Use of wearable biometric monitoring devices to measure outcomes in randomized clinical trials: a methodological systematic review.

BACKGROUND: Wearable biometric monitoring devices (BMDs) have the potential to transform the conduct of randomized controlled trials (RCTs) by shifting the collection of outcome data from single measurements at predefined time points to dense continuous measurements. METHODS: Methodological systematic review to understand how recent RCTs used BMDs to measure outcomes and to describe the reporting of these RCTs. Electronic search was performed in the Cochrane Central Register of Controlled Trials, PubMed, and EMBASE and completed a page-by-page hand search in five leading medical journals between January 1, 2018, and December 31, 2018. Three reviewers independently extracted all primary and secondary outcomes collected using BMDs, and assessed (1) the definitions used to summarize BMD outcome data; (2) whether the validity, reliability, and responsiveness of sensors was reported; (3) the discrepancy with outcomes prespecified in public clinical trial registries; and (4) the methods used to manage missing and incomplete BMD outcome data. RESULTS: Of the 4562 records screened, 75 RCTs were eligible. Among them, 24% tested a pharmacological intervention and 57% used an inertial measurement sensor to measure physical activity. Included trials involved 464 outcomes (average of 6 [SD = 8] outcomes per trial). In total, 35 trials used a BMD to measure a primary outcome. Several issues affected the value and transparency of trials using BMDs to measure outcomes. First, the definition of outcomes used in the trials was highly heterogeneous (e.g., 21 diabetes trials had 266 outcomes and 153 had different unique definitions to measure diabetes control), which limited the combination and comparison of results. Second, information on the validity, reliability, and responsiveness of sensors used was lacking in 74% of trials. Third, half (53%) of the outcomes measured with BMDs had not been prespecified, with a high risk of outcome reporting bias. Finally, reporting on the management of incomplete outcome data (e.g., due to suboptimal compliance with the BMD) was absent in 68% of RCTs. CONCLUSIONS: Use of BMDs to measure outcomes is becoming the norm rather than the exception in many fields. Yet, trialists need to account for several methodological issues when specifying and conducting RCTs using these novel tools.

Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: rationale and implementation.

BACKGROUND: Rheumatoid arthritis (RA) is associated with significantly diminished health-related quality of life. Patient-reported outcomes (PROs) are considered important in RA; however, some symptoms such as morning joint stiffness (MJS) and fatigue that are considered important by patients are not captured by the American College of Rheumatology "core set" measures for RA trials. The US Food and Drug Administration has endorsed electronic capture of clinical trial data including PROs, and electronic PRO (ePRO) systems may lead to more accurate and complete data capture, improved compliance, and patient acceptance compared with paper-based methods. Our objective was to assess the implementation of ePRO measures of Duration and Severity of MJS, Severity of Worst Tiredness, and Severity of Worst Joint Pain in baricitinib RA-BEAM and RA-BUILD phase 3 randomized clinical trials (RCTs). METHODS: A daily electronic diary (handheld device; Invivodata®, Inc.) was utilized to capture PRO data in the RCTs. Three "reporting window" options were incorporated to accommodate differences in patients' routine daily schedules, and alarms were programmed for each reporting window. Duration of MJS was recorded in "hours and minutes," and Severity of MJS, Worst Tiredness, and Worst Joint Pain were captured on a 0 to 10 rating scale, with a higher score indicating more severe symptoms. The patients and site staff were trained to use the daily electronic diary. RESULTS: Patients with moderately to severely active RA used the daily electronic diary in the RA-BEAM study (N = 1305) and RA-BUILD study (N = 684). The average compliance, calculated as total days completed by patients compared with total days expected to complete the diary, through Week 12 was high (RA-BEAM 94% patients; RA-BUILD 93% patients), potentially attributable to appropriate training, clarity of instructions, simple user interface, and electronic device design. Identified process challenges included non-timely issuance of the device, low battery, inadequate training of patients before data collection, inappropriate diary set-up, and first response entry 1 day after the baseline visit. CONCLUSIONS: High compliance rates support the use of the daily electronic PRO diary in large RCTs. Despite the anticipated issues, the daily electronic diary is expected to reduce recall bias and improve the quality of PRO data collection. TRIAL REGISTRATION: RA-BEAM ( NCT01710358 ) and RA-BUILD ( NCT01721057 ).

