scholarly journals In-patient suicide: Selection of people at risk, failure of protection and the possibility of causation

BJPsych Open ◽  
2017 ◽  
Vol 3 (3) ◽  
pp. 102-105 ◽  
Author(s):  
Matthew Michael Large ◽  
Daniel Thomas Chung ◽  
Michael Davidson ◽  
Mark Weiser ◽  
Christopher James Ryan
Keyword(s):  
Large Scale ◽  
Social Role ◽  
Controlled Trial ◽  
Strong Association ◽  
Psychiatric Hospitals ◽  
Causal Role ◽  
Patient Suicide ◽  
Psychiatric Hospitalisation ◽  
Randomised Controlled ◽  
Selection Of

BackgroundBeing a current psychiatric in-patient is one of the strongest statistical risk factors for suicide. It is usually assumed that this strong association is not causal but is a result of the combination of the selection of high-risk patients for admission and the imperfect protection from suicide afforded by psychiatric wards. Logically, a third factor, which is causal, might play a role in the association. It has recently been suggested that adverse experiences in psychiatric units such as trauma, stigma and loss of social role might precipitate some in-patient suicides.AimsTo consider whether there is a causal association between psychiatric hospitalisation and suicide.MethodWe used the framework of Austin Bradford Hill's criteria for assessing causality in epidemiology to consider the possibility that psychiatric hospitalisation might causally contribute to the extent and variation in in-patient suicide rates.ResultsThe association between psychiatric hospitalisation and suicide clearly meets five of the nine Hill's criteria (strength of association, consistency, plausibility, coherence and analogy) and partially meets three of the remaining four criteria (gradient of exposure, temporality and experimental evidence).ConclusionsAdmission to hospital itself might play a causal role in a proportion of in-patient suicides. The safety of being in hospital with respect to suicide could be examined with a large-scale randomised controlled trial (RCT). In the absence of an RCT, the possibility of a causal role provides further impetus to calls to make care in the community more available and psychiatric hospitals more acceptable to patients.

scholarly journals Can we rely on non-randomised studies? Findings from a meta-epidemiological review

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
J C Rejon-Parrilla ◽  
M Salcher-Konrad ◽  
M Nguyen ◽  
K Davis ◽  
P Jonsson ◽  
...  
Keyword(s):  
Health Economic ◽  
Analytical Methods ◽  
Large Scale ◽  
Treatment Effects ◽  
Controlled Trial ◽  
Health Economic Evaluation ◽  
Risk Of Bias ◽  
Economic Decision Making ◽  
Wide Range ◽  
Randomised Controlled

Abstract Background Increasingly, health technology assessment (HTA) agencies must decide whether new medicines should be used routinely in the absence of randomised controlled trial (RCT) data, relying solely on non-randomised studies (NRS), which are at high risk of bias due to confounding. Against the background of increased availability and improved methods to analyse non-randomised data (e.g., propensity score methods and instrumental variables), it is important for decision-makers to have guidance on the analysis and interpretation of NRS to inform health economic evaluation. We therefore aimed to systematically and empirically assess the performance of NRS using different analytical methods as compared to RCTs and develop recommendations on the basis of our findings. Methods We conducted a large-scale meta-epidemiological review to obtain estimates of the discrepancy in treatment effects in matched RCTs and NRS of pharmacologic interventions from published meta-analyses indexed in MEDLINE and the Cochrane Database of Systematic Reviews. We also consulted with HTA bodies, regulators and academics from five European countries to learn from their experience with using non-randomised evidence. Results We compiled the largest dataset of clinical topics with matching RCTs and NRS using various analytical methods to date, covering >100 unique clinical questions. Incorporating information on direction of effect and effect size from >700 unique studies, the dataset can be used to evaluate discrepancies in treatment effects between study designs across a wide range of therapeutic areas. Conclusions An empirically based understanding of the risk of bias in NRS is required in order to promote the adequate use of non-randomised evidence as input for health economic decision-making.

