Good Quality Randomised Controlled Trials Research Articles

Smartphone applications are used for self-management, telerehabilitation, evaluation and data collection in low back pain healthcare: a scoping review

Background Smartphone use has grown in providing healthcare for patients with low back pain (LBP), but the literature lacks an analysis of the use of smartphone apps. This scoping review aimed to identify current areas of smartphone apps use for managing LBP. We also aimed to evaluate the current status of the effectiveness or scientific validity of such use and determine perspectives for their potential development. Methods We searched PubMed, PEDro and Embase for articles published in English up to May 3rd, 2021 that investigated smartphone use for LBP healthcare and their purpose. All types of study design were accepted. Studies concerning telemedicine or telerehabilitation but without use of a smartphone were not included. The same search strategy was performed by two researchers independently and a third researcher validated the synthesis of the included studies. Results We included 43 articles: randomised controlled trials (RCTs) (n=12), study protocols (n=6), reliability/validity studies (n=6), systematic reviews (n=7), cohort studies (n=4), qualitative studies (n=6), and case series (n=1). The purposes of the smartphone app were for 1) evaluation, 2) telerehabilitation, 3) self-management, and 4) data collection. Self-management was the most-studied use, showing promising results derived from moderate- to good-quality RCTs for patients with chronic LBP and patients after spinal surgery. Promising results exist regarding evaluation and data collection use and contradictory results regarding measurement use. Conclusions This scoping review revealed a notable interest in the scientific literatures regarding the use of smartphone apps for LBP patients. The identified purposes point to current scientific status and perspectives for further studies including RCTs and systematic reviews targeting specific usage.

Laser de alta potência no tratamento da pigmentação gengival: uma revisão integrativa da literatura

ABSTRACT Objective: To perform an integrative literature review about effectiveness of high-power laser in the treatment of gingival melanin pigmentation. Methods: This research consists of an integrative review conducted from September 2021 to May 2022 seeking to answer the following question: “What is the clinical effectiveness of laser in the treatment of gingival melanin pigmentation?”. The articles were analyzed by two researchers and the information about these was collected with emphasis on the following data: authors, year of publication, study objectives, methodology, results and conclusion. Results: Of the 16 articles initially selected, 08 were excluded (3 literature reviews, 4 internship reports and 1 monography). Thus, 8 articles were selected. Conclusion: Among several types of lasers and techniques for its use, laser, especially diode laser, was the most used technique and presented better aesthetic results, less pain, faster healing, preference and patient satisfaction after treatment. More good quality randomized control trials are needed in different techniques currently used to generate conclusions with high scientific evidence.

Post-surgery interventions for hip fracture: a systematic review of randomized controlled trials

BackgroundInterventions provided after hip fracture surgery have been shown to reduce mortality and improve functional outcomes. While some systematic studies have evaluated the efficacy of post-surgery interventions, there lacks a systematically rigorous examination of all the post-surgery interventions which allows healthcare providers to easily identify post-operative interventions most pertinent to patient’s recovery.ObjectivesWe aim to provide an overview of the available evidence on post-surgery interventions provided in the acute, subacute and community settings to improve outcomes for patients with hip fractures.MethodsWe performed a systematic literature review guided by the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA). We included articles that were (1) randomized controlled trials (RCTs), (2) involved post-surgery interventions that were conducted in the acute, subacute or community settings and (3) conducted among older patients above 65 years old with any type of non-pathological hip fracture that was surgically treated, and who were able to walk without assistance prior to the fracture. We excluded (1) non–English language articles, (2) abstract-only publications, (3) articles with only surgical interventions, (4) articles with interventions that commenced pre-surgery or immediately upon completion of surgery or blood transfusion, (5) animal studies. Due to the large number of RCTs identified, we only included “good quality” RCTs with Jadad score ≥ 3 for data extraction and synthesis.ResultsOur literature search has identified 109 good quality RCTs on post-surgery interventions for patients with fragility hip fractures. Among the 109 RCTs, 63% of the identified RCTs (n = 69) were related to rehabilitation or medication/nutrition supplementation, with the remaining RCTs focusing on osteoporosis management, optimization of clinical management, prevention of venous thromboembolism, fall prevention, multidisciplinary approaches, discharge support, management of post-operative anemia as well as group learning and motivational interviewing. For the interventions conducted in inpatient and outpatient settings investigating medication/nutrition supplementation, all reported improvement in outcomes (ranging from reduced postoperative complications, reduced length of hospital stay, improved functional recovery, reduced mortality rate, improved bone mineral density and reduced falls), except for a study investigating anabolic steroids. RCTs involving post-discharge osteoporosis care management generally reported improved osteoporosis management except for a RCT investigating multidisciplinary post-fracture clinic led by geriatrician with physiotherapist and occupational therapist. The trials investigating group learning and motivational interviewing also reported positive outcome respectively. The other interventions yielded mixed results. The interventions in this review had minor or no side effects reported.ConclusionsThe identified RCTs regarding post-surgery interventions were heterogeneous in terms of type of interventions, settings and outcome measures. Combining interventions across inpatient and outpatient settings may be able to achieve better outcomes such as improved physical function recovery and improved nutritional status recovery. For example, nutritional supplementation could be made available for patients who have undergone hip fracture surgery in the inpatient settings, followed by post-discharge outpatient osteoporosis care management. The findings from this review can aid in clinical practice by allowing formulation of thematic program with combination of interventions as part of bundled care to improve outcome for patients who have undergone hip fracture surgery.

