ABSTRACT
BACKGROUND: Controversy exists over the use of bone cement in hip fractures treated with hemiarthroplasty. Only limited data on quality of life after cemented as compared with modern uncemented hemiarthroplasties are available. METHODS: We conducted a multicenter, randomized, controlled trial comparing cemented with uncemented hemiarthroplasty in patients 60 years of age or older with an intracapsular hip fracture. The primary outcome was health-related quality of life measured with the use of utility scores on the EuroQol Group 5-Dimension (EQ-5D) questionnaire at 4 months after randomization (range of scores, -0.594 to 1, with higher scores indicating better quality of life; range for minimal clinically important difference, 0.050 to 0.075). RESULTS: A total of 610 patients were assigned to undergo cemented hemiarthroplasty and 615 to undergo modern uncemented hemiarthroplasty; follow-up data were available for 71.6% of the patients at 4 months. The mean EQ-5D utility score was 0.371 in patients assigned to the cemented group and 0.315 in those assigned to the uncemented group (adjusted difference, 0.055; 95% confidence interval [CI], 0.009 to 0.101; P = 0.02). The between-group difference at 1 month was similar to that at 4 months, but the difference at 12 months was smaller than that at 4 months. Mortality at 12 months was 23.9% in the cemented group and 27.8% in the uncemented group (odds ratio for death, 0.80; 95% CI, 0.62 to 1.05). Periprosthetic fractures occurred in 0.5% and 2.1% of the patients in the respective groups (odds ratio [uncemented vs. cemented], 4.37; 95% CI, 1.19 to 24.00). The incidences of other complications were similar in the two groups. CONCLUSIONS: Among patients 60 years of age or older with an intracapsular hip fracture, cemented hemiarthroplasty resulted in a modestly but significantly better quality of life and a lower risk of periprosthetic fracture than uncemented hemiarthroplasty. (Funded by the National Institute for Health Research; WHiTE 5 ISRCTN number, ISRCTN18393176.).
Subject(s)
Arthroplasty, Replacement, Hip/methods , Bone Cements , Femoral Neck Fractures/surgery , Hemiarthroplasty/methods , Periprosthetic Fractures/epidemiology , Quality of Life , Aged , Aged, 80 and over , Bone Cements/adverse effects , Female , Hemiarthroplasty/adverse effects , Humans , Kaplan-Meier Estimate , Male , Postoperative Complications/epidemiology , Risk FactorsABSTRACT
BACKGROUND: Hip fracture is the most common injury requiring treatment in hospital. Controversy exists regarding the use of antibiotic loaded bone cement in hip fractures treated with hemiarthroplasty. We aimed to compare the rate of deep surgical site infection in patients receiving high-dose dual-antibiotic loaded cement versus standard care single-antibiotic loaded cement. METHODS: We included people aged 60 years and older with a hip fracture attending 26 UK hospitals in this randomised superiority trial. Participants undergoing cemented hemiarthroplasty were randomly allocated in a 1:1 ratio to either a standard care single-antibiotic loaded cement or high-dose dual-antibiotic loaded cement. Participants and outcome assessors were masked to the treatment allocation. The primary outcome was deep surgical site infection at 90 days post-randomisation as defined by the US Centers for Disease Control and Prevention in an as-randomised population of consenting participants with available data at 120 days. Secondary outcomes were quality of life, mortality, antibiotic use, mobility, and residential status at day 120. The trial is registered with ISRCTN15606075. FINDINGS: Between Aug 17, 2018, and Aug 5, 2021, 4936 participants were randomly assigned to either standard care single-antibiotic loaded cement (2453 participants) or high-dose dual-antibiotic loaded cement (2483 participants). 38 (1·7%) of 2183 participants with follow-up data in the single-antibiotic loaded cement group had a deep surgical site infection by 90 days post-randomisation, as did 27 (1·2%) of 2214 participants in the high-dose dual-antibiotic loaded cement group (adjusted odds ratio 1·43; 95% CI 0·87-2·35; p=0·16). INTERPRETATION: In this trial, the use of high-dose dual-antibiotic loaded cement did not reduce the rate of deep surgical site deep infection among people aged 60 years or older receiving a hemiarthroplasty for intracapsular fracture of the hip. FUNDING: Heraeus Medical. Supported by the UK National Institute for Health and Care Research Oxford Biomedical Research Centre.