scholarly journals Effects of a workplace prevention programme for problem gambling: study protocol for a cluster randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e015963 ◽  
Author(s):  
Jonas Rafi ◽  
Ekaterina Ivanova ◽  
Alexander Rozental ◽  
Per Carlbring
Keyword(s):  
Problem Gambling ◽  
Large Scale ◽  
Controlled Trial ◽  
Public Health Problem ◽  
Cluster Randomised Controlled Trial ◽  
Severity Index ◽  
The Body ◽  
Prevention Programme ◽  
Open Access Journals ◽  
Randomised Controlled

IntroductionDespite being considered a public health problem, no prevention programme for problem gambling in workplace settings has been scientifically evaluated. This study aims to fill a critical gap in the field of problem gambling by implementing and evaluating a large-scale prevention programme in organisations.Methods and analysisTen organisations, with a total of n=549 managers and n=8572 employees, will be randomised to either receiving a prevention programme or to a waitlist control condition. Measurements will be collected at the baseline and 3, 12 and 24 months after intervention. The primary outcome of interest is the managers’ inclination to act when worried or suspicious about an employee’s problem gambling or other harmful use. Additional outcomes of interest include the Problem Gambling Severity Index and gambling habits in both managers and employees. Furthermore, qualitative analyses of the responses from semistructured interviews with managers will be performed.Ethics and disseminationThis study has been approved by the regional ethics board of Stockholm, Sweden, and it will contribute to the body of knowledge concerning prevention of problem gambling. The findings will be published in peer-reviewed, open-access journals.Trial registration numberNCT02925286; Pre-results.

scholarly journals Nordic Innovative Trials to Evaluate osteoPorotic Fractures (NITEP) Collaboration: The Nordic DeltaCon Trial protocol—non-operative treatment versus reversed total shoulder arthroplasty in patients 65 years of age and older with a displaced proximal humerus fracture: a prospective, randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024916 ◽  
Author(s):  
Antti P Launonen ◽  
Tore Fjalestad ◽  
Minna K Laitinen ◽  
Tuomas Lähdeoja ◽  
Carl Ekholm ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Operative Treatment ◽  
Shoulder Arthroplasty ◽  
Large Scale ◽  
Proximal Humerus Fracture ◽  
Proximal Humerus ◽  
Controlled Trial ◽  
Total Shoulder Arthroplasty ◽  
Humerus Fracture ◽  
Randomised Controlled

IntroductionThe proximal humerus fracture (PHF) is one of the most common fractures in the elderly. The majority of PHFs are treated non-operatively, while 15%–33% of patients undergo surgical treatment. Recent randomised controlled trial (RCT) and meta-analyses have shown that there is no difference in outcome between non-operative treatment and locking plate or hemi-arthroplasty. During the past decade, reverse total shoulder arthroplasty (RTSA) has gained popularity in the treatment of PHF, although there is a lack of RCTs comparing RTSA to non-operative treatment.MethodsThis is a prospective, single-blinded, randomised, controlled, multicentre and multinational trial comparing RTSA with non-operative treatment in displaced proximal humeral fractures in patients 65–85 years. The primary outcome in this study is QuickDASH-score measured at 2 years. Secondary outcomes include visual analogue scale for pain, grip strength, Oxford shoulder score, Constant score and the number of reoperations and complications.The hypothesis of the trial is that operative treatment with RTSA produces better outcome after 2 and 5 years measured with QuickDASH.Ethics and disseminationIn this protocol, we describe the design, method and management of the Nordic DeltaCon trial. The ethical approval for the trial has been given by the Regional Committee for Medical and Health Research Ethics, Norway. There have been several examples in orthopaedics of innovations that result in failure after medium-term follow-ups . In order to prevent such failures and to increase our knowledge of RSTA, we feel a large-scale study of the effects of the surgery on the outcome that focuses on the complications and reoperations is warranted. After the trial 2-year follow-up, the results will be disseminated in a major orthopaedic publication.Trial registration numberNCT03531463; Pre-Results.

scholarly journals Strategies to promote healthier food purchases: a pilot supermarket intervention study