Vitamin D Supplementation and Its Impact on Mortality and Cardiovascular Outcomes: Systematic Review and Meta-Analysis of 80 Randomized Clinical Trials.

The impact of vitamin D supplementation on cardiovascular outcomes and mortality risk reduction remains unclear due to conflicting study findings. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs), published between 1983 and 2022, that reported the effect of vitamin D supplementation in adults versus placebo or no treatment on all-cause mortality (ACM), cardiovascular mortality (CVM), non-cardiovascular mortality (non-CVM), and cardiovascular morbidities. Only studies with a follow-up period longer than one year were included. The primary outcomes were ACM and CVM. Secondary outcomes were non-CVM, myocardial infarction, stroke, heart failure, and major or extended adverse cardiovascular events. Subgroup analyses were performed according to low-, fair- and good-quality RCTs. Eighty RCTs were assessed, including 82,210 participants receiving vitamin D supplementation and 80,921 receiving placebo or no treatment. The participants' mean (SD) age was 66.1 (11.2) years, and 68.6% were female. Vitamin D supplementation was associated with a lower risk of ACM (OR: 0.95 [95%CI 0.91-0.99] p = 0.013), was close to statistical significance for a lower risk of non-CVM (OR: 0.94 [95%CI 0.87-1.00] p = 0.055), and was not statistically associated with a lower risk of any cardiovascular morbi-mortality outcome. Meta-analysis of low-quality RCTs showed no association with cardiovascular or non-cardiovascular morbi-mortality outcomes. The emerging results of our meta-analysis present evidence that vitamin D supplementation appears to decrease the risk of ACM (especially convincing in the fair- and good-quality RCTs), while not showing a decrease in the specific cardiovascular morbidity and mortality risk. Thus, we conclude that further research is warranted in this area, with well-planned and executed studies as the basis for more robust recommendations.

A systematic review and meta-analysis of neuromodulators to treat chronic airway hypersensitivity

ObjectivesChronic laryngitis can present with numerous symptoms, including chronic cough. Patients who do not respond to standard treatment are sometimes diagnosed with chronic airway hypersensitivity (CAH). In many centers, neuromodulators are prescribed off-label despite limited evidence of efficacy. A previous meta-analysis suggested neuromodulator therapy improved cough-related quality-of-life (QoL). This current updated and expanded meta-analysis examined whether neuromodulators reduced cough frequency, reduced cough severity, and/or improved QoL in CAH patients. Data sourcesPubMed, Embase, Medline, Cochrane Review, and publication bibliographies were searched from 01/01/2000 to 07/31/2021 using MESH terms. Review methodsPRISMA guidelines were followed. 999 abstracts were identified/screened, 28 studies were fully reviewed, and 3 met inclusion criteria. Only randomized controlled trials (RCT) investigating CAH patients with comparable cough-related outcomes were included. Three authors reviewed potentially eligible papers. Fixed-effect models and calculated pooled estimates using the Inverse-Variance method were used. ResultsThe estimated difference in change in log coughs per hour (from baseline to intervention end) between treatment and control groups was −0.46, 95%CI [−0.97; 0.05]. Estimated change-from-baseline in VAS scores was −12.24, 95 % CI [−17.84; −6.65] lower for patients who received treatment vs placebo. Estimated change-from-baseline for LCQ scores was 2.15, 95 % CI [1.49–2.80] higher for patients who receive treatment vs placebo. Only change in LCQ score was clinically significant. ConclusionsThis study tentatively suggests that neuromodulators have the potential to reduce cough symptoms associated with CAH. However, high-quality evidence is lacking. This could be due to limited treatment effect or significant limitations in the design and comparability of existing trials. A well-designed and properly powered RCT is needed to authoritatively test the efficacy of neuromodulators for the treatment of CAH. Level of evidenceLevel I, evidence from a systematic review or meta-analysis of all relevant RCTs (randomized controlled trial) or evidence-based clinical practice guidelines based on systematic reviews of RCTs or three or more RCTs of good quality that have similar results.