Critical appraisal of the recent US FDA approval for earlier DBS intervention.

In November 2015, Medtronic announced the US Food and Drug Administration (FDA) approval for the use of deep brain stimulation (DBS) therapy in people with Parkinson disease (PD) "of at least 4 years duration and with recent onset motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication." The approval was based on data from the EARLYSTIM clinical trial, a randomized, prospective, multicenter, parallel-group clinical trial in Germany and France involving 251 patients with PD. While others have reviewed the application of DBS earlier in the disease course and the results from EARLYSTIM, we focus on the conceptual, scientific, clinical, ethical, and policy issues that arise regarding the recent FDA approval.

The Impact of Spinal Needle Selection on Postdural Puncture Headache: A Meta-Analysis and Metaregression of Randomized Studies.

BACKGROUND AND OBJECTIVES: Potentially broadened indications for spinal anesthesia require increased understanding of the risk factors and prevention measures associated with postdural puncture headache (PDPH). This review is designed to examine the association between spinal needle characteristics and incidence of PDPH. METHODS: Meta-analysis and metaregression was performed on randomized controlled trials to determine the effect of needle design and gauge on the incidence of PDPH after controlling for patient confounders such as age, sex, and year of publication. RESULTS: Fifty-seven randomized controlled trials (n = 16416) were included in our analysis, of which 32 compared pencil-point design with cutting-needle design and 25 compared individual gauges of similar design. Pencil-point design was associated with a statistically significant reduction in incidence of PDPH (risk ratio, 0.41; 95% confidence interval, 0.31-0.54; P < 0.001; I = 29%) compared with cutting needles among studies that assessed both design types. Subgroup analysis among obstetric and nonobstetric procedures yielded similar results. After adjustment for significant covariates, metaregression analysis among all 57 included trials revealed a significant correlation between needle gauge and rate of PDPH among cutting needles (slope = -2.65, P < 0.001), but not pencil-point needles (slope = -0.01, P = 0.819). CONCLUSIONS: Pencil-point needles are associated with significantly lower incidence of PDPH compared with the cutting-needle design. Whereas a significant relationship was noted between needle gauge and PDPH for cutting-needle design, a similar association was not shown for pencil-point needles. Providers may consider selection of larger-caliber pencil-point needle to maximize technical proficiency without expensing increased rates of PDPH.

Tourniquet use in arthroscopic anterior cruciate ligament reconstruction: a systematic review and meta-analysis of randomised controlled trials.

BACKGROUND: To assess the effects of tourniquet use in arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. METHODS: We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) that compared surgical outcomes following tourniquet use against non-tourniquet use during ACL reconstruction surgery. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE for relevant RCTs. We used the Cochrane Collaboration's tool to assess the risk of bias of included RCTs, and performed a random-effects meta-analysis in calculating the pooled risk estimates. The primary outcomes was postoperative pain measured by visual analogue scale, verbal rating scale, or required morphine dose. The secondary outcomes were blood loss in drainage, operative time, muscle strength, and calf and thigh girth. RESULTS: We included 5 RCTs with 226 participants (116 in the tourniquet group and 110 in the non-tourniquet group). Postoperative pain and morphine doses were not significantly different between the two groups. Compared to the non-tourniquet group, the tourniquet group had a significantly increased blood loss in the drain (mean difference: 94.40 ml; 95% CI 3.65-185.14; P = 0.04). No significant differences in the operative time and muscle strength were found between the two groups. Tourniquet use was associated with a greater decrease in thigh girth but not in calf girth. CONCLUSIONS: The current evidence shows that compared to tourniquet use, ACL reconstruction surgery without tourniquet does not appear to have any major disadvantages and does not prolong operation time. There might be less drain blood loss associated with tourniquet use, though drains are no longer routinely used in ACL reconstruction surgery.

Mobile Device-Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges.

