The clinical effectiveness of clarithromycin versus endoscopic sinus surgery for adults with chronic rhinosinusitis with and without nasal polyps (MACRO): a pragmatic, multicentre, three-arm, randomised, placebo-controlled phase 4 trial.

Background: A paucity of evidence regarding use of endoscopic sinus surgery and antibiotics in managing chronic rhinosinusitis has contributed to a five-times variation in endoscopic sinus surgery rates, as well as variation in the use of antibiotics. The main aim of the present trial was to compare the clinical effectiveness of endoscopic sinus surgery or 3 months of clarithromycin treatment alongside intranasal medication in adults with chronic rhinosinusitis with or without nasal polyps.

Methods: In this pragmatic, three-arm, randomised, placebo-controlled phase 4 trial, participants were recruited from 20 secondary and tertiary care sites in the UK.

Healthcare Professionals' Decision-Making Regarding Lumbar Fusion Surgery or Conservative Care for Adults With Severe, Persistent Low Back Pain: An Australian Cross-Sectional Survey Using Case Vignettes.

Study DesignCross-sectional Survey.ObjectivesThe objective of this study was to describe clinicians' decision-making regarding suitability of patient cases for lumbar fusion surgery or conservative care and the level of equipoise to randomise participants into a randomised controlled trial (RCT).MethodsAn online survey distributed via Australian professional networks to clinicians involved in low back pain care, collected data on clinical discipline, clinical experience, practice setting and preferred care of five patient case vignettes (ranging in age, pain duration, BMI, imaging findings, neurological signs/symptoms).

'Going through the motions'; a rich account of the complexity of the anterior cruciate ligament reconstruction pathway, a UK qualitative study.

Objectives: This study aimed to understand the lived experiences of patients on the anterior cruciate ligament reconstruction (ACLR) pathway up to 3 months before, 3 months after and 1 year after surgery. Study objectives were to explore (1) patient experiences of preoperative and postoperative treatment, (2) views of/involvement in prehabilitation and (3) sources and consistency of healthcare advice.

Design: Semi-structured interviews analysed using reflexive thematic analysis.

Lumbar spine fusion surgery versus best conservative care for patients with severe, persistent low back pain.

Aims: People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians' views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial).

Clinical assessment and management of lumbar spinal stenosis: clinical dilemmas and considerations for surgical referral.

Lumbar spinal stenosis is the leading indication for spine surgery in older adults. Surgery is recommended in clinical guidelines if non-surgical treatments have been provided with insufficient benefit. The difficulty for clinicians is that the current number of randomised controlled trials is low, which creates uncertainty about which treatments to provide.

Implementing a shared decision-making intervention to support treatment decisions for patients following an anterior cruciate ligament rupture - a protocol for the POP-ACLR feasibility study.

Background: Treatment for anterior cruciate ligament (ACL) rupture may follow a surgical or nonsurgical pathway. At present, there is uncertainty around treatment choice. Two shared decision-making tools have been codesigned to support patients to make a decision about treatment following an ACL rupture.

The IDEAL framework for surgical robotics: development, comparative evaluation and long-term monitoring.

The next generation of surgical robotics is poised to disrupt healthcare systems worldwide, requiring new frameworks for evaluation. However, evaluation during a surgical robot's development is challenging due to their complex evolving nature, potential for wider system disruption and integration with complementary technologies like artificial intelligence. Comparative clinical studies require attention to intervention context, learning curves and standardized outcomes.

Cost-effectiveness analysis of a pragmatic randomized trial evaluating surgical reconstruction versus rehabilitation in patients with long-standing anterior cruciate ligament injury.

Aims: The aim of this study was to estimate the incremental use of resources, costs, and quality of life outcomes associated with surgical reconstruction compared to rehabilitation for long-standing anterior cruciate ligament (ACL) injury in the NHS, and to estimate its cost-effectiveness.

Methods: A total of 316 patients were recruited and randomly assigned to either surgical reconstruction or rehabilitation (physiotherapy but with subsequent reconstruction permitted if instability persisted after treatment). Healthcare resource use and health-related quality of life data (EuroQol five-dimension five-level health questionnaire) were collected in the trial at six, 12, and 18 months using self-reported questionnaires and medical records.

Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression.

Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has experienced common issues affecting the implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19 pandemic.

How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? A systematic review.

Introduction: Randomised controlled trials (RCTs) with a placebo comparator are considered the gold standard study design when evaluating healthcare interventions. These are challenging to design and deliver in surgery. Guidance recommends pilot and feasibility work to optimise main trial design and conduct; however, the extent to which this occurs in surgery is unknown.