Subject(s)
Hemiarthroplasty , Hip Fractures , Humans , Middle Aged , Aged , Anti-Bacterial Agents/therapeutic use , Surgical Wound Infection/epidemiology , Quality of Life , Hip Fractures/surgery , United KingdomABSTRACT
BACKGROUND: The safety, effectiveness, and cost-effectiveness of molnupiravir, an oral antiviral medication for SARS-CoV-2, has not been established in vaccinated patients in the community at increased risk of morbidity and mortality from COVID-19. We aimed to establish whether the addition of molnupiravir to usual care reduced hospital admissions and deaths associated with COVID-19 in this population. METHODS: PANORAMIC was a UK-based, national, multicentre, open-label, multigroup, prospective, platform adaptive randomised controlled trial. Eligible participants were aged 50 years or older-or aged 18 years or older with relevant comorbidities-and had been unwell with confirmed COVID-19 for 5 days or fewer in the community. Participants were randomly assigned (1:1) to receive 800 mg molnupiravir twice daily for 5 days plus usual care or usual care only. A secure, web-based system (Spinnaker) was used for randomisation, which was stratified by age (<50 years vs ≥50 years) and vaccination status (yes vs no). COVID-19 outcomes were tracked via a self-completed online daily diary for 28 days after randomisation. The primary outcome was all-cause hospitalisation or death within 28 days of randomisation, which was analysed using Bayesian models in all eligible participants who were randomly assigned. This trial is registered with ISRCTN, number 30448031. FINDINGS: Between Dec 8, 2021, and April 27, 2022, 26 411 participants were randomly assigned, 12 821 to molnupiravir plus usual care, 12 962 to usual care alone, and 628 to other treatment groups (which will be reported separately). 12 529 participants from the molnupiravir plus usual care group, and 12 525 from the usual care group were included in the primary analysis population. The mean age of the population was 56·6 years (SD 12·6), and 24 290 (94%) of 25 708 participants had had at least three doses of a SARS-CoV-2 vaccine. Hospitalisations or deaths were recorded in 105 (1%) of 12 529 participants in the molnupiravir plus usual care group versus 98 (1%) of 12 525 in the usual care group (adjusted odds ratio 1·06 [95% Bayesian credible interval 0·81-1·41]; probability of superiority 0·33). There was no evidence of treatment interaction between subgroups. Serious adverse events were recorded for 50 (0·4%) of 12 774 participants in the molnupiravir plus usual care group and for 45 (0·3%) of 12 934 in the usual care group. None of these events were judged to be related to molnupiravir. INTERPRETATION: Molnupiravir did not reduce the frequency of COVID-19-associated hospitalisations or death among high-risk vaccinated adults in the community. FUNDING: UK National Institute for Health and Care Research.
Subject(s)
COVID-19 , Adult , Humans , Middle Aged , SARS-CoV-2 , COVID-19 Vaccines , Bayes Theorem , Prospective Studies , Treatment OutcomeABSTRACT
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. METHODS: A two-arm 1 : 1 parallel-group open multicentre superiority RCT was performed across 20 secondary-care hospitals in the UK. The co-primary outcomes were surgical-site infection at around 7 days after surgery and cosmetic appearance summary score at a minimum of 4 months. RESULTS: Some 451 children presenting with a suspected nail bed injury were recruited between July 2018 and July 2019; 224 were allocated to the nail-discarded arm, and 227 to the nail-replaced arm. There was no difference in the number of surgical-site infections at around 7 days between the two interventions or in cosmetic appearance. The mean total healthcare cost over the 4 months after surgery was 84 (95 per cent c.i. 34 to 140) lower for the nail-discarded arm than the nail-replaced arm (P < 0.001). CONCLUSION: After nail bed repair, discarding the fingernail was associated with similar rates of infection and cosmesis ratings as replacement of the finger nail, but was cost saving. Registration number: ISRCTN44551796 (http://www.controlled-trials.com).
Subject(s)
Nails , Surgical Wound Infection , Humans , Child , Nails/surgery , Nails/injuries , Surgical Wound Infection/etiology , Surgical Wound Infection/prevention & control , Treatment Outcome , Health Care Costs , Cost-Benefit AnalysisABSTRACT
BACKGROUND: Diabetes not only imposes a huge health burden but also a large economic burden worldwide. In the working-age population, cost of lost productivity can far exceed diabetes-related medical cost. In this study, we aimed to estimate the current and future indirect and excess direct costs of diagnosed type 2 diabetes among the working-age population in Singapore. METHODS: A previously-published epidemiological model of diabetes was adapted to forecast prevalence among working-age patients with diagnosed type 2 diabetes in the absence of interventions. The current methodology of the American Diabetes Association was adopted to estimate the costs of diabetes for this population. Diabetes-related excess direct medical costs were obtained from a local cost study while indirect costs were calculated using the human capital approach applied to local labor force statistics. These cost were estimated conservatively from a societal perspective on a per patient basis and projected to the overall Singapore population from 2010 to 2050. RESULTS: In 2010, total economic costs per working-age patient were estimated to be US$5,646 (US$4,432-US$10,612), of which 42% were excess direct medical costs and 58% indirect productivity-related losses. Total cost is projected to rise to US$7,791 (US$5,741-US$12,756) in 2050, with the share of indirect costs rising to 65%. Simultaneous increases in prevalence imply that the total economic costs of diabetes for the entire working-age population will increase by 2.4 fold from US$787 million in 2010 to US$1,867 million in 2050. CONCLUSIONS: By current projections, diabetes in Singapore represents a growing economic burden. Among the working-age population, the impact of productivity loss will become increasingly significant. Prevention efforts to reduce overall prevalence should also engage stakeholders outside the health sector who ultimately bear the indirect burden of disease.
