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

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.

scholarly journals Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial

2017 ◽  
Vol 21 (34) ◽  
pp. 1-92 ◽  
Author(s):  
William Jeffcoate ◽  
Frances Game ◽  
Vivienne Turtle-Savage ◽  
Alison Musgrove ◽  
Patricia Price ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Usual Care ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Health Technology ◽  
Control Group ◽  
Advisory Panel ◽  
Health Economic Analysis ◽  
Randomised Controlled

Background Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel. Objective To assess both the clinical effectiveness and the cost-effectiveness of lightweight fibreglass casts in the management of heel ulcers. Design A pragmatic, multicentre, parallel, observer-blinded randomised controlled trial. A central randomisation centre used a computer-generated random number sequence to allocate participants to groups. Setting Thirty-five specialist diabetic foot secondary care centres in the UK. Those recruited were aged ≥ 18 years and had diabetes mellitus complicated by ulcers of the heel of grades 2–4 on the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel scale. Participants In total, 509 participants [68% male, 15% with type 1 diabetes mellitus, mean age 67.5 years (standard deviation 12.4 years)] were randomised 1 : 1 to the intervention (n = 256) or the control (n = 253) arm. The primary outcome data were available for 425 participants (212 from the intervention arm and 213 from the control arm) and exceeded the total required; attrition was 16.5%. The median ulcer area at baseline was 275 mm2 [interquartile range (IQR) 104–683 mm2] in the intervention group and 206 mm2 (IQR 77–649 mm2) in the control group. There were no differences between the two groups at baseline in any parameter, neither in relation to the participant nor in relation to their ulcer. Interventions The intervention group received usual care supplemented by the addition of an individually moulded, lightweight, fibreglass heel cast. The control group received usual care alone. The intervention phase continued either until the participant’s ulcer had healed (maintained for 28 days) or for 24 weeks, whichever occurred first. During this intervention phase, the participants were reviewed every 2 weeks, and the fibreglass casts were replaced when they were no longer usable. Main outcome measures The primary outcome measure was ulcer healing (confirmed by a blinded observer and maintained for 4 weeks) within 24 weeks. Other outcome measures included the time taken for the ulcer to heal, the percentage reduction in the cross-sectional area, the reduction in local pain, amputation, survival and health economic analysis. The study was powered to define a difference in healing of 15% (55% intervention vs. 40% control). Results Forty-four per cent (n = 94) of the intervention group healed within 24 weeks, compared with 37% (n = 80) of the control participants (odds ratio 1.42, 95% confidence interval 0.95 to 2.14; p = 0.088), using an intention-to-treat analysis. No differences were observed between the two groups for any secondary outcome. Limitations Although the component items of care were standardised, because this was a pragmatic trial, usual care was not uniform. There was some evidence of a small excess of adverse events in the intervention group; however, non-blinded observers documented these events. There was no excess of adverse device effects. Conclusions There may be a small increase in healing with the use of a heel cast, but the estimate was not sufficiently precise to provide strong evidence of an effect. There was no evidence of any subgroup in which the intervention appeared to be particularly effective. A health economic analysis suggested that it is unlikely that the intervention represents good value for money. The provision of a lightweight heel cast may be of benefit to some individuals, but we have found no evidence to justify the routine adoption of this in clinical practice. Future work It is unlikely that further study of this intervention will have an impact on usual clinical care, and so future efforts should be directed towards other interventions designed to improve the healing of ulcers in this population. Trial registration Current Controlled Trials ISRCTN62524796. 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. 21, No. 34. See the NIHR Journals Library website for further project information.

scholarly journals The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial – a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults

2015 ◽  
Vol 19 (24) ◽  
pp. 1-280 ◽  
Author(s):  
Helen Handoll ◽  
Stephen Brealey ◽  
Amar Rangan ◽  
Ada Keding ◽  
Belen Corbacho ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Proximal Humerus ◽  
Surgical Intervention ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Randomised Controlled ◽  
The Uk ◽  
The Cost ◽  
Non Surgical Treatment

