Thoracoscopy and talc poudrage compared with intercostal drainage and talc slurry infusion to manage malignant pleural effusion: the TAPPS RCT

Background There are around 40,000 new cases of malignant pleural effusion in the UK each year. Insertion of talc slurry via a chest tube is the current standard treatment in the UK. However, some centres prefer local anaesthetic thoracoscopy and talc poudrage. There is no consensus as to which approach is most effective. Objective This trial tested the hypothesis that thoracoscopy and talc poudrage increases the proportion of patients with successful pleurodesis at 3 months post procedure, compared with chest drain insertion and talc slurry. Design This was a multicentre, open-label, randomised controlled trial with embedded economic evaluation. Follow-up took place at 1, 3 and 6 months. Setting This trial was set in 17 NHS hospitals in the UK. Participants A total of 330 adults with a confirmed diagnosis of malignant pleural effusion needing pleurodesis and fit to undergo thoracoscopy under local anaesthetic were included. Those adults needing a tissue diagnosis or with evidence of lung entrapment were excluded. Interventions Allocation took place following minimisation with a random component, performed by a web-based, centralised computer system. Participants in the control arm were treated with a bedside chest drain insertion and 4 g of talc slurry. In the intervention arm, participants underwent local anaesthetic thoracoscopy with 4 g of talc poudrage. Main outcome measures The primary outcome measure was pleurodesis failure at 90 days post randomisation. Secondary outcome measures included mortality and patient-reported symptoms. A cost–utility analysis was also performed. Results A total of 166 and 164 patients were allocated to poudrage and slurry, respectively. Participants were well matched at baseline. For the primary outcome, no significant difference in pleurodesis failure was observed between the treatment groups at 90 days, with rates of 36 out of 161 (22%) and 38 out of 159 (24%) noted in the poudrage and slurry groups, respectively (odds ratio 0.91, 95% confidence interval 0.54 to 1.55; p = 0.74). No differences (or trends towards difference) were noted in adverse events or any of the secondary outcomes at any time point, including pleurodesis failure at 180 days [poudrage 46/161 (29%), slurry 44/159 (28%), odds ratio 1.05, 95% confidence interval 0.63 to 1.73; p = 0.86], mean number of nights in hospital over 90 days [poudrage 12 nights (standard deviation 13 nights), slurry 11 nights (standard deviation 10 nights); p = 0.35] and all-cause mortality at 180 days [poudrage 66/166 (40%), slurry 68/164 (42%); p = 0.70]. At £20,000 per quality-adjusted life-year gained, poudrage would have a 0.36 probability of being cost-effective compared with slurry. Limitations Entry criteria specified that patients must be sufficiently fit to undergo thoracoscopy, which may make the results less applicable to those patients presenting with a greater degree of frailty. Furthermore, the trial was conducted on an open-label basis, which may have influenced the results of patient-reported measures. Conclusions The TAPPS (evaluating the efficacy of Thoracoscopy And talc Poudrage versus Pleurodesis using talc Slurry) trial has robustly demonstrated that there is no additional clinical effectiveness or cost-effectiveness benefit in performing talc poudrage at thoracoscopy over bedside chest drain and talc slurry for the management of malignant pleural effusion. Trial registration Current Controlled Trials ISRCTN47845793. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 26. See the NIHR Journals Library website for further project information.

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Prognostic factors associated to survival in patients with malignant pleural effusion (MPE) undergoing talc poudrage pleurodesis (TPP)

10.1183/13993003.congress-2016.pa3389 ◽

2016 ◽

Author(s):

Rocio Magdalena Diaz Campos ◽

Maria Victoria Villena Garrido ◽

Enrique Cases Viedma ◽

Jose Manuel Porcel Perez ◽

Inmaculada Alfageme Michavila ◽

...

Keyword(s):

Prognostic Factors ◽

Pleural Effusion ◽

Malignant Pleural Effusion ◽

Factors Associated ◽

Talc Poudrage

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Talc poudrage versus talc slurry in the treatment of malignant pleural effusion.