2007 ◽  
Vol 10 (6) ◽  
pp. 608-615 ◽  
Author(s):  
Cliona Ni Mhurchu ◽  
Tony Blakely ◽  
Joanne Wall ◽  
Anthony Rodgers ◽  
Yannan Jiang ◽  
...  
Keyword(s):  
Nutrition Education ◽  
Low Income ◽  
Large Scale ◽  
Controlled Trial ◽  
Main Trial ◽  
Electronic Data Collection ◽  
Price Discounts ◽  
Food Purchases ◽  
Pilot Rct ◽  
Randomised Controlled

AbstractObjectiveTo pilot the design and methodology for a large randomised controlled trial (RCT) of two interventions to promote healthier food purchasing: culturally appropriate nutrition education and price discounts.DesignA 12-week, single-blind, pilot RCT. Effects on food purchases were measured using individualised electronic shopping data (‘Shop ’N Go’ system). Partial data were also collected on food expenditure at other (non-supermarket) retail outlets.SettingA supermarket in Wellington, New Zealand.ParticipantsEligible customers were those who were the main household shoppers, shopped mainly at the participating store, and were registered to use the Shop ’N Go system. Ninety-seven supermarket customers (72% women; age 40 ± 9.6 years, mean ± standard deviation) were randomised to one of four intervention groups: price discounts, nutrition education, a combination of price discounts and nutrition education, or control (no intervention).ResultsThere was a 98% follow-up rate of participants, with 85% of all reported supermarket purchases being captured via the electronic data collection system. The pilot did, however, demonstrate difficulty recruiting Maori, Pacific and low-income shoppers using the electronic register and mail-out.ConclusionsThis pilot study showed that electronic sales data capture is a viable way to measure effects of study interventions on food purchases in supermarkets, and points to the feasibility of conducting a large-scale RCT to evaluate the effectiveness of price discounts and nutrition education. Recruitment strategies will, however, need to be modified for the main trial in order to ensure inclusion of all ethnic and socio-economic groups.

scholarly journals One year later: Highlighting the challenges and opportunities in disseminating a breathing-retraining digital behaviour change intervention

2020 ◽  
Vol 6 ◽  
pp. 205520762093644
Author(s):  
Ben Ainsworth ◽  
Anne Bruton ◽  
Mike Thomas ◽  
Lucy Yardley
Keyword(s):  
Behaviour Change ◽  
Large Scale ◽  
Digital Health ◽  
Low Cost ◽  
Controlled Trial ◽  
Cost Effective ◽  
Challenges And Opportunities ◽  
Breathing Retraining ◽  
One Year ◽  
Randomised Controlled

Digital behaviour change interventions can provide effective and cost-effective treatments for a range of health conditions. However, after rigorous evaluation, there still remain challenges to disseminating and implementing evidence-based interventions that can hinder their effectiveness ‘in the real world’. We conducted a large-scale randomised controlled trial of self-guided breathing retraining, which we then disseminated freely as a digital intervention. Here we share our experience of this process after one year, highlighting the opportunities that digital health interventions can offer alongside the challenges that must be addressed in order to harness their effectiveness. Whilst such treatments can support many individuals at extremely low cost, careful dissemination strategies should be proactively planned in order to ensure such opportunities are maximised and interventions remain up to date in a fast-moving digital landscape.

scholarly journals Safety and efficacy of 2% chlorhexidine gluconate aqueous versus 2% chlorhexidine gluconate in 70% isopropyl alcohol for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: the ARCTIC randomised-controlled feasibility trial protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e028022 ◽  
Author(s):  
Paul Clarke ◽  
Jean V Craig ◽  
John Wain ◽  
Catherine Tremlett ◽  
Louise Linsell ◽  
...  
Keyword(s):  
Large Scale ◽  
Controlled Trial ◽  
Venous Catheter ◽  
Chlorhexidine Gluconate ◽  
Feasibility Trial ◽  
Preterm Neonates ◽  
Central Venous ◽  
Skin Disinfection ◽  
Randomised Controlled ◽  
Catheter Colonisation