BackgroundProximal humeral fractures account for 5–6% of all fractures in adults. There is considerable variation in whether or not surgery is used in the management of displaced fractures involving the surgical neck.ObjectiveTo evaluate the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment of the majority of displaced fractures of the proximal humerus involving the surgical neck in adults.DesignA pragmatic parallel-group multicentre randomised controlled trial with an economic evaluation. Follow-up was for 2 years.SettingRecruitment was undertaken in the orthopaedic departments of 33 acute NHS hospitals in the UK. Patient care pathways included outpatient and community-based rehabilitation.ParticipantsAdults (aged ≥ 16 years) presenting within 3 weeks of their injury with a displaced fracture of the proximal humerus involving the surgical neck.InterventionsThe choice of surgical intervention was left to the treating surgeons, who used techniques with which they were experienced. Non-surgical treatment was initial sling immobilisation followed by active rehabilitation. Provision of rehabilitation was comparable in both groups.Main outcome measuresThe primary outcome was the Oxford Shoulder Score (OSS) assessed at 6, 12 and 24 months. Secondary outcomes were the 12-item Short Form health survey, surgical and other shoulder fracture-related complications, secondary surgery to the shoulder or increased/new shoulder-related therapy, medical complications during inpatient stay and mortality. European Quality of Life-5 Dimensions data and treatment costs were also collected.ResultsThe mean age of the 250 trial participants was 66 years and 192 (77%) were female. Independent assessment using the Neer classification identified 18 one-part fractures, 128 two-part fractures and 104 three- or four-part fractures. OSS data were available for 215 participants at 2 years. We found no statistically or clinically significant differences in OSS scores between the two treatment groups (scale 0–48, with a higher score indicating a better outcome) over the 2-year period [difference of 0.75 points in favour of the surgery group, 95% confidence interval (CI) –1.33 to 2.84;p = 0.479; data from 114 surgery and 117 non-surgery participants] or at individual time points. We found no statistically significant differences between surgical and non-surgical group participants in SF-12 physical or mental component summary scores; surgical or shoulder fracture-related complications (30 vs. 23 respectively); those undergoing further shoulder-related therapy, either surgery (11 vs. 11 respectively) or other therapy (seven vs. four respectively); or mortality (nine vs. five respectively). The base-case economic analysis showed that, at 2 years, the cost of surgical intervention was, on average, £1780.73 more per patient (95% CI £1152.71 to £2408.75) than the cost of non-surgical intervention. It was also slightly less beneficial in terms of utilities, although this difference was not statistically significant. The net monetary benefit associated with surgery is negative. There was only a 5% probability of surgery achieving the criterion of costing < £20,000 to gain a quality-adjusted life-year, which was confirmed by extensive sensitivity analyses.ConclusionsCurrent surgical practice does not result in a better outcome for most patients with displaced fractures of the proximal humerus involving the surgical neck and is not cost-effective in the UK setting. Two areas for future work are the setting up of a national database of these fractures, including the collection of patient-reported outcomes, and research on the best ways of informing patients with these and other upper limb fractures about initial self-care.Trial registrationCurrent Controlled Trials ISRCTN50850043.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 24. See the NIHR Journals Library website for further project information.

Observation Versus Prophylactic Antibiotics in Late Preterm Infants with Premature Rupture of Membranes: A Pragmatic Randomized Controlled Trial

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Han L ◽  
◽  
Shi J ◽  
Tang J ◽  
Wang H ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Bacterial Infections ◽  
Controlled Trial ◽  
Prophylactic Antibiotic ◽  
Prophylactic Antibiotics ◽  
Late Preterm ◽  
Premature Rupture Of Membranes ◽  
Premature Rupture ◽  
Late Preterm Infants ◽  
Significant Difference

Background: There is no general accepted strategy for the management of asymptomatic neonates born to mothers with Premature Rupture of Membranes (PROM). Objectives: To compare expectant observation versus prophylactic antibiotics in the management of infections in late preterm infants born to mothers with PROM. Methods: Infants between 34 and 36 weeks gestation weighting ≥1500 grams born to mothers with PROM were randomized to prophylactic antibiotic or expectant observation groups. Primary outcomes were the incidence of bacterial sepsis, and the incidence of systemic bacterial infection during hospitalization. Results: A total of 120 infants were enrolled. No significant difference in sepsis or systemic bacterial infections was found (RR 0.25, 95% CI 0.01 to 5.66, P=0.48; RR 0.80, 95% CI 0.23 to 2.84, P=0.73). The risk of readmission due to infection seemed higher in expectant group, without statistically significant difference (RR 5.10, 95% CI 0.58 to 45.12, P=0.14). Conclusions: Expectant observation strategy could be considered in late preterm infants born to mothers with PROM to reduce unnecessary consumption of antibiotics.