European Journal of Cardio-Thoracic Surgery ◽

10.1016/j.ejcts.2006.10.002 ◽

2006 ◽

Vol 30 (6) ◽

pp. 827-832 ◽

Cited By ~ 84

Author(s):

Alessandro Stefani ◽

Pamela Natali ◽

Christian Casali ◽

Uliano Morandi

Keyword(s):

Pleural Effusion ◽

Malignant Pleural Effusion ◽

Talc Poudrage

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Intravenous co-amoxiclav to prevent infection after operative vaginal delivery: the ANODE RCT

Health Technology Assessment ◽

10.3310/hta23540 ◽

2019 ◽

Vol 23 (54) ◽

pp. 1-54

Author(s):

Marian Knight ◽

Virginia Chiocchia ◽

Christopher Partlett ◽

Oliver Rivero-Arias ◽

Xinyang Hua ◽

...

Keyword(s):

Single Dose ◽

Primary Outcome ◽

Controlled Trial ◽

Prophylactic Antibiotic ◽

Health Technology ◽

Prophylactic Antibiotics ◽

Vaginal Birth ◽

Suspected Infection ◽

The Uk ◽

Care Costs

Background Sepsis is a leading cause of direct and indirect maternal death in both the UK and globally. All forms of operative delivery are associated with an increased risk of sepsis, and the National Institute for Health and Care Excellence’s guidance recommends the use of prophylactic antibiotics at all caesarean deliveries, based on substantial randomised controlled trial evidence of clinical effectiveness. A Cochrane review, updated in 2017 (Liabsuetrakul T, Choobun T, Peeyananjarassri K, Islam QM. Antibiotic prophylaxis for operative vaginal delivery. Cochrane Database Syst Rev 2017;8:CD004455), identified only one small previous trial of prophylactic antibiotics following operative vaginal birth (forceps or ventouse/vacuum extraction) and, given the small study size and extreme result, suggested that further robust evidence is needed. Objectives To investigate whether or not a single dose of prophylactic antibiotic following operative vaginal birth is clinically effective for preventing confirmed or presumed maternal infection, and to investigate the associated impact on health-care costs. Design A multicentre, randomised, blinded, placebo-controlled trial. Setting Twenty-seven maternity units in the UK. Participants Women who had an operative vaginal birth at ≥ 36 weeks’ gestation, who were not known to be allergic to penicillin or constituents of co-amoxiclav and who had no indication for ongoing antibiotics. Interventions A single dose of intravenous co-amoxiclav (1 g of amoxicillin/200 mg of clavulanic acid) or placebo (sterile saline) allocated through sealed, sequentially numbered, indistinguishable packs. Main outcome measures Primary outcome – confirmed or suspected infection within 6 weeks of giving birth. Secondary outcomes – severe sepsis, perineal wound infection, perineal pain, use of pain relief, hospital bed stay, hospital/general practitioner visits, need for additional perineal care, dyspareunia, ability to sit comfortably to feed the baby, maternal general health, breastfeeding, wound breakdown, occurrence of anaphylaxis and health-care costs. Results Between March 2016 and June 2018, 3427 women were randomised: 1719 to the antibiotic arm and 1708 to the placebo arm. Seven women withdrew, leaving 1715 women in the antibiotic arm and 1705 in the placebo arm for analysis. Primary outcome data were available for 3225 out of 3420 women (94.3%). Women randomised to the antibiotic arm were significantly less likely to have confirmed or suspected infection within 6 weeks of giving birth (180/1619, 11%) than women randomised to the placebo arm (306/1606, 19%) (relative risk 0.58, 95% confidence interval 0.49 to 0.69). Three serious adverse events were reported: one in the placebo arm and two in the antibiotic arm (one was thought to be causally related to the intervention). Limitations The follow-up rate achieved for most secondary outcomes was 76%. Conclusions This trial has shown clear evidence of benefit of a single intravenous dose of prophylactic co-amoxiclav after operative vaginal birth. These results may lead to reconsideration of official policy/guidance. Further analysis of the mechanism of action of this single dose of antibiotic is needed to investigate whether earlier, pre-delivery or repeated administration could be more effective. Until these analyses are completed, there is no indication for administration of more than a single dose of prophylactic antibiotic, or for pre-delivery administration. Trial registration Current Controlled Trials ISRCTN11166984. Funding This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 54. See the National Institute for Health Research Journals Library website for further project information.