Subject(s)
Cost of Illness , Diabetes Mellitus, Type 2/economics , Health Care Costs , Absenteeism , Adult , Aged , Asia , Efficiency , Female , Humans , Male , Middle Aged , Presenteeism , Prevalence , Sick Leave , Singapore , Young AdultABSTRACT
BACKGROUND: Microeconomic evaluations of public health programmes such as immunisation typically only consider direct health benefits and medical cost savings. Broader economic benefits around childhood development, household behaviour, and macro-economic indicators are increasingly important, but the evidence linking immunization to such benefits is unclear. METHODS: A conceptual framework of pathways between immunisation and its proposed broader economic benefits was developed through expert consultation. Relevant articles were obtained from previous reviews, snowballing, and expert consultation. Articles were associated with one of the pathways and quality assessed using modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. RESULTS: We found 20 studies directly relevant to one or more pathways. Evidence of moderate quality from experimental and observational studies was found for benefits due to immunisation in improved childhood physical development, educational outcomes, and equity in distribution of health gains. Only modelling evidence or evidence outside the immunization field supports extrapolating these benefits to household economic behaviour and macro-economic indicators. CONCLUSION: Innovative use of experimental and observational study designs is needed to fill evidence gaps around key pathways between immunisation and many of its proposed economic benefits.
Subject(s)
Vaccination/economics , Cost-Benefit Analysis , HumansABSTRACT
Background: Health economic assessments are used to determine whether the resources needed to generate net benefit from an antenatal or newborn screening programme, driven by multiple benefits and harms, are justifiable. It is not known what benefits and harms have been adopted by economic evaluations assessing these programmes and whether they omit benefits and harms considered important to relevant stakeholders. Objectives: (1) To identify the benefits and harms adopted by health economic assessments in this area, and to assess how they have been measured and valued; (2) to identify attributes or relevance to stakeholders that ought to be considered in future economic assessments; and (3) to make recommendations about the benefits and harms that should be considered by these studies. Design: Mixed methods combining systematic review and qualitative work. Systematic review methods: We searched the published and grey literature from January 2000 to January 2021 using all major electronic databases. Economic evaluations of an antenatal or newborn screening programme in one or more Organisation for Economic Co-operation and Development countries were considered eligible. Reporting quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards checklist. We identified benefits and harms using an integrative descriptive analysis and constructed a thematic framework. Qualitative methods: We conducted a meta-ethnography of the existing literature on newborn screening experiences, a secondary analysis of existing individual interviews related to antenatal or newborn screening or living with screened-for conditions, and a thematic analysis of primary data collected with stakeholders about their experiences with screening. Results: The literature searches identified 52,244 articles and reports, and 336 unique studies were included. Thematic framework resulted in seven themes: (1) diagnosis of screened for condition, (2) life-years and health status adjustments, (3) treatment, (4) long-term costs, (5) overdiagnosis, (6) pregnancy loss and (7) spillover effects on family members. Diagnosis of screened-for condition (115, 47.5%), life-years and health status adjustments (90, 37.2%) and treatment (88, 36.4%) accounted for most of the benefits and harms evaluating antenatal screening. The same themes accounted for most of the benefits and harms included in studies assessing newborn screening. Long-term costs, overdiagnosis and spillover effects tended to be ignored. The wide-reaching family implications of screening were considered important to stakeholders. We observed good overlap between the thematic framework and the qualitative evidence. Limitations: Dual data extraction within the systematic literature review was not feasible due to the large number of studies included. It was difficult to recruit healthcare professionals in the stakeholder's interviews. Conclusions: There is no consistency in the selection of benefits and harms used in health economic assessments in this area, suggesting that additional methods guidance is needed. Our proposed thematic framework can be used to guide the development of future health economic assessments evaluating antenatal and newborn screening programmes. Study registration: This study is registered as PROSPERO CRD42020165236. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR127489) and is published in full in Health Technology Assessment; Vol. 28, No. 25. See the NIHR Funding and Awards website for further award information.
Every year the NHS offers pregnant women screening tests to assess the chances of them or their unborn baby having or developing a health condition. It also offers screening tests for newborn babies to look for a range of health conditions. The implementation of screening programmes and the care for women and babies require many resources and funding for the NHS, so it is important that screening programmes represent good value for money. This means that the amount of money the NHS spends on a programme is justified by the amount of benefit that the programme gives. We wanted to see whether researchers consider all the important benefits and harms associated with screening of pregnant women and newborn babies when calculating value for money. To do this, we searched all studies available in developed countries to identify what benefits and harms they considered. We also considered the views of parents and healthcare professionals on the benefits and harms screening that creates for families and wider society. We found that the identification of benefits and harms of screening is complex because screening results affect a range of people (motherbaby, parents, extended family and wider society). Researchers calculating the value for money of screening programmes have, to date, concentrated on a narrow range of benefits and harms and ignored many factors that are important to people affected by screening results. From our discussions with parents and healthcare professionals, we found that wider impacts on families are an important consideration. Only one study we looked at considered wider impacts on families. Our work also found that parent's ability to recognise, absorb and apply new information to understand their child's screening results or condition is important. Healthcare professionals involve in screening should consider this when supporting families of children with a condition. We have created a list for researchers to identify the benefits and harms that are important to include in future studies. We have also identified different ways researchers can value these benefits and harms, so they are incorporated into their studies in a meaningful way.