scholarly journals Use of single dose prophylactic antibiotic in routine abdominal hysterectomy - a randomized controlled trial

1970 ◽  
pp. 1-4
Author(s):  
Zaida Rahman
Keyword(s):  
Randomized Controlled Trial ◽  
Single Dose ◽  
Side Effects ◽  
Antimicrobial Therapy ◽  
Controlled Trial ◽  
Prophylactic Antibiotic ◽  
Abdominal Hysterectomy ◽  
Control Group ◽  
Case Group ◽  
Randomized Controlled

A randomized controlled trial was conducted in one unit of Gynecology and Obstetrics Dept. of a Govt. hospital by giving a single dose preoperative prophylactic antibiotic and the results were compared with a control group who received a conventional prophylactic regimen of antibiotic combination. A total of 60 samples were taken from the patients currently admitted and undergoing total abdominal hysterectomy in one unit of the Department of Obstetrics & Gynecology of a Govt. hospital for this trial and they were divided into two groups - 30 Cases and 30 Control. Case group were given a single dose cephradine 1 gm IV just before induction of anesthesia. Control group were given Inj. Ciprofloxacin 200 mg IV 12 hrsly plus inj. Metronidazol 500 mg 8 hrsly till oral feeding followed by oral tab. Ciprofloxacin 500 mg 12 hrsly plus tab. Metronidazol 400 mg 8 hrsly in the remaining days which was then practicing in that gynecology unit of the Govt. hospital. Variables measured for the trial were total cost and duration of antimicrobial therapy, rate of postoperative infection and side effects of antimicrobial therapy. While comparing the outcome between the case and control group, it was observed that both the duration and cost (P<0.001) and also the side effects (P<0.05) of antimicrobial therapy were significantly higher in control group than the case group (duration of antimicrobial therapy was 2.9± 0.88 days in case group and 8. 9±0.58 days in control group and cost of antimicrobial therapy was 113.06± 24.53 taka in case group and 957.376±32.05 taka in control group). But the rate of post operative infection which is the main objective of giving preoperative antibiotic prophylaxis, was significantly higher in case group than the control group (P<0.05). But this infection rate could be reduced if the sterilization procedure of the operation theatre and general conditions of the patients were improved. If these risk factors could be minimized, single dose preoperative prophylactic antibiotic could be effectively practiced in our country. DOI: 10.3329/bjpp.v22i1.3560 Bangladesh J Physiol Pharmacol 2006; 22(1/2) : 1-4

scholarly journals Comparative study on prophylactic antibiotic versus empirical antibiotic in prevention of surgical site infection

2019 ◽  
Vol 9 (2) ◽  
pp. 9-13
Author(s):  
S Rajarajan ◽  
T.H. Sreelekshmi Devi ◽  
Neeshma Mariam Simon ◽  
K.R. Navin Shankar ◽  
V. Ganesan
Keyword(s):  
Single Dose ◽  
Comparative Study ◽  
Surgical Site Infection ◽  
Hospital Stay ◽  
Prophylactic Antibiotic ◽  
Operative Therapy ◽  
Prophylactic Antibiotics ◽  
Control Group ◽  
P Value ◽  
Site Infection

The main aim of the study was to comparative study of single dose prophylactic antibiotic versus empirical postoperative antibiotics in prevention of surgical site infection. The study was a prospective observational study conducted over a period of 8months. A total of 100 number of surgery cases were selected randomly, to groups of 50 each. The study group received a single dose of antibiotic preoperatively while the control group received 3 to 5 days of empirical antibiotic therapy. Data analysis and statistical analysis was done with the help of graph pad prism trial version software. Student t test was carried out for paired analysis to find P value. There was no significant association of surgical site infection, grades of infection, and other complications. The hospital stay of patients, cost to the patients, and number of antibiotics used in patients were significantly more. The single dose prophylactic antibiotics are better than empirical post operative therapy in reducing the hospital stay and hospital cost to patients. Since the complete eradication of surgical site infection is not possible, only the reduction in infection rate can be achieved to a minimal level. Keywords: Prophylactic antibiotics, surgical site infection, surgical complications, post operative antibiotics.