BACKGROUND: Electronic data capture (EDC) systems have been widely used in clinical research, but mobile device-based electronic data capture (mEDC) system has not been well evaluated. OBJECTIVE: The aim of our study was to evaluate the feasibility, advantages, and challenges of mEDC in data collection, project management, and telemonitoring in a randomized controlled trial (RCT). METHODS: We developed an mEDC to support an RCT called "Telmisartan and Hydrochlorothiazide Antihypertensive Treatment (THAT)" study, which was a multicenter, double-blinded, RCT, with the purpose of comparing the efficacy of telmisartan and hydrochlorothiazide (HCTZ) monotherapy in high-sodium-intake patients with mild to moderate hypertension during a 60 days follow-up. Semistructured interviews were conducted during and after the trial to evaluate the feasibility, advantage, and challenge of mEDC. Nvivo version 9.0 (QSR International) was used to analyze records of interviews, and a thematic framework method was used to obtain outcomes. RESULTS: The mEDC was successfully used to support the data collection and project management in all the 14 study hospitals. A total of 1333 patients were recruited with support of mEDC, of whom 1037 successfully completed all 4 visits. Across all visits, the average time needed for 141 questions per patient was 53 min, which were acceptable to both doctors and patients. All the interviewees, including 24 doctors, 53 patients, 1 clinical research associate (CRA), 1 project manager (PM), and 1 data manager (DM), expressed their satisfaction to nearly all the functions of the innovative mEDC in randomization, data collection, project management, quality control, and remote monitoring in real time. The average satisfaction score was 9.2 (scale, 0-10). The biggest challenge came from the stability of the mobile or Wi-Fi signal although it was not a problem in THAT study. CONCLUSIONS: The innovative mEDC has many merits and is well acceptable in supporting data collection and project management in a timely manner in clinical trial.

Clinical outcome after surgical clipping or endovascular coiling for cerebral aneurysms: a pragmatic meta-analysis of randomized and non-randomized trials with short- and long-term follow-up.

BACKGROUND: Two randomized trials have evaluated clipping and coiling in patients with ruptured aneurysms. Aggregated evidence for management of ruptured and unruptured aneurysms is missing. OBJECTIVE: To conduct a meta-analysis evaluating clinical outcome after aneurysm treatment. METHODS: PubMed, Cochrane Central Register of Controlled Trials, and Clinicaltrials.gov were searched for studies evaluating aneurysm treatment. The primary outcome measure was an independent clinical outcome (modified Rankin scale 0-2, Glasgow Outcome Scale 4-5, or equivalent). Secondary outcomes were poor outcome and mortality. ORs were calculated on an intention-to-treat basis with 95% CIs. Outcome heterogeneity was evaluated with Cochrane's Q test (significance level cut-off value at <0.10) and I2 (significance cut-off value >50%) with the Mantel-Haenszel method for dichotomous outcomes. A p value <0.05 was regarded as statistically significant. RESULTS: Searches yielded 18 802 articles. All titles were assessed, 403 abstracts were evaluated, and 183 full-text articles were read. One-hundred and fifty articles were qualitatively assessed and 85 articles were included in the meta-analysis. Patients treated with coiling (randomized controlled trials (RCTs)) had higher independent outcome at short-term follow-up (OR=0.67, 95% CI 0.57 to 0.79). Independent outcome was favored for coiling at intermediate and long-term follow-up (RCTs and observational studies combined-OR=0.80, 0.68 to 0.94 and OR=0.81, 0.71 to 0.93, respectively). Independent outcome and lower mortality was favored after coiling in unruptured aneurysms (database registry studies) at short-term follow-up (OR=0.34, 0.29 to 0.41 and OR=1.74, 1.52 to 1.98, respectively). CONCLUSIONS: This meta-analysis evaluating clinical outcome after coiling or clipping for intracranial aneurysms, indicates a higher independent outcome and lower mortality after coiling.

Coiling Is Not Superior to Clipping in Patients with High-Grade Aneurysmal Subarachnoid Hemorrhage: Systematic Review and Meta-Analysis.