Subject(s)
Cost-Benefit Analysis , Neonatal Screening , Humans , Infant, Newborn , Neonatal Screening/economics , Female , Pregnancy , Qualitative Research , Technology Assessment, Biomedical , Prenatal Diagnosis/economics , Quality-Adjusted Life YearsABSTRACT
Objective: Musculoskeletal pain is a common risk factor for co-morbid conditions and might increase the risk of poor outcomes. The objective was to determine whether patients with pre-existing musculoskeletal pain have an increased risk for mortality following a new diagnosis of a co-morbid condition. Methods: Patients aged ≥45 years with a new diagnosis of acute coronary syndrome (ACS), stroke, cancer, dementia or pneumonia recorded in a UK electronic primary care database linked to hospital and mortality records were examined. The association of mortality with musculoskeletal pain (inflammatory conditions, OA and regional pain) was determined. Results: The sample size varied from 128â649 (stroke) to 406â289 (cancer) by cohort, with 22-31% having pre-existing musculoskeletal conditions. In the ACS cohort, there was a higher rate of mortality for all musculoskeletal types. There were also higher unadjusted mortality rates in patients with inflammatory arthritis compared with those without musculoskeletal pain in the stroke, cancer and dementia cohorts and for patients with OA in the stroke and cancer cohorts. After adjustment for the number of prescribed medications and age, the increased risk of mortality remained only for patients with inflammatory arthritis in the ACS cohort (adjusted hazard ratio = 1.07; 95% CI 1.03, 1.10). Conclusion: Older adults with inflammatory arthritis and OA have increased risk of mortality when they develop a new condition, which seems to be related to the prescription of multiple medicines. Pre-existing musculoskeletal pain is an indicator of a complex patient who is at risk of poorer outcomes at the onset of new illnesses.
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BACKGROUND: The cost-effectiveness of molnupiravir, an oral antiviral for early treatment of SARS-CoV-2, has not been established in vaccinated populations. AIM: To evaluate the cost-effectiveness of molnupiravir relative to usual care alone among mainly vaccinated community-based people at higher risk of severe outcomes from COVID-19 over 6 months. DESIGN AND SETTING: An economic evaluation of the PANORAMIC trial in the UK. METHOD: A cost-utility analysis that adopted a UK NHS and personal social services perspective and a 6-month time horizon was performed using PANORAMIC trial data. Cost-effectiveness was expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. Sensitivity and subgroup analyses assessed the impacts of uncertainty and heterogeneity. Threshold analysis explored the price for molnupiravir consistent with likely reimbursement. RESULTS: In the base-case analysis, molnupiravir had higher mean costs of £449 (95% confidence interval [CI] = 445 to 453) and higher mean QALYs of 0.0055 (95% CI = 0.0044 to 0.0067) than usual care (mean incremental cost per QALY of £81 190). Sensitivity and subgroup analyses showed similar results, except for those aged ≥75 years, with a 55% probability of being cost-effective at a £30 000 per QALY threshold. Molnupiravir would have to be priced around £147 per course to be cost-effective at a £15 000 per QALY threshold. CONCLUSION: At the current cost of £513 per course, molnupiravir is unlikely to be cost-effective relative to usual care over a 6-month time horizon among mainly vaccinated patients with COVID-19 at increased risk of adverse outcomes, except those aged ≥75 years.
Subject(s)
Antiviral Agents , COVID-19 Drug Treatment , Cost-Benefit Analysis , Cytidine , Hydroxylamines , Quality-Adjusted Life Years , SARS-CoV-2 , Humans , Antiviral Agents/economics , Antiviral Agents/therapeutic use , Cytidine/analogs & derivatives , Cytidine/therapeutic use , Cytidine/economics , Hydroxylamines/therapeutic use , Hydroxylamines/economics , United Kingdom , COVID-19/prevention & control , COVID-19/economics , COVID-19/epidemiology , Adult , Middle Aged , Male , FemaleABSTRACT
Economic evaluation provides a framework for assessing the costs and consequences of alternative programmes or interventions. One common vehicle for economic evaluations in the healthcare context is the decision-analytic model, which synthesizes information on parameter inputs (for example, probabilities or costs of clinical events or health states) from multiple sources and requires application of mathematical techniques, usually within a software program. A plethora of decision-analytic modelling-based economic evaluations of orthopaedic interventions have been published in recent years. This annotation outlines a number of issues that can help readers, reviewers, and decision-makers interpret evidence from decision-analytic modelling-based economic evaluations of orthopaedic interventions.Cite this article: Bone Joint J 2023;105-B(1):17-20.
Subject(s)
Orthopedic Procedures , Orthopedics , Humans , Cost-Benefit Analysis , ProbabilityABSTRACT
Aims: To compare the cost-effectiveness of high-dose, dual-antibiotic cement versus single-antibiotic cement for the treatment of displaced intracapsular hip fractures in older adults. Methods: Using data from a multicentre randomized controlled trial (World Hip Trauma Evaluation 8 (WHiTE-8)) in the UK, a within-trial economic evaluation was conducted. Resource usage was measured over 120 days post randomization, and cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY), gained from the UK NHS and personal social services (PSS) perspective in the base-case analysis. Methodological uncertainty was addressed using sensitivity analysis, while decision uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves. Results: The base-case analysis showed that high-dose, dual-antibiotic cement had a significantly higher mean cost (£224 (95% confidence interval (CI) -408 to 855)) and almost the same QALYs (0.001 (95% CI -0.002 to 0.003)) relative to single-antibiotic cement from the UK NHS and PSS perspective. The probability of the high-dose, dual-antibiotic cement being cost-effective was less than 0.3 at alternative cost-effectiveness thresholds, and its net monetary benefit was negative. This finding remained robust in the sensitivity analyses. Conclusion: This study shows that high-dose, dual-antibiotic cement is unlikely to be cost-effective compared to single-antibiotic cement for the treatment of displaced intracapsular hip fractures in older adults.
Subject(s)
Anti-Bacterial Agents , Hip Fractures , Humans , Aged , Cost-Benefit Analysis , Anti-Bacterial Agents/therapeutic use , Hip Fractures/surgery , Quality-Adjusted Life YearsABSTRACT
Introduction: Neuropathic pain is prevalent among people after lower limb fracture surgery and is associated with lower health-related quality of life and greater disability. This study estimates the financial cost and pain medication use associated with neuropathic pain in this group. Methods: A secondary analysis using pain data collected over six postoperative months from participants randomised in the Wound Healing in Surgery for Trauma (WHiST) trial. Pain states were classified as pain-free, chronic non-neuropathic pain (NNP) or chronic neuropathic pain (NP). Cost associated with each pain state from a UK National Health Service (NHS) and personal social services (PSS) perspective were estimated by multivariate models based on multiple imputed data. Pain medication usage was analysed by pain state. Results: A total of 934 participants who provided either 3- or 6-months pain data were included. Compared to participants with NP, those with NNP (adjusted mean difference -£730, p = 0.38, 95% CI -2368 to 908) or were pain-free (adjusted mean difference -£716, p = 0.53, 95% CI -2929 to 1497) had lower costs from the NHS and PSS perspective in the first three postoperative months. Over the first three postoperative months, almost a third of participants with NP were prescribed opioids and 8% were prescribed NP medications. Similar trends were observed by 6 months postoperatively. Conclusion: This study found healthcare costs were higher amongst those with chronic NP compared to those who were pain-free or had chronic NNP. Opioids, rather than neuropathic pain medications, were commonly prescribed for NP over the first six postoperative months, contrary to clinical guidelines.
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OBJECTIVE: To investigate the impact of pre-existing painful musculoskeletal conditions on healthcare utilization and costs among patients with five common conditions: acute coronary syndrome (ACS), stroke, cancer, dementia and pneumonia. METHODS: Using primary and secondary care services data from electronic health records, a negative binomial regression model was used to compare resource use while a two-part model was used to compare costs across the five conditions, between those with and without a pre-existing musculoskeletal pain. RESULTS: The study included 760,792 patients (144,870 with ACS, 121,208 with stroke, 231,702 with cancer, 134,638 with dementia, and 128,374 with pneumonia) in the complete case analysis. Pre-existing musculoskeletal pain had an incident rate ratio of above one for most healthcare resources over the follow-up period and an adjusted additional mean cumulative total healthcare costs per patient of £674.59 (95%CI 570.30 to 778.87) for ACS; £613.34 (95%CI 496.87 to 729.82) for stroke; £459.26 (95%CI 376.60 to 541.91) for cancer; and £766.23 (95%CI 655.06 to 877.39) for dementia over five years after diagnosis; and £200.85 (95%CI 104.16 to 297.55) for pneumonia over one year after diagnosis compared to those without musculoskeletal pain. CONCLUSION: This study highlights that individuals with painful musculoskeletal conditions have higher healthcare utiliszation and costs than those without painful musculoskeletal conditions. Given the high occurrence of musculoskeletal pain in patients with other conditions, effective management strategies are needed to reduce the burden on healthcare resources.
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OBJECTIVE: Musculoskeletal painful conditions are a risk factor for cardiovascular disease (CVD), but less is known about whether musculoskeletal pain also worsens prognosis from CVD. The objective was to determine whether patients with musculoskeletal pain have poorer prognosis following acute coronary syndrome (ACS) or stroke. METHODS: The study utilised UK electronic primary care records (CPRD Aurum) with linkage to hospital and mortality records. Patients aged ≥45 years admitted to hospital with incident ACS/stroke were categorised by healthcare use for musculoskeletal pain (inflammatory conditions, osteoarthritis [OA], and regional pain) based on primary care consultations in the prior 24 months. Outcomes included mortality, length of stay, readmission and management of index condition (ACS/stroke). RESULTS: There were 171,670 patients with incident ACS and 138,512 with stroke; 30% consulted for musculoskeletal pain prior to ACS/stroke and these patients had more comorbidity than those without musculoskeletal pain. Rates of mortality and readmission, and length of stay were higher in those with musculoskeletal pain, particularly OA and inflammatory conditions, in ACS. Readmission was also higher for patients with musculoskeletal pain in stroke. However, increased risks associated with musculoskeletal pain did not remain after adjustment for age and polypharmacy. Inflammatory conditions were associated with increased likelihood of prescriptions for dual anti-platelets (ACS only) and anti-coagulants. CONCLUSIONS: Patients with musculoskeletal pain have higher rates of poor outcome from ACS which relates to being older but also increased polypharmacy. The high rates of comorbidity including polypharmacy highlight the complexity of patients with musculoskeletal pain who have new onset ACS/stroke.
Subject(s)
Acute Coronary Syndrome , Musculoskeletal Pain , Stroke , Humans , Acute Coronary Syndrome/complications , Cohort Studies , Musculoskeletal Pain/epidemiology , Electronic Health Records , Stroke/complications , Stroke/epidemiology , Prognosis , Risk FactorsABSTRACT
INTRODUCTION: There is an urgent need to determine the safety, effectiveness and cost-effectiveness of novel antiviral treatments for COVID-19 in vaccinated patients in the community at increased risk of morbidity and mortality from COVID-19. METHODS AND ANALYSIS: PANORAMIC is a UK-wide, open-label, prospective, adaptive, multiarm platform, randomised clinical trial that evaluates antiviral treatments for COVID-19 in the community. A master protocol governs the addition of new antiviral treatments as they become available, and the introduction and cessation of existing interventions via interim analyses. The first two interventions to be evaluated are molnupiravir (Lagevrio) and nirmatrelvir/ritonavir (Paxlovid). ELIGIBILITY CRITERIA: community-dwelling within 5 days of onset of symptomatic COVID-19 (confirmed by PCR or lateral flow test), and either (1) aged 50 years and over, or (2) aged 18-49 years with qualifying comorbidities. Registration occurs via the trial website and by telephone. Recruitment occurs remotely through the central trial team, or in person through clinical sites. Participants are randomised to receive either usual care or a trial drug plus usual care. Outcomes are collected via a participant-completed daily electronic symptom diary for 28 days post randomisation. Participants and/or their Trial Partner are contacted by the research team after days 7, 14 and 28 if the diary is not completed, or if the participant is unable to access the diary. The primary efficacy endpoint is all-cause, non-elective hospitalisation and/or death within 28 days of randomisation. Multiple prespecified interim analyses allow interventions to be stopped for futility or superiority based on prespecified decision criteria. A prospective economic evaluation is embedded within the trial. ETHICS AND DISSEMINATION: Ethical approval granted by South Central-Berkshire REC number: 21/SC/0393; IRAS project ID: 1004274. Results will be presented to policymakers and at conferences, and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN30448031; EudraCT number: 2021-005748-31.
Subject(s)
COVID-19 , Humans , Middle Aged , Aged , Antiviral Agents , SARS-CoV-2 , Prospective Studies , Treatment Outcome , Randomized Controlled Trials as TopicABSTRACT
AIMS: This study aims to estimate economic outcomes associated with 30-day deep surgical site infection (SSI) from closed surgical wounds in patients with lower limb fractures following major trauma. METHODS: Data from the Wound Healing in Surgery for Trauma (WHiST) trial, which collected outcomes from 1,547 adult participants using self-completed questionnaires over a six-month period following major trauma, was used as the basis of this empirical investigation. Associations between deep SSI and NHS and personal social services (PSS) costs (£, 2017 to 2018 prices), and between deep SSI and quality-adjusted life years (QALYs), were estimated using descriptive and multivariable analyses. Sensitivity analyses assessed the impact of uncertainty surrounding components of the economic analyses. RESULTS: Compared to participants without deep SSI, those with deep SSI had higher mean adjusted total NHS and PSS costs (adjusted mean difference £1,577 (95% confidence interval (CI) -951 to 4,105); p = 0.222), and lower mean adjusted QALYs (adjusted mean difference -0.015 (95% CI -0.032 to 0.002); p = 0.092) over six months post-injury, but this difference was not statistically significant. The results were robust to the sensitivity analyses performed. CONCLUSION: This study found worse economic outcomes during the first six months post-injury in participants who experience deep SSI following orthopaedic surgery for major trauma to the lower limb. However, the increase in cost associated with deep SSI was less than previously reported in the orthopaedic trauma literature. Cite this article: Bone Jt Open 2022;3(5):398-403.