Are routine antibiotics after operative vaginal birth beneficial?

2020 ◽  
Vol 58 (8) ◽  
pp. 115-115
Keyword(s):  
Randomised Controlled Trial ◽  
Vaginal Delivery ◽  
Controlled Trial ◽  
Prophylactic Antibiotics ◽  
Vaginal Birth ◽  
Prevention Of Infection ◽  
Operative Vaginal Delivery ◽  
Randomised Controlled

AbstractReview of: Knight M, Chiocchia V, Partlett C, et al. Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial. Lancet 2019;393:2395–403.

What Prophylactic Antibiotic (Type, Dose and Route of Administration) Should Be Administered Perioperatively for Patients Undergoing Total Ankle Arthroplasty (TAA)?

2019 ◽  
Vol 40 (1_suppl) ◽  
pp. 8S-9S ◽  
Author(s):  
Marisa Sanchez ◽  
Cecilia Losada
Keyword(s):  
Single Dose ◽  
Joint Infection ◽  
Prophylactic Antibiotic ◽  
Prophylactic Antibiotics ◽  
Total Ankle Arthroplasty ◽  
Site Infection ◽  
Beta Lactam ◽  
Level Of Evidence ◽  
Ankle Arthroplasty ◽  
Alternative Antibiotic

Recommendation: The administration of prophylactic antibiotics before total ankle arthroplasty (TAA) potentially reduces the incidence of surgical site infection (SSI) and/or periprosthetic joint infection (PJI). Weight-based (of at least 2 g) cefazolin administered intravenously within 60 minutes before the procedure can be an adequate choice for antibiotic prophylaxis. If the patient has a beta-lactam anaphylaxis, we recommend an appropriate alternative antibiotic effective against Staphylococcus. It is unclear whether prophylaxis should be given as a single dose or as multiple doses. Level of Evidence: Strong. Delegate Vote: Agree: 100%, Disagree: 0%, Abstain: 0% (Unanimous, Strongest Consensus)

scholarly journals A Randomized Controlled Trial of Ceftriaxone and Doxycycline, With or Without Metronidazole, for the Treatment of Acute Pelvic Inflammatory Disease

2020 ◽  
Author(s):  
Harold C Wiesenfeld ◽  
Leslie A Meyn ◽  
Toni Darville ◽  
Ingrid S Macio ◽  
Sharon L Hillier
Keyword(s):  
Single Dose ◽  
Pelvic Inflammatory Disease ◽  
Clinical Improvement ◽  
Inflammatory Disease ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Mycoplasma Genitalium ◽  
Double Blind ◽  
Randomized Controlled ◽  
Acute Pelvic Inflammatory Disease

Abstract Background Anaerobic organisms are important pathogens in acute pelvic inflammatory disease (PID). The currently recommended PID regimen of a single dose of ceftriaxone and doxycycline for 14 days has limited anaerobic activity. The need for broader anaerobic coverage is unknown and concerns have been raised about metronidazole tolerability. Methods We conducted a randomized, double-blind, placebo-controlled trial comparing ceftriaxone 250 mg intramuscular single dose and doxycycline for 14 days, with or without 14 days of metronidazole in women with acute PID. The primary outcome was clinical improvement at 3 days following enrollment. Additional outcomes at 30 days following treatment were the presence of anaerobic organisms in the endometrium, clinical cure (absence of fever and reduction in tenderness), adherence, and tolerability. Results We enrolled 233 women (116 to metronidazole and 117 to placebo). Clinical improvement at 3 days was similar between the 2 groups. At 30 days following treatment, anaerobic organisms were less frequently recovered from the endometrium in women treated with metronidazole than placebo (8% vs 21%, P &lt; .05) and cervical Mycoplasma genitalium was reduced (4% vs 14%, P &lt; .05). Pelvic tenderness was also less common among women receiving metronidazole (9% vs 20%, P &lt; .05). Adverse events and adherence were similar in each treatment group. Conclusions In women treated for acute PID, the addition of metronidazole to ceftriaxone and doxycycline was well tolerated and resulted in reduced endometrial anaerobes, decreased M. genitalium, and reduced pelvic tenderness compared to ceftriaxone and doxycycline. Metronidazole should be routinely added to ceftriaxone and doxycycline for the treatment of women with acute PID. Clinical Trials Registration NCT01160640.

scholarly journals The feasibility of early pulmonary rehabilitation and activity after COPD exacerbations: external pilot randomised controlled trial, qualitative case study and exploratory economic evaluation

2018 ◽  
Vol 22 (11) ◽  
pp. 1-204 ◽  
Author(s):  
Matthew Cox ◽  
Catherine O’Connor ◽  
Katie Biggs ◽  
Daniel Hind ◽  
Oscar Bortolami ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Economic Analysis ◽  
Health Technology Assessment ◽  
Usual Care ◽  
Technology Assessment ◽  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Health Technology ◽  
Randomised Controlled ◽  
The Uk

BackgroundChronic obstructive pulmonary disease (COPD) affects > 3 million people in the UK. Acute exacerbations of COPD (AECOPD) are the second most common reason for emergency hospital admission in the UK. Pulmonary rehabilitation is usual care for stable COPD but there is little evidence for early pulmonary rehabilitation (EPR) following AECOPD, either in hospital or immediately post discharge.ObjectiveTo assess the feasibility of recruiting patients, collecting data and delivering EPR to patients with AECOPD to evaluate EPR compared with usual care.DesignParallel-group, pilot 2 × 2 factorial randomised trial with nested qualitative research and an economic analysis.SettingTwo acute hospital NHS trusts. Recruitment was carried out from September 2015 to April 2016 and follow-up was completed in July 2016.ParticipantsEligible patients were those aged ≥ 35 years who were admitted with AECOPD, who were non-acidotic and who maintained their blood oxygen saturation level (SpO2) within a prescribed range. Exclusions included the presence of comorbidities that affected the ability to undertake the interventions.Interventions(1) Hospital EPR: muscle training delivered at the patient’s hospital bed using a cycle ergometer and (2) home EPR: a pulmonary rehabilitation programme delivered in the patient’s home. Both interventions were delivered by trained physiotherapists. Participants were allocated on a 1 : 1 : 1 : 1 ratio to (1) hospital EPR (n = 14), (2) home EPR (n = 15), (3) hospital EPR and home EPR (n = 14) and (4) control (n = 15). Outcome assessors were blind to treatment allocation; it was not possible to blind patients.Main outcome measuresFeasibility of recruiting 76 participants in 7 months at two centres; intervention delivery; views on intervention/research acceptability; clinical outcomes including the 6-minute walk distance (6WMD); and costs. Semistructured interviews with participants (n = 27) and research health professionals (n = 11), optimisation assessments and an economic analysis were also undertaken.ResultsOver 7 months 449 patients were screened, of whom most were not eligible for the trial or felt too ill/declined entry. In total, 58 participants (76%) of the target 76 participants were recruited to the trial. The primary clinical outcome (6MWD) was difficult to collect (hospital EPR,n = 5; home EPR,n = 6; hospital EPR and home EPR,n = 5; control,n = 5). Hospital EPR was difficult to deliver over 5 days because of patient discharge/staff availability, with 34.1% of the scheduled sessions delivered compared with 78.3% of the home EPR sessions. Serious adverse events were experienced by 26 participants (45%), none of which was related to the interventions. Interviewed participants generally found both interventions to be acceptable. Home EPR had a higher rate of acceptability, mainly because patients felt too unwell when in hospital to undergo hospital EPR. Physiotherapists generally found the interventions to be acceptable and valued them but found delivery difficult because of staffing issues. The health economic analysis results suggest that there would be value in conducting a larger trial to assess the cost-effectiveness of the hospital EPR and hospital EPR plus home EPR trial arms and collect more information to inform the hospital cost and quality-adjusted life-year parameters, which were shown to be key drivers of the model.ConclusionsA full-scale randomised controlled trial using this protocol would not be feasible. Recruitment and delivery of the hospital EPR intervention was difficult. The data obtained can be used to design a full-scale trial of home EPR. Because of the small sample and large confidence intervals, this study should not be used to inform clinical practice.Trial registrationCurrent Controlled Trials ISRCTN18634494.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 11. See the NIHR Journals Library website for further project information.

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