IntroductionCatheter-related sepsis is one of the most dangerous complications of neonatal intensive care and is associated with significant morbidity and mortality. Use of catheter-care ‘bundles’ has reduced the incidence of catheter-related sepsis, although individual components have not been well studied. Better evidence is needed to guide selection of the most appropriate antiseptic solution for skin disinfection in preterm neonates. This study will inform the feasibility and design of the first randomised controlled trial to examine the safety and efficacy of alcohol-based versus aqueous-based chlorhexidine antiseptic formulations for skin disinfection prior to percutaneous central venous catheterisation in preterm neonates. The antiseptics to be compared are 2% chlorhexidine gluconate (CHG) aqueous and 2% CHG in 70% isopropyl alcohol.Methods and analysisThe Antiseptic Randomised Controlled Trial for Insertion of Catheters (ARCTIC) is a two-centre randomised-controlled feasibility trial. At least 100 preterm infants born at <34 weeks’ gestation and due to undergo percutaneous insertion of a central venous catheter will be randomly allocated to receive prior skin disinfection with one of the two antiseptic solutions. Outcomes include: i) recruitment and retention rates; ii) completeness of data collection; iii) numbers of enrolled infants meeting case definitions for definite catheter-related sepsis, catheter-associated sepsis and catheter colonisation and iv) safety outcomes of skin morbidity scores recorded daily from catheter insertion until 48 hours post removal. The key feasibility metrics will be reported as proportions with 95% CIs. Estimated prevalence of catheter colonisation will allow calculation of sample size for the large-scale trial. The data will inform whether it will be feasible to progress to a large-scale trial.Ethics and disseminationARCTIC has been approved by the National Health Service Health Research Authority National Research Ethics Service Committee East of England (Cambridge South) (IRAS ID 163868), was adopted onto the National Institute of Health Research Clinical Research Network portfolio (CPMS ID 19899) and is registered with an International Standard Randomised Control Trials Number (ISRCTN: 82571474; Pre-results) and European Clinical Trials Database number 2015-000874-36. Dissemination plans include presentations at scientific conferences, scientific publications and sharing of the findings with parents via the support of Bliss baby charity.Trial registration numberISRCTN82571474; Pre-results.

scholarly journals Persistent sub-microscopic Plasmodium falciparum parasitaemia 72 hours after treatment with artemether-lumefantrine predicts 42-day treatment failure in Mali and Burkina Faso

2021 ◽  
Author(s):  
Khalid B Beshir ◽  
Nouhoum Diallo ◽  
Fabrice A Somé ◽  
Salif Sombie ◽  
Issaka Zongo ◽  
...  
Keyword(s):  
Plasmodium Falciparum ◽  
West Africa ◽  
Burkina Faso ◽  
Large Scale ◽  
Day Treatment ◽  
Controlled Trial ◽  
Parasite Clearance ◽  
Time Interval ◽  
Clinical Episode ◽  
Randomised Controlled

A recent randomised controlled trial, WANECAM, conducted at seven centres in West Africa, found that artemether-lumefantrine, artesunate-amodiaquine, pyronaridine-artesunate and dihydroartemisinin-piperaquine all displayed good efficacy. However, artemether-lumefantrine was associated with a shorter interval between clinical episodes than the other regimens. In a further comparison of these therapies, we identified cases of persisting sub-microscopic parasitaemia by qPCR at 72h post-treatment among WANECAM participants from 5 sites in Mali and Burkina Faso, and compared treatment outcomes for this group to those with complete parasite clearance by 72h. Among 547 evaluable patients, 17.7% had qPCR-detectable parasitaemia at 72h during their first treatment episode. This proportion varied among sites, reflecting differences in malaria transmission intensity, but did not differ among pooled drug treatment groups. However, patients who received artemether-lumefantrine and were qPCR positive at 72h were significantly more likely to have microscopically-detectable recurrent Plasmodium falciparum parasitaemia by day 42 than those receiving other regimens, and experienced on average a shorter time-interval before the next clinical episode. Haplotypes of pfcrt and pfmdr1 were also evaluated in persisting parasites. These data identify a possible threat to the parasitological efficacy of artemether-lumefantrine in West Africa, over a decade since it was first introduced on a large scale.

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