The Effect of Probiotic and Synbiotic Consumption on the Most Prevalent Chemotherapy-related Complications: A Systematic Review of Current Literature.

To date, many investigations have employed pro-/synbiotic to examine their effects on chemotherapy-related side effects; nevertheless, their findings are inconclusive. To address this issue, we carried out a systematic review to explore the effect of pro- /synbiotic consumption on chemotherapy-related side effects, including nausea, vomiting, mucositis, diarrhea, and constipation in adults using randomized controlled trials (RCTs). The electronic databases, including PubMed, Scopus, and ISI Web of Sciences, were searched systematically from the earliest available date to March 2021 to identify eligible studies. The quality of the enrolled studies was assessed based on the Cochrane Collaboration Risk of Bias tool. A total of 10 studies involving 788 individuals were included in the current systematic review, with the sample size ranging from 25 to 200 and the mean age ranging from 51.04 to 66.91 years. The findings of this study imply that probiotic consumption may be more effective in terms of mucositis compared to other complications. Further good-quality RCTs with better methodology are required to determine whether and how pro-/synbiotics can prevent or treat chemotherapy-induced side effects. The current systematic review findings may help investigators of future studies in selecting the study population and probiotic strains.

Smartphone applications are used for self-management, telerehabilitation, evaluation and data collection in low back pain healthcare: a scoping review

Background: Technological developments have accelerated notably in the field of telecommunications in the last few decades. Smartphone use has grown in providing healthcare for patients with low back pain (LBP), but the literature lacks an analysis of the use of smartphone apps. This scoping review aimed to identify current areas of smartphone apps use for managing LBP. We also aimed to evaluate the current status of the effectiveness or scientific validity of such use and determine perspectives for their potential development. Methods: We searched PubMed, PEDro and Embase for articles published in English up to May 3rd, 2021 that investigated smartphone use for LBP healthcare and their purpose. All types of study design were accepted. Studies concerning telemedicine or telerehabilitation but without use of a smartphone were not included. The same search strategy was performed by two researchers independently and a third researcher validated the synthesis of the included studies. Results: We included 43 articles: randomised controlled trials (RCTs) (n=12), study protocols (n=6), reliability/validity studies (n=6), systematic reviews (n=7), cohort studies (n=4), qualitative studies (n=6), and case series (n=1). The purposes of the smartphone app were for 1) evaluation, 2) telerehabilitation, 3) self-management, and 4) data collection. Self-management was the most-studied use, showing promising results derived from moderate- to good-quality RCTs for patients with chronic LBP and patients after spinal surgery. Promising results exist regarding evaluation and data collection use and contradictory results regarding measurement use. Conclusions: This scoping review revealed a growing scientific literature regarding the use of smartphone apps for LBP patients. The identified purposes point to current scientific status and perspectives for further studies including RCTs and systematic reviews targeting specific usage. Caution should be taken to monitor the impact of smartphone-related compulsive behaviour.

Pulsatile Perfusion during Cardiopulmonary Bypass: A Literature Review.

