Publications by authors named "B C Reeves"

536 Publications

Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.

Health Technol Assess 2021 Sep;25(53):1-52

Editorial Department, The Lancet, London, UK.

Background: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges.

Objectives: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials.

Design: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout.

Setting: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines.

Results: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect.

Conclusions: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial.

Limitations: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS.

Future Work: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space.

Funding: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research programme.
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http://dx.doi.org/10.3310/hta25530DOI Listing
September 2021

Patient- and hospital-related risk factors for non-routine discharge after lumbar decompression and fusion for spondylolisthesis.

Clin Neurol Neurosurg 2021 Aug 21;209:106902. Epub 2021 Aug 21.

Department of Neurosurgery, John Hopkins School of Medicine, Baltimore, MD, USA; Department of Neurosurgery, Zucker School of Medicine at Hofstra, Long Island Jewish Medical Center and North Shore University Hospital, Northwell Health, Manhasset, NY 11030, USA.

Objective: In various spinal surgeries, non-routine discharges have been associated with inferior outcomes. However, there exists a paucity of data regarding the relationship between non-routine discharge and quality of care among patients with spondylolisthesis. The aim of this study was to identify independent predictors for non-routine discharge following spinal decompression and fusion for lumbar spondylolisthesis.

Methods: A retrospective cohort study was performed using the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database from 2010 through 2016. Adult patients (≥18 years old) who underwent spinal decompression and fusion for lumbar spondylolisthesis were identified using ICD-9-CM diagnosis and CPT procedural coding systems. The study population was divided into two cohorts based on discharge disposition: routine (RD) and non-routine discharge (NRD). Patient demographics, comorbidities, adverse events, LOS, reoperation, and readmission were assessed. A multivariate logistic regression model was used to identify the independent predictors of non-home discharge and 30-day unplanned readmission.

Results: A total of 5252 patients were identified, of which 4316 (82.2%) had a RD and 936 (18.8%) had a NRD. The NRD cohort tended to be older (p < 0.001) and have a higher BMI (p < 0.001). Patients who experienced a NRD had a longer LOS (NRD: 4.7 ± 3.7 days vs RD: 3.1 ± 2.0 days, p < 0.001), a higher proportion of adverse events (p < 0.001), higher rates of reoperation (p = 0.005) and unplanned 30-day readmission rates (p < 0.001). On multivariate regression analysis, age [OR: 1.08, 95% CI (1.06-1.10), p < 0.001], female sex [OR: 2.01, 95% (1.51-2.69), p < 0.001], non-Hispanic Black race/ethnicity [OR: 2.10, 95% CI (1.36-3.24), p = 0.001], BMI [OR: 1.03, 95% CI (1.01-1.05), p = 0.007], dependent functional status [OR: 3.33, 95% CI (1.59 - 6.99), p = 0.001], malnourishment [OR: 2.14, 95% CI (1.27-3.62), p = 0.005], and LOS [OR: 1.26, 95% CI (1.18-1.33), p < 0.001] were all independent predictors for NRD. However, NRD did not independently predict an unplanned 30-day readmission on multivariate analysis.

Conclusion: In our study we found that on univariate analysis NRD was associated with increased adverse events, length of stay and 30-day unplanned readmission. When controlling for patient- and hospital-related factors, we found that female sex, non-Hispanic Black race, BMI, dependent functional status, malnourishment and longer LOS were independently associated with NRD. However, NRD did not independently predict an unplanned 30-day readmission.
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http://dx.doi.org/10.1016/j.clineuro.2021.106902DOI Listing
August 2021

Single-View Echocardiography by Nonexpert Practitioners to Detect Rheumatic Heart Disease: A Prospective Study of Diagnostic Accuracy.

Circ Cardiovasc Imaging 2021 Aug 13;14(8):e011790. Epub 2021 Aug 13.

Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Australia (J.R.F., H.F., J.M., J.Y., A.P.R., B.R.).

Background: Echocardiographic screening can detect asymptomatic cases of rheumatic heart disease (RHD), facilitating access to treatment. Barriers to implementation of echocardiographic screening include the requirement for expensive equipment and expert practitioners. We aimed to evaluate the diagnostic accuracy of an abbreviated echocardiographic screening protocol (single parasternal-long-axis view with a sweep of the heart) performed by briefly trained, nonexpert practitioners using handheld ultrasound devices.

Methods: Participants aged 5 to 20 years in Timor-Leste and the Northern Territory of Australia had 2 echocardiograms: one performed by an expert echocardiographer using a GE Vivid I or Vivid Q portable ultrasound device (reference test), and one performed by a nonexpert practitioner using a GE Vscan handheld ultrasound device (index test). The accuracy of the index test, compared with the reference test, for identifying cases with definite or borderline RHD was determined.