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AIMS: The aim of this study was to compare the cost-effectiveness of surgical fixation with Kirschner (K-)wire ersus moulded casting after manipulation of a fracture of the distal radius in an operating theatre setting. METHODS: An economic evaluation was conducted based on data collected from the Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT2) multicentre randomized controlled trial in the UK. Resource use was collected at three, six, and 12 months post-randomization using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY) gained from an NHS and personal social services perspective. Sensitivity analyses were conducted to examine the robustness of cost-effectiveness estimates, and decision uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves. RESULTS: In the base case analysis, surgical fixation with K-wire was more expensive (£29.65 (95% confidence interval (CI) -94.85 to 154.15)) and generated lower QALYs (0.007 (95% CI -0.03 to 0.016)) than moulded casting, but this difference was not statistically significant. The probability of K-wire being cost-effective at a £20,000 per QALY cost-effectiveness threshold was 24%. The cost-effectiveness results remained robust in the sensitivity analyses. CONCLUSION: The findings suggest that surgical fixation with K-wire is unlikely to be a cost-effective alternative to a moulded cast in adults, following manipulation of a fracture of the distal radius in a theatre setting.Cite this article: Bone Joint J 2022;104-B(11):1225-1233.
Subject(s)
Fractures, Bone , Radius Fractures , Adult , Humans , Bone Wires , Cost-Benefit Analysis , Radius , Bone Plates , Fracture Fixation, Internal/methods , Radius Fractures/surgery , Fracture Fixation/methodsABSTRACT
OBJECTIVE: To assess wrist function, quality of life, and complications in adult patients with a dorsally displaced fracture of the distal radius, treated with either a moulded cast or surgical fixation with K-wires. DESIGN: Multicentre randomised clinical superiority trial, SETTING: 36 hospitals in the UK National Health Service (NHS). PARTICIPANTS: 500 adults aged 16 or over with a dorsally displaced fracture of the distal radius, randomised after manipulation of their fracture (255 to moulded cast; 245 to surgical fixation). INTERVENTIONS: Manipulation and moulded cast was compared with manipulation and surgical fixation with K-wires plus cast. Details of the application of the cast and the insertion of the K-wires were at the discretion of the treating surgeon, according to their normal clinical practice. MAIN OUTCOME MEASURES: The primary outcome measure was the Patient Rated Wrist Evaluation (PRWE) score at 12 months (five questions about pain and 10 about function and disability; overall score out of 100 (best score=0 and worst score=100)). Secondary outcomes were PRWE score at three and six months, quality of life, and complications, including the need for surgery due to loss of fracture position in the first six weeks. RESULTS: The mean age of participants was 60 years and 417 (83%) were women; 395 (79%) completed follow-up. No statistically significant difference in the PRWE score was seen at 12 months (cast group (n=200), mean 21.2 (SD 23.1); K-wire group (n=195), mean 20.7 (22.3); adjusted mean difference -0.34 (95% confidence interval -4.33 to 3.66), P=0.87). No difference was seen at earlier time points. In the cast group, 33 (13%) of participants needed surgical fixation for loss of fracture position in the first six weeks compared with one revision surgery in the K-wire group (odds ratio 0.02, 95% confidence interval 0.001 to 0.10). CONCLUSIONS: Among patients with a dorsally displaced distal radius fracture that needed manipulation, surgical fixation with K-wires did not improve patients' wrist function at 12 months compared with a cast. TRIAL REGISTRATION: ISRCTN registry ISRCTN11980540.
Subject(s)
Bone Wires , Casts, Surgical/statistics & numerical data , Fracture Fixation/statistics & numerical data , Radius Fractures/therapy , Adolescent , Adult , Female , Fracture Fixation/methods , Humans , Male , Middle Aged , Radius Fractures/physiopathology , Treatment Outcome , United Kingdom , Wrist Joint/physiopathology , Wrist Joint/surgery , Young AdultABSTRACT
BACKGROUND: Patients with a displaced fracture of the distal radius are frequently offered surgical fixation. Manipulation of the fracture and moulded plaster casting is an alternative treatment that avoids metal implants, but evidence of its effectiveness is lacking. OBJECTIVE: To compare functional outcomes, quality-of-life outcomes, complications and resource use among patients with a dorsally displaced fracture of the distal radius treated with manipulation and surgical fixation with Kirschner wires (K-wires) and those treated with manipulation and moulded cast. DESIGN: Pragmatic, superiority, multicentre, randomised controlled trial with a health economic evaluation. SETTING: A total of 36 orthopaedic trauma centres in the UK NHS. PARTICIPANTS: Patients (aged ≥ 16 years) treated for an acute dorsally displaced fracture of the distal radius were potentially eligible. Patients were excluded if their injury had occurred > 2 weeks previously, if the fracture was open, if it extended > 3 cm from the radiocarpal joint or if it required open reduction, or if the participant was unable to complete questionnaires. INTERVENTIONS: Participants were randomly assigned in theatre (1 : 1) to receive a moulded cast (i.e. the cast group) or surgical fixation with K-wires (i.e. the K-wire group) after fracture manipulation. MAIN OUTCOME MEASURES: The primary outcome measure was the Patient-Rated Wrist Evaluation score at 12 months, analysed on an intention-to-treat basis. Health-related quality of life was recorded using the EuroQol-5 Dimensions, five-level version, and resource use was recorded from a health and personal social care perspective. RESULTS: Between January 2017 and March 2019, 500 participants (mean age 60 years, 83% women) were randomly allocated to receive a moulded cast (n = 255) or surgical fixation with K-wire (n = 245) following a manipulation of their fracture. A total of 395 (80%) participants were included in the primary analysis at 12 months. There was no difference in the Patient-Rated Wrist Evaluation score at 1 year post randomisation [cast group: n = 200, mean score 21.2 (standard deviation 23.1); K-wire group: n = 195, mean score 20.7 (standard deviation 22.3); adjusted mean difference -0.34 (95% confidence interval -4.33 to 3.66); p = 0.87]. A total of 33 (13%) participants in the cast group required surgical fixation for loss of fracture position in the first 6 weeks, compared with one participant in the K-wire group (odds ratio 0.02, 95% confidence interval 0.001 to 0.10). The base-case cost-effectiveness analysis showed that manipulation and surgical fixation with K-wires had a higher mean cost than manipulation and a moulded cast, despite similar mean effectiveness. The use of K-wires is unlikely to be cost-effective, and sensitivity analyses found this result to be robust. LIMITATIONS: Because the interventions were identifiable, neither patients nor clinicians could be blind to their treatment. CONCLUSIONS: Surgical fixation with K-wires was not found to be superior to moulded casting following manipulation of a dorsally displaced fracture of the distal radius, as measured by Patient-Rated Wrist Evaluation score. However, one in eight participants treated in a moulded cast required surgery for loss of fracture reduction in the first 6 weeks. After a successful closed reduction, clinicians may consider a moulded cast as a safe and cost-effective alternative to surgical fixation with K-wires. FUTURE WORK: Further research should focus on optimal techniques for immobilisation and manipulation of this type of fracture, including optimal analgesia, and for rehabilitation of the patient after immobilisation. TRIAL REGISTRATION: This trial is registered as ISRCTN11980540 and UKCRN Portfolio 208830. 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. 26, No. 11. See the NIHR Journals Library website for further project information.
Many patients with a wrist fracture can be treated with a simple cast or splint. However, if the broken bones have moved out of position, patients are frequently offered a manipulation of the fracture to restore the position of the broken bones. The bones may then be held in place with metal implants while they heal. A moulded plaster cast, shaped to support the bones, is an alternative treatment that avoids metal implants, but there is little research to suggest which treatment is better. The Distal Radius Acute Fracture Fixation Trial 2 (DRAFFT 2) study compared surgical fixation with metal wires with a moulded cast for patients with a broken wrist. Half of the patients underwent surgical fixation and half were given the moulded cast. The decision about which treatment patients were given was made by chance using a computer to ensure a fair comparison. The patients in both groups described their own wrist function and quality of life in the first year after their treatment and these descriptions were compared. A total of 500 patients took part at 36 NHS hospitals in the UK. The patients treated with a moulded cast reported very similar wrist function and quality of life to that of the patients treated with surgical fixation. However, one in eight patients treated with the moulded cast later required surgery because their broken bones had fallen back out of position. This study showed that a moulded cast is as good as, but costs less than, surgical fixation for patients with a broken wrist in terms of wrist function. However, a small proportion of the patients treated with a moulded cast may require later surgery if the broken bones cannot be held in position by the cast alone.
Subject(s)
Bone Wires , Radius Fractures , Adolescent , Cost-Benefit Analysis , Female , Humans , Male , Middle Aged , Quality of Life , Radius Fractures/surgery , Surveys and QuestionnairesABSTRACT
BACKGROUND: Health economic assessments are used to determine whether the resources needed to generate net benefit from a screening programme, driven by multiple complex benefits and harms, are justifiable. We systematically identified the benefits and harms incorporated within economic assessments evaluating antenatal and newborn screening programmes. METHODS: For this systematic review and thematic analysis, we searched the published and grey literature from January 2000 to January 2021. Studies that included an economic evaluation of an antenatal or newborn screening programme in an OECD country were eligible. We identified benefits and harms using an integrative descriptive analysis, and illustrated a thematic framework. (Systematic review registration PROSPERO, CRD42020165236). FINDINGS: The searches identified 52,244 articles and reports and 336 (242 antenatal and 95 newborn) were included. Eighty-six subthemes grouped into seven themes were identified: 1) diagnosis of screened for condition, 2) life years and health status adjustments, 3) treatment, 4) long-term costs, 5) overdiagnosis, 6) pregnancy loss, and 7) spillover effects on family members. Diagnosis of screened for condition (115 studies, 47.5%), life-years and health status adjustments (90 studies, 37.2%) and treatment (88 studies, 36.4%) accounted for most of the benefits and harms evaluating antenatal screening. The same themes accounted for most of the benefits and harms included in studies assessing newborn screening. Overdiagnosis and spillover effects tended to be ignored. INTERPRETATION: Our proposed framework can be used to guide the development of future health economic assessments evaluating antenatal and newborn screening programmes, to prevent exclusion of important potential benefits and harms.