The use of cardiopulmonary bypass (CPB) in cardiac surgery has often been associated with postoperative organ dysfunction. Roller and centrifugal pumps produce non-pulsatile flow (NPF) by default, and this still is the most widely used mode of perfusion. The development of pulsatile pumps has allowed comparisons to be made with NPF. Pulsatile flow (PF) mimics the arterial pulse generated by the heart and is thought to be more physiological by some. This review aims to examine the proposed mechanisms behind the potential physiological benefits of PF during CPB and to summarize the current clinical evidence. MEDLINE and EMBASE were used to identify articles published over a 25 year period from 1995 to 2020. A literature review was conducted to determine the effects of PF on organ functions. A total of 44 articles were considered. Most of the articles published on PF were randomized controlled trials (RCTs). However, there was a wide variation in study methodology, method of pulse generation and how pulsatility was measured. Most of the evidence in favor of PF showed a marginal improvement on renal and pulmonary outcomes. In these studies, pulsatility was generated by an intra-aortic balloon pump. In conclusion, there is a lack of good quality RCTs that can inform on the short- and long-term clinical outcomes of PF. Further research is required in order to draw a conclusion with regards to the benefits of PF on organ function.

Short-term Effect of Noninvasive Brain Stimulation Techniques on Motor Impairment in Chronic Ischemic Stroke: A Systematic Review with Meta-Analysis.

In recent years, noninvasive brain stimulation (NIBS) has shown promise for stroke rehabilitation as a novel nonpharmaceutical neuromodulatory intervention with attractive neurophysiological theories backing it up. To find out the short-term effects of NIBS techniques on motor impairment in chronic ischemic stroke. A systematic review with meta-analysis was performed separately for transcranial direct current stimulation (tDCS), transcranial magnetic stimulation (TMS), and studies that combined both, utilizing various databases for a period spanning from 2001 to 2019. Good-quality randomized controlled trials (RCTs) on chronic ischemic stroke cases with homogeneous clinical upper motor short-term outcome measures were considered for the meta-analysis. RevMan 5.1 software was used for the meta-analysis. Meta-analysis registration: CRD42021196299; https://www.crd.york.ac.uk/PROSPERO. A total of 319 studies were identified initially. After necessary filters to comply with the strict recruitment criteria, only four studies qualified, two each for tDCS and TMS and none qualified for analysis under the combined category. tDCS showed a nonsignificant effect on the upper limb motor function improvement (-0.10 [95% confidence interval {CI}: -0.84 to 0.64; I2 0%; P = 0.8]), whereas the repetitive TMS showed a significant effect (0.75 [95% CI: 0.03-1.48; I2 0%; P = 0.04]). The safety analysis did not reveal any major concerns for several published protocols. tDCS alone did not significantly benefit motor recovery; rTMS was effective in providing immediate functional benefits in chronic ischemic stroke. While the current stroke rehabilitation protocols with NIBS appear safe, more good-quality stratified RCTs with more innovative experimental protocols are needed to analyze and quantify the efficacy of these techniques in stroke rehabilitation.

On Framing the Research Question and Choosing the Appropriate Research Design.

Clinical epidemiology is the science of human disease investigation with a focus on diagnosis, prognosis, and treatment. The generation of a reasonable question requires definition of patients, interventions, controls, and outcomes. The goal of research design is to minimize error, ensure adequate samples, measure input and output variables appropriately, consider external and internal validities, limit bias, and address clinical as well as statistical relevance. The hierarchy of evidence for clinical decision-making places randomized controlled trials (RCT) or systematic review of good-quality RCTs at the top of the evidence pyramid. Prognostic and etiologic questions are best addressed with longitudinal cohort studies.

INTERVENTION FOR OCCUPATIONAL FATIGUE AND SLEEPINESS AMONG HEALTHCARE WORKERS WORKING IN SHIFT: A SYSTEMATIC REVIEW

Healthcare workers typically work in shift to ensure smooth operation of healthcare industries around the clock. However, working in shift put them at risk of developing occupational fatigue and sleepiness during and after work, with multiple adverse effects to themselves and patients under their care. This review aims to identify available evidence-based intervention for fatigue and sleepiness among healthcare workers working in shift. We searched PubMed, Scopus and CENTRAL database from January 2013 to December 2017. Selection criteria included randomised controlled trials (RCTs) that investigated the effect of any interventions on fatigue and/or sleepiness among shift workers. Two authors independently screened titles and abstracts for relevant studies, extracted data, and assessed risk of bias. We included 8 relevant trials with 7 review-relevant participants. Given the methodological diversity of the included studies in terms of interventions and assessment tools, it is not possible to determine the effectiveness of these interventions to reduce occupational fatigue or sleepiness among healthcare workers working in shift. More good quality RCTs with comparable assessment tools is needed.

Vascular access specialist teams for device insertion and prevention of failure.

Most people admitted to hospitals worldwide require a vascular access device (VAD). Hundreds of millions of VADs are inserted annually in the USA with reports of over a billion peripheral intravenous catheters used annually worldwide. Numerous reports suggest that a team approach for the assessment, insertion, and maintenance of VADs improves clinical outcomes, the patient experience, and healthcare processes. To compare the use of the vascular access specialist team (VAST) for VAD insertion and care to a generalist model approach for hospital or community participants requiring a VAD in terms of insertion success, device failure, and cost-effectiveness. We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 1); Ovid MEDLINE (1950 to 7 February 2018); Ovid Embase (1980 to 7 February 2018); EBSCO CINAHL (1982 to 7 February 2018); Web of Science Conference Proceedings Citation Index - Science and Social Science and Humanities (1990 to 7 February 2018); and Google Scholar. We searched the following trial registries: Australian and New Zealand Clinical Trials Register (www.anzctr.org.au); ClinicalTrials.gov (www.clinicaltrials.gov); Current Controlled Trials (www.controlled-trials.com/mrct); HKU Clinical Trials Registry (www.hkclinicaltrials.com); Clinical Trials Registry - India (ctri.nic.in/Clinicaltrials/login.php); UK Clinical Trials Gateway (www.controlled-trials.com/ukctr/); and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) (www.who.int/trialsearch). We searched all databases on 7 February 2018. We planned to include randomized controlled trials (RCTs) that evaluated the effectiveness of VAST or specialist inserters for their impact on clinical outcomes. We used standard methodological procedures recommended by Cochrane and used Covidence software to assist with file management. We retrieved 2398 citations: 30 studies were eligible for further examination of their full text, and we found one registered clinical trial in progress. No studies could be included in the analysis or review. We assigned one study as awaiting classification, as it has not been accepted for publication. This systematic review failed to locate relevant published RCTs to support or refute the assertion that vascular access specialist teams are superior to the generalist model. A vascular access specialist team has advanced knowledge with regard to insertion techniques, clinical care, and management of vascular access devices, whereas a generalist model comprises nurses, doctors, or other designated healthcare professionals in the healthcare facility who may have less advanced insertion techniques and who care for vascular access devices amongst other competing clinical tasks. However, this conclusion may change once the one study awaiting classification and one ongoing study are published. There is a need for good-quality RCTs to evaluate the efficacy of a vascular access specialist team approach for vascular access device insertion and care for the prevention of failure.

Acupuncture and Related Therapies for Treatment of Postoperative Ileus in Colorectal Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Delays in recovery of intestinal function following abdominal surgery are associated with longer hospital stays, increased postoperative complications, and higher costs to the health care system. Studies of acupuncture for postoperative ileus and other postoperative issues have reported improvements. This systematic review and meta-analysis aimed to assess whether acupuncture assisted recovery following surgery for colorectal cancer (CRC). Randomized controlled trials (RCTs) were identified from major English and Chinese language biomedical databases. Participants (aged 18 years plus) had received surgical resection for CRC. 22 studies (1,628 participants) were included. Five were sham-controlled. Outcomes included gastrointestinal function recovery (21 studies), recovery of urinary function (1 study), postoperative abdominal distension (3 studies), and quality of life (1 study). Meta-analyses found significant reductions in time to first bowel sounds, first flatus, and first defecation in both the sham-controlled and nonblinded studies. These results suggested that the addition of acupuncture following CRC surgery improved recovery of gastrointestinal function based on four blinded good quality RCTs (281 participants) and 17 nonblinded lower quality RCTs (1,265 participants). The best available evidence was for interventions that included electroacupuncture at the point ST36 Zusanli and there is supporting evidence for other types of acupuncture therapies that involve stimulation of this point. This review is registered with the following: systematic review registration in PROSPERO: CRD42017079590.

Effects of calcium on the incidence of recurrent colorectal adenomas: A systematic review with meta-analysis and trial sequential analysis of randomized controlled trials.

Protective effects of calcium supplementation against colorectal adenomas have been documented in systematic reviews; however, the results have not been conclusive. Our objective was to update and systematically evaluate the evidence for calcium supplementation taking into consideration the risks of systematic and random error and to GRADE the evidence. The study comprised a systematic review with meta-analysis and trial sequential analysis (TSA) of randomized controlled trials (RCTs). We searched for RCTs published up until September 2016. Retrieved trials were evaluated using risk of bias. Primary outcome measures were the incidences of any recurrent adenomas and of advanced adenomas. Meta-analytic estimates were calculated with the random-effects model and random errors were evaluated with trial sequential analyses (TSAs). Five randomized trials (2234 patients with a history of adenomas) were included. Two of the 5 trials showed either unclear or high risks of bias in most criteria. Meta-analysis of good quality RCTs suggest a moderate protective effect of calcium supplementation on recurrence of adenomas (relative risk [RR], 0.88 [95% CI 0.79-0.99]); however, its effects on advanced adenomas did not show statistical significance (RR, 1.02 [95% CI 0.67-1.55]). Subgroup analyses demonstrated a greater protective effect on recurrence of adenomas with elemental calcium dose ≥1600 mg/day (RR, 0.74 [95% CI 0.56-0.97]) compared to ≤1200 mg/day (RR, 0.84 [95% CI 0.73-0.97]). No major serious adverse events were associated with the use of calcium, but there was an increase in the incidence of hypercalcemia (P = .0095). TSA indicated a lack of firm evidence for a beneficial effect. Concerns with directness and imprecision rated down the quality of the evidence to "low." The available good quality RCTs suggests a possible beneficial effect of calcium supplementation on the recurrence of adenomas; however, TSA indicated that the accumulated evidence is still inconclusive. Using GRADE-methodology, we conclude that the quality of evidence is low. Large well-designed randomized trials with low risk of bias are needed.

Justification de la prescription hors-AMM d’antibiotiques chez l’enfant hospitalisé

The aim of this study was to compare the level of evidence of UL/OL antibiotics prescription in hospitalized children. The initial hypothesis was that the UL/OL antibiotics prescriptions had a lower level of evidence than licensed antibiotics. This observational study assessed the antibiotics prescription in the children mother and women hospital of Lyon. Each antibiotic medicine courses was classified depending on: (i) they were licensed, UL or OL, (ii) their level of evidence for efficiency (sufficient evidence, insufficient evidence, no evidence) and (iii) the existence or not of randomized controlled trials (RCT) or not. The antibiotics medicine courses in atypical cases were excluded (rare disease, lack of diagnosis, comorbidities modifying antibiotic use). Data were collected with computerized patient file data. The data were compared using Fisher exact test and χ2. One hundred and eight medicine courses were identified, corresponding to 72mono, bi or tri-antibiotic therapies administered to 62 patients; 34% were OL and 66% were licensed. No prescriptions were UL. Thirty-two prescriptions were excluded from the evidence assessment. No proof of efficiency was found for any of the 76 analyzed medicine courses. RCTs were found for 36 of the analyzed medicine courses (47%); licensed medicine courses were significantly more justified by RCTs than UL/OL medicine courses (63% vs. 16%, P<0.001). This study has shown the absence of RCTs of good quality to justify the prescriptions of antibiotics in pediatrics, regardless their license status. Nevertheless, the licensed prescriptions have shown more data of efficiency than OL prescriptions. Still, even when data were found, no antibiotics prescriptions reach the threshold of good quality studies. New clinical trials should respond to the patient needs.

Economic Value of the Transurethral Resection in Saline System for Treatment of Benign Prostatic Hyperplasia in England and Wales: Systematic Review, Meta-analysis, and Cost–Consequence Model

ContextMonopolar transurethral resection of the prostate (M-TURP) is the current UK surgical standard of care for benign prostatic hyperplasia, a condition estimated to affect >2 million men in the United Kingdom. Although M-TURP efficacy in prostate resection is established, potential perioperative complications and associated costs remain a concern. ObjectiveTo present up-to-date and robust evidence in support of bipolar transurethral resection in saline (TURis) as an alternative surgical option to M-TURP. Evidence acquisitionA systematic review (SR) of electronic databases (up to 2015) for randomised controlled trials (RCTs) comparing TURis with M-TURP was conducted, followed by evidence synthesis in the form of a meta-analysis of hospital stay, catheterisation time and procedure duration, transurethral resection (TUR) syndrome, blood transfusion, clot retention, and urethral strictures. An economic analysis was subsequently undertaken from the UK National Health Service hospital perspective with costs and resource use data from published sources. Evidence synthesisThe SR identified 15 good-quality RCTs, of which 11 were used to inform the meta-analysis. TURis was associated with improved safety versus M-TURP, eliminating the risk of TUR syndrome and reducing the risk of blood transfusion and clot retention (relative risks: 0.34 and 0.43, respectively; p<0.05). TURis also reduced hospital stay (mean difference: 0.56 d; p<0.0001). The economic analysis indicated potential cost savings with TURis versus M-TURP of up to £204 per patient, with incremental equipment costs offset by savings from reduced hospital stay and fewer complications. ConclusionsThe TURis system is associated with significant improvements in perioperative safety compared with M-TURP while ensuring equivalent clinical outcomes of prostate resection. The safety benefits identified may translate into cost savings for UK health services. Patient summaryOur review of bipolar transurethral resection in saline, the new prostate resection technique, indicates that it offers equal efficacy while reducing complications and length of hospital stay.

Non-pharmacological interventions for reducing aggression and violence in serious mental illness: A systematic review and narrative synthesis

BackgroundFor people with mental illness that are violent, a range of interventions have been adopted with the aim of reducing violence outcomes. Many of these interventions have been borrowed from other (offender) populations and their evidence base in a Serious Mental Illness (SMI) population is uncertain. AimsTo aggregate the evidence base for non-pharmacological interventions in reducing violence amongst adults with SMI and PD (Personality Disorder), and to assess the efficacy of these interventions. We chose to focus on distinct interventions rather than on holistic service models where any element responsible for therapeutic change would be difficult to isolate. MethodsWe performed a systematic review and narrative synthesis of non-pharmacological interventions intended to reduce violence in a SMI population and in patients with a primary diagnosis of PD. Five online databases were searched alongside a manual search of seven relevant journals, and expert opinion was sourced. Eligibility of all returned articles was independently assessed by two authors, and quality of studies was appraised via the Cochrane Collaboration Tool for Assessing Risk of Bias. ResultsWe included 23 studies of diverse psychological and practical interventions, with a range of experimental and quasi-experimental study designs that included 7 Randomised Controlled Trials (RCTs). The majority were studies of Mentally Disordered Offenders. The stronger evidence existed for patients with a SMI diagnosis receiving Cognitive Behavioural Therapy or modified Reasoning & Rehabilitation (R&R). For patients with a primary diagnosis of PD, a modified version of R&R appeared tolerable and Enhanced Thinking Skills showed some promise in improving attitudes over the short-term, but studies of Dialectical Behaviour Therapy in this population were compromised by high risk of experimental bias. Little evidence could be found for non-pharmacological, non-psychological interventions. ConclusionsThe evidence for non-pharmacological interventions for reducing violence in this population is not conclusive. Long-term outcomes are lacking and good quality RCTs are required to develop a stronger evidence base.

Clinical effectiveness and cost-effectiveness of parenting interventions for children with severe attachment problems: a systematic review and meta-analysis.

Services have variable practices for identifying and providing interventions for 'severe attachment problems' (disorganised attachment patterns and attachment disorders). Several government reports have highlighted the need for better parenting interventions in at-risk groups. This report was commissioned to evaluate the clinical effectiveness and cost-effectiveness of parenting interventions for children with severe attachment problems (the main review). One supplementary review explored the evaluation of assessment tools and a second reviewed 10-year outcome data to better inform health economic aspects of the main review. A total of 29 electronic databases were searched with additional mechanisms for identifying a wide pool of references using the Cochrane methodology. Examples of databases searched include PsycINFO (1806 to January week 1, 2012), MEDLINE and MEDLINE In-Process & Other Non-Indexed Citations (1946 to December week 4, 2011) and EMBASE (1974 to week 1, 2012). Searches were carried out between 6 and 12 January 2012. Papers identified were screened and data were extracted by two independent reviewers, with disagreements arbitrated by a third independent reviewer. Quality assessment tools were used, including quality assessment of diagnostic accuracy studies - version 2 and the Cochrane risk of bias tool. Meta-analysis of randomised controlled trials (RCTs) of parenting interventions was undertaken. A health economics analysis was conducted. The initial search returned 10,167 citations. This yielded 29 RCTs in the main review of parenting interventions to improve attachment patterns, and one involving children with reactive attachment disorder. A meta-analysis of eight studies seeking to improve outcome in at-risk populations showed statistically significant improvement in disorganised attachment. The interventions saw less disorganised attachment at outcome than the control (odds ratio 0.47, 95% confidence interval 0.34 to 0.65; p < 0.00001). Much of this focused around interventions improving maternal sensitivity, with or without video feedback. In our first supplementary review, 35 papers evaluated an attachment assessment tool demonstrating validity or psychometric data. Only five reported test-retest data. Twenty-six studies reported inter-rater reliability, with 24 reporting a level of 0.7 or above. Cronbach's alphas were reported in 12 studies for the comparative tests (11 with α > 0.7) and four studies for the reference tests (four with α > 0.7). Three carried out concurrent validity comparing the Strange Situation Procedure (SSP) with another assessment tool. These had good sensitivity but poor specificity. The Disturbances of Attachment Interview had good sensitivity and specificity with the research diagnostic criteria (RDC) for attachment disorders. In our supplementary review of 10-year outcomes in cohorts using a baseline reference standard, two studies were found with disorganised attachment at baseline, with one finding raised psychopathology in adolescence. Budget impact analysis of costs was estimated because a decision model could not be justifiably populated. This, alongside other findings, informed research priorities. There are relatively few UK-based clinical trials. A 10-year follow-up, while necessary for our health economists for long-term sequelae, yielded a limited number of papers. Maternal sensitivity interventions show good outcomes in at-risk populations, but require further research with complex children. The SSP and RDC for attachment disorders remain the reference standards for identification until more concurrent and predictive validity research is conducted. A birth cohort with sequential attachment measures and outcomes across different domains is recommended with further, methodologically sound randomised controlled intervention trials. The main area identified for future work was a need for good-quality RCTs in at-risk groups such as those entering foster care or adoption. This study is registered as PROSPERO CRD42011001395. The National Institute for Health Research Health Technology Assessment programme.

The effectiveness of dopamine agonists for treatment of neuropsychiatric symptoms post brain injury and stroke.

Traumatic brain injury and stroke are among the leading causes of neurological disability worldwide. Although dopaminergic agents have long been associated with improvement of neuropsychiatric outcomes, to date much of the evidence to date has been in case reports and case series or open label trials. We undertook a systematic review of double-blinded randomised controlled trials (RCT) to determine the effect of dopaminergic agents on pre-defined outcomes of (a) apathy; (b) psychomotor retardation; (c) behavioural management and (d) cognitive function. Databases searched were: Medline, EMBASE, and PsychInfo for human studies. The Cochrane Clinical Trials Database and the TRIP Medical database were also searched. All identified studies, were further hand-searched. We identified six studies providing data on 227 participants, 150 of whom received dopaminergic therapy. Trials were compromised by cross-over design, inadequate wash out period, small numbers and heterogeneous outcome measures. However one good quality RCT demonstrates the efficacy of amantadine in behavioural management. One further RCT shows methylphenidate-levodopa is efficacious for mood post-stroke. One study shows rotigotine to improve hemi-inattention caused by prefrontal damage. Our systematic review demonstrates an evolving evidence base to suggest some benefits in agitation and aggression, mood and attentional deficits. However, there are key limitations of the studies undertaken to date involving small numbers of participants, heterogeneous outcome measures, and variable study designs. There is a need for on-going large prospective double-blind RCTs in these medications using standardised criteria and outcomes to fully understand their effectiveness in this patient group.

On framing the research question and choosing the appropriate research design.

Clinical epidemiology is the science of human disease investigation with a focus on diagnosis, prognosis, and treatment. The generation of a reasonable question requires definition of patients, interventions, controls, and outcomes. The goal of research design is to minimize error, to ensure adequate samples, to measure input and output variables appropriately, to consider external and internal validities, to limit bias, and to address clinical as well as statistical relevance. The hierarchy of evidence for clinical decision-making places randomized controlled trials (RCT) or systematic review of good quality RCTs at the top of the evidence pyramid. Prognostic and etiologic questions are best addressed with longitudinal cohort studies.