BACKGROUND: Outcomes of coiling embolization versus clipping for patients with high-grade aneurysmal subarachnoid hemorrhage (aSAH) have not been previously compared. We reviewed current evidence regarding the safety and efficacy of clipping versus coiling for high-grade aSAH. METHODS: We conducted a meta-analysis of studies that compared clipping with coiling in patients with high-grade aSAH published from January 1999 to February 2016 in Medline, Embase, and Cochrane databases based on PRISMA inclusion and exclusion criteria. Binary outcome comparisons between clipping and coiling were described using odds ratios (ORs). RESULTS: Three randomized controlled trials (RCTs) and 16 observational studies were included. There was no statistical difference in good outcome rates between the clipping and coiling groups (OR, 1.44; 95% confidence interval [CI], 0.97-2.13). Subgroup analysis showed no significant difference between the 2 treatments in non-RCTs (OR, 1.49; 95% CI, 0.95-2.36) and RCTs (OR, 1.15; 95% CI, 0.59-2.25). Coiling was associated with higher mortality (OR, 0.55; 95% CI, 0.41-0.75). Lower mortality was associated with clipping in non-RCTs (OR, 0.54; 95% CI, 0.40-0.74), but there was no difference in the RCTs (OR, 0.79; 95% CI, 0.19-3.39). Coiling was not associated with lower rates of complications including rebleeding (OR, 0.62; 95% CI, 0.30-1.29), ischemic infarct (OR, 0.89; 95% CI, 0.53-1.49), symptomatic vasospasm (OR, 0.76; 95% CI, 0.45-1.29), or shunt-dependent hydrocephalus (OR, 1.33; 95% CI, 0.52-3.40). CONCLUSION: The outcome with coiling is not superior to clipping in patients with high-grade aSAH; moreover, coiling has a greater risk of mortality.

Wearables, Smartphones and Novel Anticoagulants: We Will Treat More Atrial Fibrillation, but Will Patients Be Better Off?

The widespread adoption of medical practices without a firm evidence base is common and the current growing enthusiasm for atrial fibrillation screening offers a real-time example of this phenomenon. Although no randomized trials supporting the utility of screening for atrial fibrillation exist, proponents suggest that such screening should be considered. Atrial fibrillation is a common condition that is often asymptomatic. It is also a condition associated with serious morbidity, primarily resulting from stroke. We practice at a time in which the ability to detect atrial fibrillation is becoming easier and treatments are becoming less onerous. Screening for atrial fibrillation may be beneficial but there is also a reasonable likelihood that its harms will outweigh it benefits. In this article we make the case that adopting this practice prior to data from randomized controlled trial would be a mistake. If screening for atrial fibrillation is adopted without such a robust evidence base we may well later discover that this course of action was wrong.

Non-surgical adjunctive interventions for accelerating tooth movement in patients undergoing fixed orthodontic treatment.

BACKGROUND: Accelerating the rate of tooth movement may help to reduce the duration of orthodontic treatment and associated unwanted effects including root resorption and enamel demineralisation. Several methods, including surgical and non-surgical adjuncts, have been advocated to accelerate the rate of tooth movement. Non-surgical techniques include low-intensity laser irradiation, resonance vibration, pulsed electromagnetic fields, electrical currents and pharmacological approaches. OBJECTIVES: To assess the effect of non-surgical adjunctive interventions on the rate of orthodontic tooth movement and the overall duration of treatment. SEARCH METHODS: We searched the following databases on 25 November 2014: the Cochrane Oral Health Group's Trials Register (November 2014), the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library 2014, Issue 10), MEDLINE via OVID (1946 to November 2014), EMBASE via OVID (1980 to November 2014), LILACS via BIREME (1980 to November 2014), metaRegister of Controlled Trials (November 2014), the US National Institutes of Health Trials Register (ClinicalTrials.gov; November 2014) and the WHO International Clinical Trials Registry Platform (November 2014). We checked the reference lists of all trials identified for further studies. There were no restrictions regarding language or date of publication in the searches of the electronic databases. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of people receiving orthodontic treatment using fixed appliances along with non-surgical adjunctive interventions to accelerate tooth movement. We excluded non-parallel design studies (for example, split-mouth) as we regarded them as inappropriate for assessment of the effects of this type of intervention. DATA COLLECTION AND ANALYSIS: Two review authors were responsible for study selection, risk of bias assessment and data extraction; they carried out these tasks independently. Any disagreements were resolved by discussion amongst the review team to reach consensus. The review authors contacted the corresponding authors of trials to obtain missing information and data to allow calculation of mean differences (MD), 95% confidence intervals (CI) or risk ratios (RR) when these were not reported. MAIN RESULTS: We included two studies in this review, which were both assessed as being at high risk of bias. The two studies, involving a total of 111 participants, compared the use of Tooth Masseuse and OrthoAccel with conventional treatment mechanics during orthodontic alignment and canine retraction phases, respectively. Both studies included objective assessment of the amount or rate of tooth movement, but we were not able to meta-analyse this data as they used different outcome measurements at different stages of the orthodontic treatment process. One study measured subjective evaluation of pain and discomfort and the other evaluated adverse effects. The studies did not directly report either the duration of orthodontic treatment or the number of visits during active treatment.Using the Tooth Masseuse with 111 Hz at 0.06 Newtons (N) for 20 minutes daily resulted in greater reduction in irregularity in the lower incisor region over 10 weeks, assessed using Little's Irregularity Index (LII) with a mean difference (MD) of 0.6 mm (95% confidence interval (CI) -0.94 to 2.34) when compared to the control group. Pain and discomfort increased at six to eight hours after arch wire placement and after seven days, with minimal difference between the intervention and control groups. No statistical tests were provided for either variable and the differences between the two groups were not clinically important.Using OrthoAccel with 30 Hz at 0.25 N for 20 minutes daily produced a higher rate of maxillary canine distalisation in comparison to the control group (MD 0.37 mm/month; 95% CI -0.07 to 0.81; P = 0.05). Whilst this difference suggested 50% faster tooth movement using the vibrational appliance, the absolute differences were marginal and deemed clinically unimportant. Similar levels of non-serious adverse effects were reported in the intervention and control groups with a risk ratio of 0.96 (95% CI 0.32 to 2.85).Overall, the quality of the evidence was very low and therefore we cannot rely on the findings. AUTHORS' CONCLUSIONS: There is very little clinical research concerning the effectiveness of non-surgical interventions to accelerate orthodontic treatment. The available evidence is of very low quality and so it is not possible to determine if there is a positive effect of non-surgical adjunctive interventions to accelerate tooth movement. Although there have been claims that there may be a positive effect of light vibrational forces, results of the current studies do not reach either statistical or clinical significance. Further well-designed and rigorous RCTs with longer follow-up periods are required to determine whether non-surgical interventions may result in a clinically important reduction in the duration of orthodontic treatment, without any adverse effects.

Performance of an Electronic Diary System for Intensive Insulin Management in Global Diabetes Clinical Trials.

BACKGROUND: This report describes the performance of a wireless electronic diary (e-diary) system for data collection and enhanced patient-investigator interactions during intensive insulin management in diabetes clinical trials. MATERIALS AND METHODS: We implemented a customized electronic communication system featuring an e-diary and a Web portal in three global, randomized, controlled Phase 3 clinical trials testing basal insulin peglispro compared with insulin glargine, both combined with prandial insulin lispro, in patients with type 1 or type 2 diabetes mellitus (T1DM and T2DM, respectively). We collected data during 28 weeks of study e-diary use for the report. RESULTS: Patients (n=2,938) in 31 countries used e-diaries to transmit 2,439,087 blood glucose (BG) values, 96% of which were associated by the patient with a protocol time point during the 72-h response window. Of 208,192 hypoglycemia events captured, 96% had a BG value, and 95% had treatments and outcomes entered by patients within the 72-h window. Patients recorded administration of 1,964,477 insulin doses; 93% of basal insulin doses were adherent with the investigator prescription. Investigators adjusted 13 basal and 92 bolus insulin prescriptions per patient-year using the e-diary system. After 26 weeks of treatment and e-diary use in the combined study arms, hemoglobin A1c values decreased by 0.6% or 1.6% and fasting BG decreased by 7.8 or 28 mg/dL in patients with T1DM or T2DM, respectively. CONCLUSIONS: The e-diary system enabled comprehensive data collection and facilitated communication between investigators and patients for intensive insulin management in three global clinical trials testing basal insulins.

Including auxiliary item information in longitudinal data analyses improved handling missing questionnaire outcome data.

OBJECTIVES: Previous studies show that missing values in multi-item questionnaires can best be handled at item score level. The aim of this study was to demonstrate two novel methods for dealing with incomplete item scores in outcome variables in longitudinal studies. The performance of these methods was previously examined in a simulation study. The two methods incorporate item information at the background when simultaneously the study outcomes are estimated. STUDY DESIGN AND SETTING: The investigated methods include the item scores or a summary of a parcel of available item scores as auxiliary variables while using the total score of the multi-item questionnaire as the main focus of the analysis in a latent growth model. That way the items help estimating the incomplete information of the total scores. The methods are demonstrated in two empirical data sets. RESULTS: Including the item information results in more precise outcomes in terms of regression coefficient estimates and standard errors, compared with not including item information in the analysis. CONCLUSION: The inclusion of a parcel summary is an efficient method that does not overcomplicate longitudinal growth estimates. Therefore, it is recommended in situations where multi-item questionnaires are used as outcome measure in longitudinal clinical studies with incomplete scores because of missing item scores.

The Use of Technology in Participant Tracking and Study Retention: Lessons Learned From a Clinical Trials Network Study.

BACKGROUND: The growing use of newer communication and Internet technologies, even among low-income and transient populations, require research staff to update their outreach strategies to ensure high follow-up and participant retention rates. This paper presents the views of research assistants on the use of cell phones and the Internet to track participants in a multisite randomized trial of substance use disorder treatment. METHODS: Preinterview questionnaires exploring tracking and other study-related activities were collected from 21 research staff across the 10 participating US sites. Data were then used to construct a semistructured interview guide that, in turn, was used to interview 12 of the same staff members. The questionnaires and interview data were entered in Atlas.ti and analyzed for emergent themes related to the use of technology for participant-tracking purposes. RESULTS: Study staff reported that most participants had cell phones, despite having unstable physical addresses and landlines. The incoming call feature of most cell phones was useful for participants and research staff alike, and texting proved to have additional benefits. However, reliance on participants' cell phones also proved problematic. Even homeless participants were found to have access to the Internet through public libraries and could respond to study staff e-mails. Some study sites opened generic social media accounts, through which study staff sent private messages to participants. However, the institutional review board (IRB) approval process for tracking participants using social media at some sites was prohibitively lengthy. Internet searches through Google, national paid databases, obituaries, and judiciary Web sites were also helpful tools. CONCLUSIONS: Research staff perceive that cell phones, Internet searches, and social networking sites were effective tools to achieve high follow-up rates in drug abuse research. Studies should incorporate cell phone, texting, and social network Web site information on locator forms; obtain IRB approval for contacting participants using social networking Web sites; and include Web searches, texting, and the use of social media in staff training as standard operating procedures.

Semantic primes theory may be helpful in designing questionnaires such as to prevent response shift.

OBJECTIVES: The purpose of randomized control trials (RCTs) can be the assessment of the direct effect of treatment on health-related quality of life (HRQL). Response shift (RS) theory considers that a change in HRQL scores observed over time cannot be explained solely by a direct effect of a medical condition, it may also result from a change in the way people appraise their HRQL. The RS effect is a potential bias that is liable to compromise efficient assessment of the effect of treatment on HRQL. STUDY DESIGN AND SETTING: We hypothesize a link between the RS effect on HRQL scores and the level of complexity of HRQL conceptualization. RESULTS: We discuss how the impact of reconceptualization on scores depends on the complexity of the linguistic definition of a subjective construct and how for reprioritization the impact depends on the dimensionality. The linguistic theory of semantic primes is used to help identify how subjective constructs can be classified according to the complexity of their definitions. CONCLUSION: Finally, we suggest that the impact of the RS effect on HRQL scores could be avoided (or lessened) if questionnaires were designed with a rule of "the least semantic and psychometric complexity" in mind.