Epidemiology of revision hip replacement surgery in the UK over the past 15 years-an analysis from the National Joint Registry.

Objectives: To investigate trends in the incidence rate and main indication for revision hip replacement (rHR) over the past 15 years in the UK.

Design: Repeated national cross-sectional study from 2006 to 2020.

Setting/participants: rHR procedures were identified from the National Joint Registry for England, Wales, Northern Ireland, the Isle of Man and the States of Guernsey.

Overcoming floor and ceiling effects in knee arthroplasty outcome measurement.

Aims: To map the Oxford Knee Score (OKS) and High Activity Arthroplasty Score (HAAS) items to a common scale, and to investigate the psychometric properties of this new scale for the measurement of knee health.

Methods: Patient-reported outcome measure (PROM) data measuring knee health were obtained from the NHS PROMs dataset and Total or Partial Knee Arthroplasty Trial (TOPKAT). Assumptions for common scale modelling were tested.

Remote Symptom Monitoring With Ecological Momentary Computerized Adaptive Testing: Pilot Cohort Study of a Platform for Frequent, Low-Burden, and Personalized Patient-Reported Outcome Measures.

Background: Remote patient-reported outcome measure (PROM) data capture can provide useful insights into research and clinical practice and deeper insights can be gained by administering assessments more frequently, for example, in ecological momentary assessment. However, frequent data collection can be limited by the burden of multiple, lengthy questionnaires. This burden can be reduced with computerized adaptive testing (CAT) algorithms that select only the most relevant items from a PROM for an individual respondent.

Patient-Relevant Outcomes Following First Revision Total Knee Arthroplasty, by Diagnosis: An Analysis of Implant Survivorship, Mortality, Serious Medical Complications, and Patient-Reported Outcome Measures Utilizing the National Joint Registry Data Set.

Background: The purpose of this study was to investigate patient-relevant outcomes following first revision total knee arthroplasties (rTKAs) performed for different indications.

Methods: This population-based cohort study utilized data from the United Kingdom National Joint Registry, Hospital Episode Statistics Admitted Patient Care, National Health Service Patient-Reported Outcome Measures, and the Civil Registrations of Death. Patients undergoing a first rTKA between January 1, 2009, and June 30, 2019, were included in our data set.

Patient-relevant outcomes following elective, aseptic revision knee arthroplasty: a systematic review.

Background: The aim of this systematic review was to summarise the evidence for the clinical effectiveness of revision knee arthroplasty (rKA) compared to non-operative treatment for the management of patients with elective, aseptic causes for a failed knee arthroplasty.

Methods: MEDLINE, Embase, AMED and PsychINFO were searched from inception to 1st December 2020 for studies on patients considering elective, aseptic rKA. Patient-relevant outcomes (PROs) were defined as implant survivorship, joint function, quality of life (QoL), complications and hospital admission impact.

Item response theory assumptions were adequately met by the Oxford hip and knee scores.

Objectives: To develop item response theory (IRT) models for the Oxford hip and knee scores which convert patient responses into continuous scores with quantifiable precision and provide these as web applications for efficient score conversion.

Study Design And Setting: Data from the National Health Service patient-reported outcome measures program were used to test the assumptions of IRT (unidimensionality, monotonicity, local independence, and measurement invariance) before fitting models to preoperative response patterns obtained from patients undergoing primary elective hip or knee arthroplasty. The hip and knee datasets contained 321,147 and 355,249 patients, respectively.

Item response theory may account for unequal item weighting and individual-level measurement error in trials that use PROMs: a psychometric sensitivity analysis of the TOPKAT trial.

Objectives: To apply item response theory as a framework for studying measurement error in superiority trials which use patient-reported outcome measures (PROMs).

Methods: We reanalyzed data from the The Total or Partial Knee Arthroplasty Trial, which compared the Oxford Knee Score (OKS) responses of patients undergoing partial or total knee replacement, using traditional sum-scoring, after accounting for OKS item characteristics with expected a posteriori (EAP) scoring, and after accounting for individual-level measurement error with plausible value imputation (PVI). We compared the marginalized mean scores of each group at baseline, 2 months, and yearly for 5 years.

Effectiveness of nail bed repair in children with or without replacing the fingernail: NINJA multicentre randomized clinical trial.

Background: Surgery for nail bed injuries in children is common. One of the key surgical decisions is whether to replace the nail plate following nail bed repair. The aim of this RCT was to assess the clinical effectiveness and cost-effectiveness of nail bed repair with fingernail replacement/substitution compared with repair without fingernail replacement.

Group sequential designs in pragmatic trials: feasibility and assessment of utility using data from a number of recent surgical RCTs.

Background: Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions.