018: Cochrane Register of Studies (CRS Web), MEDLINE (Ovid 1946 to 31 October 2018), ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform. The Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL) are both included in the Cochrane Register of Studies (CRS Web). We checked reference lists of retrieved studies for additional reports of relevant studies and contacted Hoechst Marion Roussel (manufacturers of vigabatrin) in 2000. We included randomised, double-blind, placebo-controlled, fully published trials of vigabatrin in people of any age with drug-resistant focal epilepsy. Two review authors assessed trials for inclusion and extracted data using the standard methodological procedures expected by Cochrane. Primary analysis was by intention-to-treat (ITT). We evaluated: 50% or greater reduction in seizure frequency, treatment withdrawal, adverse effects, dose-response analysis, cognitive outcomes and quality of life. We presented results as risk ratios (RR) with 95% or 99% confidence intervals (CI). We identified 11 trials that included 756 participants (age range: 10 to 64 years). The trials tested vigabatrin doses between 1 g/day and 6 g/day. All 11 trials displayed a risk of bias across at least three risk of bias domains. Predominantly, the risk of bias was associated with: allocation concealment (selection bias), blinding of outcome assessment (detection bias) and incomplete outcome data (attrition bias). Participants treated with vigabatrin may be two to three times more likely to obtain a 50% or greater reduction in seizure frequency compared with those treated with placebo (RR 2.60, 95% CI 1.87 to 3.63; 4 studies; low-certainty evidence). Those treated with vigabatrin may also be three times more likely to have treatment withdrawn although we are uncertain (RR 2.86, 95% CI 1.25 to 6.55; 4 studies; very low-certainty evidence). Compared to placebo, participants given vigabatrin were more likely to experience adverse effects: dizziness/light-headedness (RR 1.74, 95% CI 1.05 to 2.87; 9 studies; low-certainty evidence), fatigue (RR 1.65, 95% CI 1.08 to 2.51; 9 studies; low-certainty evidence), drowsiness (RR 1.70, 95% CI 1.18 to 2.44; 8 studies) and depression (RR 3.28, 95% CI 1.30 to 8.27; 6 studies). Although the incidence rates were higher among participants receiving vigabatrin compared to those receiving placebo, the effect was not significant for the following adverse effects: ataxia (RR 2.76, 95% CI 0.96 to 7.94; 7 studies; very low-certainty evidence), nausea (RR 3.57, 95% CI 0.63 to 20.30; 4 studies), abnormal vision (RR 1.64, 95% CI 0.67 to 4.02; 5 studies; very low-certainty evidence), headache (RR 1.23, 95% CI 0.79 to 1.92; 9 studies), diplopia (RR 1.76, 99% CI 0.94 to 3.30) and nystagmus (RR 1.53, 99% CI 0.62 to 3.76; 2 studies; low-certainty evidence). Vigabatrin had little to no effect on cognitive outcomes or quality of life. Vigabatrin may significantly reduce seizure frequency in people with drug-resistant focal epilepsy. The results largely apply to adults and should not be extrapolated to children under 10 years old. Short-term follow-up of participants showed that some adverse effects were associated with its use. Analysis of longer-term observational studies elsewhere, however, has demonstrated that vigabatrin use can lead to the development of visual field defects.