Comparison of the effects of magnesium sulphate and dexmedetomidine on surgical vision quality in endoscopic sinus surgery: randomized clinical study / Comparação dos efeitos de sulfato de magnésio e da dexmedetomidina sobre a qualidade da visibilidade em cirurgia endoscópica sinusal: estudo clínico randomizado / Comparación de los efectos de sulfato de magnesio y dexmedetomidina sobre la calidad de la visibilidad en cirugía endoscópica sinusal: estudio clínico aleatorizado

Background and objectives: Even a small amount of bleeding during endoscopic sinus surgery can corrupt the endoscopic field and complicate the procedure. Various techniques, including induced hypotension, can minimize bleeding during endoscopic sinus surgery. The aim of this study was to compare the surgical vision quality, haemodynamic parameters, postoperative pain, and other effects of magnesium, a hypotensive agent, with that of dexmedetomidine, which was initially developed for short-term sedation in the intensive care unit but also is an alpha 2 agonist sedative. Method: 60 patients between the ages of 18 and 45 years were divided into either the magnesium group (Group M) or the dexmedetomidine group (Group D). In Group M, magnesium sulphate was given at a pre-induction loading dose of 50 mg kg−1 over 10 min and maintained at 15 mg kg−1 h−1; in Group D, dexmedetomidine was given at 1 mcg kg−1 10 min before induction and maintained at 0.6 mcg kg−1 h−1. Intraoperatively, the haemodynamic and respiratory parameters and 6-point intraoperative surgical field evaluation scale were recorded. During the postoperative period, an 11-point numerical pain scale, the Ramsay sedation scale, the nausea/vomiting scale, the adverse effects profile, and itching parameters were noted. Results: Group D showed a significant decrease in intraoperative surgical field evaluation scale scale score and heart rate. The average operation time was 50 min, and Group M had a higher number of prolonged surgeries. No significant difference was found in the other parameters. Conclusions: Due to its reduction of bleeding and heart rate in endoscopic sinus surgery and its positive impacts on the duration of surgery, we consider dexmedetomidine to be a good alternative to magnesium. .

Justificativa e objetivo: Uma quantidade, mesmo pequena, de sangramento durante a cirurgia endoscópica pode alterar o campo endoscópico e dificultar o procedimento. Várias técnicas, incluindo hipotensão induzida, podem minimizar o sangramento durante a cirurgia endoscópica. O objetivo deste estudo foi comparar a qualidade da visibilidade cirúrgica, os parâmetros hemodinâmicos, a dor no período pós-operatório e outros efeitos do sulfato de magnésio, um agente hipotensor, com os da dexmedetomidina, inicialmente desenvolvida para sedação em curto prazo em unidade de terapia intensiva, mas que também é um sedativo agonista alfa-2. Métodos: Foram alocados 60 pacientes entre 18 e 45 anos em dois grupos: Grupo M (magnésio) e Grupo D (dexmedetomidina). No Grupo M, sulfato de magnésio foi administrado pré-indução a uma dose de carga de 50 mg kg−1 por 10 minutos e mantida com 15 mg kg−1 h−1; no Grupo D, dexmedetomidina foi administrada a uma dose de 1 mcg kg−1 10 minutos antes da indução e mantida com 0,6 mcg kg−1 h−1. No período intraoperatório, foram registrados os parâmetros hemodinâmicos e respiratórios e a avaliação do campo cirúrgico com uma escala de seis pontos. Durante o período pós-operatório foram registrados os valores da escala numérica de 11 pontos para avaliar a dor, a escala de sedação de Ramsay, a escala de avaliação de náusea/vômito, o perfil dos efeitos adversos e pruridos. Resultados: O Grupo D apresentou redução significativa da frequência cardíaca e do escore na escala de avaliação do campo cirúrgico intraoperatório. A média do tempo cirúrgico foi de 50 minutos e o Grupo M apresentou um número maior de cirurgias prolongadas. ...