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Suitable device for thoracoscopic talc poudrage in malignant pleural effusion

General Thoracic and Cardiovascular Surgery ◽

10.1007/s11748-010-0746-0 ◽

2011 ◽

Vol 59 (7) ◽

pp. 522-524

Author(s):

Andrea Billè ◽

Piero Borasio ◽

Mara Gisabella ◽

Luca Errico ◽

Robert Gatherer ◽

...

Keyword(s):

Pleural Effusion ◽

Malignant Pleural Effusion ◽

Talc Poudrage

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Adding emollient bath additives to standard eczema management for children with eczema: the BATHE RCT

Health Technology Assessment ◽

10.3310/hta22570 ◽

2018 ◽

Vol 22 (57) ◽

pp. 1-116 ◽

Cited By ~ 3

Author(s):

Miriam Santer ◽

Kate Rumsby ◽

Matthew J Ridd ◽

Nick A Francis ◽

Beth Stuart ◽

...

Keyword(s):

Health Technology Assessment ◽

Technology Assessment ◽

Primary Outcome ◽

Intervention Group ◽

Additive Group ◽

Health Technology ◽

Control Group ◽

Open Label ◽

Secondary Outcomes ◽

Bath Additives

BackgroundChildhood eczema is very common. Treatment often includes emollient bath additives, despite there being little evidence of their effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of emollient bath additives in the management of childhood eczema.DesignPragmatic, randomised, open-label, multicentre superiority trial with two parallel groups.SettingNinety-six general practices in Wales, the west of England and southern England. Invitation by personal letter or opportunistically.ParticipantsChildren aged between 12 months and 12 years fulfilling the UK Diagnostic Criteria for Atopic Eczema. Children with inactive or very mild eczema (a score of ≤ 5 on the Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once per week or whose parents/carers were not prepared to accept randomisation.InterventionsThe intervention group were prescribed bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued standard eczema management, including regular leave-on emollients and topical corticosteroids (TCSs) when required.Main outcome measuresThe primary outcome was eczema control measured by Patient Oriented Eczema Measure [POEM, 0 (clear) to 28 (severe)] weekly for 16 weeks. The secondary outcomes were eczema severity over 1 year (4-weekly POEM), number of eczema exacerbations, disease-specific quality of life (QoL) (Dermatitis Family Impact Questionnaire), generic QoL (Child Health Utility-9 Dimensions) and type and quantity of topical steroid/calcineurin inhibitors prescribed. Children were randomised (1 : 1) using online software to either bath additives plus standard eczema care or standard eczema care alone, stratified by recruiting centre, and there was open-label blinding.ResultsFrom December 2014 to May 2016, 482 children were randomised: 51% were female, 84% were white and the mean age was 5 years (n = 264 in the intervention group,n = 218 in the control group). Reported adherence to randomised treatment allocation was > 92% in both groups, with 76.7% of participants completing at least 12 (80%) of the first 16 weekly questionnaires for the primary outcome. Baseline POEM score was 9.5 [standard deviation (SD) 5.7] in the bath additives group and 10.1 (SD 5.8) in the no bath additives group. Average POEM score over the first 16 weeks was 7.5 (SD 6.0) in the bath additives group and 8.4 (SD 6.0) in the no bath additives group, with no statistically significant difference between the groups. After controlling for baseline severity and confounders (ethnicity, TCS use, soap substitute use) and allowing for clustering of participants within centres and responses within participants over time, POEM scores in the no bath additive group were 0.41 points higher than in the bath additive group (95% confidence interval –0.27 to 1.10), which is well below the published minimal clinically important difference of 3 points. There was no difference between groups in secondary outcomes or in adverse effects such as redness, stinging or slipping.LimitationsSimple randomisation resulted in an imbalance in baseline group size, although baseline characteristics were well balanced between groups.ConclusionThis trial found no evidence of clinical benefit of including emollient bath additives in the standard management of childhood eczema.Future workFurther research is required on optimal regimens of leave-on emollients and the use of emollients as soap substitutes.Trial registrationCurrent Controlled Trials ISRCTN84102309.FundingThis project was funded by the NIHR Health Technology Assessment Programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 57. See the NIHR Journals Library website for further project information.