Results: There were 3111 enrolled participants; 2573 had both an index test and reference test. Median age was 12 years (interquartile range, 10-15); 58.2% were female. Proportion with definite or borderline RHD was 5.52% (95% CI, 4.70-6.47); proportion with definite RHD was 3.23% (95% CI, 2.61-3.98). Compared with the reference test, sensitivity of the index test for definite or borderline RHD was 70.4% (95% CI, 62.2-77.8), specificity was 78.1% (95% CI, 76.4-79.8).

Conclusions: Nonexpert practitioners can be trained to perform single parasternal-long-axis view with a sweep of the heart echocardiography. However, the specificity and sensitivity are inadequate for echocardiographic screening. Improved training for nonexpert practitioners should be investigated.
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http://dx.doi.org/10.1161/CIRCIMAGING.120.011790DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8373443PMC
August 2021

Radiofrequency denervation of the lumbar facet joints: guidelines for the RADICAL randomised controlled trial.

Br J Pain 2021 Aug 17;15(3):251-258. Epub 2020 Jul 17.

Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK.

Background And Aim: The RADICAL trial has been funded by the National Institute for Health Research (NIHR) to evaluate the clinical and cost-effectiveness of radiofrequency denervation (RFD) for low back pain. Recommendations have been published which aim to standardise selection of patients and RFD technique. However, it is important to ensure these recommendations are acceptable to clinicians within the context of the trial. The aim of this work was to develop standardised criteria for the trial entry and RFD technique for implementation within the RADICAL trial.

Methods: Fourteen pain clinicians completed a survey, which involved reviewing the current recommendations and indicating whether they disagreed with any of the recommendations and if so why. Responses were collated and presented at a half-day workshop with 14 attendees. During the workshop, the National Low Back and Radicular Pain Pathway (NLBRPP) guidelines for patient selection and an article by Eldabe and colleagues presenting recommendations on the RFD technique were reviewed. Attendees discussed whether each component of the recommendations should be mandatory, mandatory with alteration or clarification or optional within the RADICAL trial.

Results: Attendees agreed during the workshop that 5 of the 10 criteria for patient selection described in the NLBRPP should be mandatory within the RADICAL trial. Three were agreed as mandatory criteria but required further clarification, one of which involved defining a positive response to a diagnostic medial branch block as ⩾60% pain relief. Two criteria had optional components. After reviewing the recommendations on the RFD technique from Eldabe and colleagues, seven components were agreed as mandatory, three were mandatory with alterations and three were optional.

Conclusion: When evaluating complex interventions, such as RFD, it is important to ensure agreement and clarity on the clinical protocol, so that the intervention can be reproduced, if found to be effective.
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http://dx.doi.org/10.1177/2049463720941053DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8339950PMC
August 2021

A semi-Markov model comparing the lifetime cost-effectiveness of mesh prophylaxis to prevent parastomal hernia in patients undergoing end colostomy creation for rectal cancer.

Colorectal Dis 2021 Jul 31. Epub 2021 Jul 31.

Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

Aim: Parastomal hernia (PSH) is a common problem following colostomy. Using prophylactic mesh during end colostomy creation may reduce PSH incidence, but concerns exist regarding the optimal type of mesh, potential long-term complications, and cost-effectiveness of its use. We evaluated the cost-effectiveness of mesh prophylaxis to prevent PSH in patients undergoing end colostomy creation for rectal cancer.

Methods: We developed a decision-analytical model, stratified by rectal cancer stages I-IV, to estimate the lifetime costs, quality-adjusted life-years (QALYs) and net monetary benefits (NMBs) of synthetic, biologic and no mesh from a UK NHS perspective. We pooled the mesh-related relative risks of PSH from 13 randomised controlled trials (RCTs) and superimposed these on the baseline (no mesh) risk from a population-based cohort. Uncertainty was assessed in sensitivity analyses.

Results: Synthetic mesh was less costly and more effective than biologic and no mesh to prevent PSH for all rectal cancer stages. At the willingness-to-pay threshold of £20,000/QALY, the incremental NMBs (95% CI) ranged between £3,412 (£3,384 to £3,439) (stage I) and £1,305 (£1,293 to £1,316) (stage IV) for synthetic versus no mesh, and £2,449 (£2,371 to £2,526) (stage I) and £1,784 (£1,753 to £1,815) (stage IV) for synthetic versus biologic mesh. Synthetic mesh was more cost-effective than no mesh unless the relative risk of PSH was ≥0.97 for stages I-III and ≥0.94 for stage IV.

Conclusions: Synthetic mesh was the most cost-effective strategy to prevent the formation of PSH in patients after end colostomy for any rectal cancer stage; however, conclusions are dependent on which subset of RCTs are considered to provide the most robust evidence.
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http://dx.doi.org/10.1111/codi.15848DOI Listing
July 2021
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