Introducción y objetivo: Una cantidad, aunque sea pequeña, de sangrado durante la cirugía endoscópica puede alterar el campo endoscópico y dificultar el procedimiento. Varias técnicas que incluyen hipotensión inducida pueden minimizar el sangrado durante la cirugía endoscópica. El objetivo de este estudio fue comparar la calidad de la visibilidad quirúrgica, los parámetros hemodinámicos, el dolor en el período postoperatorio y otros efectos del sulfato de magnesio, que es un agente hipotensor, con los de la dexmedetomidina, inicialmente desarrollada para la sedación a corto plazo en la unidad de cuidados intensivos, pero que también es un sedante agonista alfa-2. Método: 60 pacientes con edades entre 18 y 45 años se dividieron en 2 grupos: grupo M (magnesio) y grupo D (dexmedetomidina). En el grupo M, el sulfato de magnesio fue administrado antes de la inducción en dosis de carga de 50 mg kg−1 por 10 min y se mantuvo con 15 mg kg−1 h−1; en el grupo D, la dexmedetomidina fue administrada con una dosis de 1 µg kg−1 durante 10 min antes de la inducción y se mantuvo con 0,6 µg kg−1 h−1. En el período intraoperatorio se registraron los parámetros hemodinámicos y respiratorios y la evaluación del campo quirúrgico con una escala de 6 puntos. Durante el postoperatorio también se registraron la escala numérica de 11 puntos para evaluar el dolor, la escala de sedación de Ramsay, la escala de evaluación de náuseas/vómito, el perfil de los efectos adversos y los pruritos. Resultados: El grupo D tuvo una reducción significativa de la frecuencia cardíaca y de la puntuación en la escala de evaluación del campo quirúrgico intraoperatorio. La media del tiempo quirúrgico fue de 50 min, y el grupo M tuvo un número mayor de ...

Leukodepletion for patients undergoing heart valve surgery.

BACKGROUND: There is some evidence for the benefits of leukodepletion in patients undergoing coronary artery surgery. Its effectiveness in higher risk patients, such as those undergoing heart valve surgery, particularly in terms of overall clinical outcomes, is currently unclear. OBJECTIVES: To assess the beneficial and harmful effects of leukodepletion on clinical, patient-reported and economic outcomes in patients undergoing heart valve surgery. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 3 of 12) in The Cochrane Library, the NHS Economic Evaluations Database (1960 to April 2013), MEDLINE Ovid (1946 to April week 2 2013), EMBASE Ovid (1947 to Week 15 2013), CINAHL (1982 to April 2013) and Web of Science (1970 to 17 April 2013) on 19 April 2013. We also searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), the US National Institutes of Health (NIH) clinical trials database and the International Standard Randomised Controlled Trial Number Register (ISRCTN) in April 2013 for ongoing studies. No language or time period restrictions were applied. We examined the reference lists of all included randomised controlled trials and contacted authors of identified trials. We searched the 'grey' literature at OpenGrey and handsearched relevant conference proceedings. SELECTION CRITERIA: Randomised controlled trials comparing a leukocyte-depleting arterial line filter with a standard arterial line filter, on the arterial outflow of the heart-lung bypass circuit, in elective patients undergoing heart valve surgery. DATA COLLECTION AND ANALYSIS: Data were collected on the study characteristics, three primary outcomes (1. post-operative in-hospital all-cause mortality within three months, 2. post-operative all-cause mortality excluding inpatient mortality < 30 days, 3. length of stay in hospital, 4. adverse events and serious adverse events) and seven secondary outcomes (1. tubular or glomerular kidney injury, 2. validated health-related quality of life scales, 3. validated renal injury scales, 4. use of continuous veno-venous haemo-filtration, 5. length of stay in intensive care, 6. costs of care). Data were extracted by one author and verified by a second author. Insufficient data were available to perform a meta-analysis or sensitivity analysis. MAIN RESULTS: Eight studies were eligible for inclusion in the review but data on prespecified review outcomes were available from only one, modestly powered (24 participants) study (Hurst 1997). There were no differences between a leuko-depleting versus standard filter in length of stay in the intensive care unit (ICU) (mean difference (MD) 0.80 days; 95% confidence interval (CI) -0.24 to 1.84) or length of hospital stay (MD 0.20 days; 95% CI -1.78 to 2.18). AUTHORS' CONCLUSIONS: There are currently insufficient good quality trials with valve surgery patients to inform recommendations for changes in clinical practice. A future National Institute for Health Research (NIHR)-funded feasibility study (recruiting mid-year 2013) comparing leukodepletion with a standard arterial line filter in patients undergoing elective heart valve surgery (the ROLO trial) will be the largest study to date and will make a significant contribution to future updates of this review.