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Phase III Intergroup Study of Talc Poudrage vs Talc Slurry Sclerosis for Malignant Pleural Effusion

CHEST Journal ◽

10.1378/chest.127.3.909 ◽

2005 ◽

Vol 127 (3) ◽

pp. 909-915 ◽

Cited By ~ 330

Author(s):

Carolyn M Dresler ◽

Jemi Olak ◽

James E Herndon ◽

William G Richards ◽

Ernest Scalzetti ◽

...

Keyword(s):

Pleural Effusion ◽

Malignant Pleural Effusion ◽

Phase Iii ◽

Talc Poudrage

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Talc poudrage for malignant pleural effusion

Journal of Thoracic and Cardiovascular Surgery ◽

10.1016/s0022-5223(19)43303-5 ◽

1966 ◽

Vol 51 (5) ◽

pp. 732-738 ◽

Cited By ~ 37

Author(s):

F.G. Pearson ◽

D.C. MacGregor

Keyword(s):

Pleural Effusion ◽

Malignant Pleural Effusion ◽

Talc Poudrage

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International open-label studies to assess the efficacy and safety of single-pill amlodipine/atorvastatin in attaining blood pressure and lipid targets recommended by country-specific guidelines: the JEWEL programme

European Journal of Cardiovascular Prevention & Rehabilitation ◽

10.1097/hjr.0b013e32832b63f5 ◽

2009 ◽

Vol 16 (4) ◽

pp. 472-480 ◽

Cited By ~ 9

Author(s):

Frederick D. Richard Hobbs ◽

Gianfranco Gensini ◽

Giovanni B. John Mancini ◽

Athanasios J. Manolis ◽

Beverly Bauer ◽

...

Keyword(s):

Blood Pressure ◽

Primary Outcome ◽

Lifestyle Modification ◽

Low Density Lipoprotein ◽

Density Lipoprotein ◽

Open Label ◽

The United Kingdom ◽

Single Pill ◽

The Uk ◽

Country Specific

Background Single-pill amlodipine/atorvastatin targets the two most common modifiable cardiovascular risk factors, hypertension and dyslipidaemia. We evaluated the clinical utility of this single pill to help patients across Europe and Canada achieve country-specific targets for blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C). Design Two 16-week, open-label studies conducted in 122 study centres across the United Kingdom and Canada (JEWEL 1) and 113 centres across 11 European countries (JEWEL 2). Methods Patients with uncontrolled BP and controlled/uncontrolled LDL-C qualifying for treatment according to local governing guidelines were administered single-pill amlodipine/atorvastatin with appropriate lifestyle modification. Eight dosages of amlodipine/atorvastatin (5/10–10/80 mg) were titrated to achieve country-specific BP and LDL-C targets. The primary outcome was the percentage of patients reaching country-specific BP and LDL-C targets in 16 weeks. Results Among 2245 patients enrolled in the studies (JEWEL 1, n = 1138; JEWEL 2, n = 1107), 62.9% in JEWEL 1 and 50.6% in JEWEL 2 achieved both country-specific BP and LDL-C goals. BP was reduced by 20.4/10.7 and 21.8/12.6 mmHg in JEWEL 1 and JEWEL 2, respectively, and reductions in LDL-C were 0.90 mmol/l (34.8 mg/dl) and 1.09 mmol/l (42.2 mg/dl), respectively. The most common adverse events were peripheral oedema (11.0%), joint swelling (2.9%) and headache (2.9%), of which, only oedema was linked to study treatment. Conclusion Single-pill amlodipine/atorvastatin is an effective and well-tolerated treatment, which in a real-world setting helped more than half of the patients achieve both BP and LDL-C targets as recommended by local guidelines. Although fewer patients met their goals in JEWEL 2 than JEWEL 1, reductions in BP and LDL-C were slightly greater in JEWEL 2, suggesting that the observed differences are likely because of more stringent targets in Europe than in the UK/Canada.

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Female Urgency, Trial of Urodynamics as Routine Evaluation (FUTURE study): a superiority randomised clinical trial to evaluate the effectiveness and cost-effectiveness of invasive urodynamic investigations in management of women with refractory overactive bladder symptoms

Trials ◽

10.1186/s13063-021-05661-3 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

M. Abdel-fattah ◽

C. Chapple ◽

K. Guerrero ◽

S. Dixon ◽

N. Cotterill ◽

...

Keyword(s):

Cost Effectiveness ◽

Overactive Bladder ◽

Clinical Assessment ◽

Future Study ◽

Primary Outcome ◽

Cost Effective ◽

Female Population ◽

Patient Reported ◽

The Uk ◽

Post Randomisation

Abstract Background Overactive bladder (OAB) syndrome is a symptom complex affecting 12–14% of the UK adult female population. Symptoms include urinary urgency, with or without urgency incontinence, increased daytime urinary frequency and nocturia. OAB has a negative impact on women’s social, physical, and psychological wellbeing. Initial treatment includes lifestyle modifications, bladder retraining, pelvic floor exercises and pharmacological therapy. However, these measures are unsuccessful in 25–40% of women (refractory OAB). Before considering invasive treatments, such as Botulinum toxin injection or sacral neuromodulation, most guidelines recommend urodynamics to confirm diagnosis of detrusor overactivity (DO). However, urodynamics may fail to show evidence of DO in up to 45% of cases, hence the need to evaluate its effectiveness and cost-effectiveness. FUTURE (Female Urgency, Trial of Urodynamics as Routine Evaluation) aims to test the hypothesis that, in women with refractory OAB, urodynamics and comprehensive clinical assessment is associated with superior patient-reported outcomes following treatment and is more cost-effective, compared to comprehensive clinical assessment only. Methods FUTURE is a pragmatic, multi-centre, superiority randomised controlled trial. Women aged ≥ 18 years with refractory OAB or urgency predominant mixed urinary incontinence, and who have failed/not tolerated conservative and medical treatment, are considered for trial entry. We aim to recruit 1096 women from approximately 60 secondary/tertiary care hospitals across the UK. All consenting women will complete questionnaires at baseline, 3 months, 6 months and 15 months post-randomisation. The primary outcome is participant-reported success at 15 months post-randomisation measured using the Patient Global Impression of Improvement. The primary economic outcome is incremental cost per quality-adjusted life year gained at 15 months. The secondary outcomes include adverse events, impact on other urinary symptoms and health-related quality of life. Qualitative interviews with participants and clinicians and a health economic evaluation will also be conducted. The statistical analysis of the primary outcome will be by intention-to-treat. Results will be presented as estimates and 95% CIs. Discussion The FUTURE study will inform patients, clinicians and policy makers whether routine urodynamics improves treatment outcomes in women with refractory OAB and whether it is cost-effective. Trial registration ISRCTN63268739. Registered on 14 September 2017.

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