scholarly journals Lower limb arthroplasty: can we produce a tool to predict outcome and failure, and is it cost-effective? An epidemiological study

2017 ◽  
Vol 5 (12) ◽  
pp. 1-246 ◽  
Author(s):  
Nigel Arden ◽  
Doug Altman ◽  
David Beard ◽  
Andrew Carr ◽  
Nicholas Clarke ◽  
...  
Keyword(s):  
Risk Factors ◽  
Markov Model ◽  
Lower Limb ◽  
Prospective Cohort ◽  
Cost Effective ◽  
Preoperative Pain ◽  
Predictive Tool ◽  
Predictive Tools ◽  
Increased Risk ◽  
Patient Reported

BackgroundAlthough hip and knee arthroplasties are considered to be common elective cost-effective operations, up to one-quarter of patients are not satisfied with the operation. A number of risk factors for implant failure are known, but little is known about the predictors of patient-reported outcomes.Objectives(1) Describe current and future needs for lower limb arthroplasties in the UK; (2) describe important risk factors for poor surgery outcomes and combine them to produce predictive tools (for hip and knee separately) for poor outcomes; (3) produce a Markov model to enable a detailed health economic analysis of hip/knee arthroplasty, and for implementing the predictive tool; and (4) test the practicality of the prediction tools in a pragmatic prospective cohort of lower limb arthroplasty.DesignThe programme was arranged into four work packages. The first three work packages used the data from large existing data sets such as Clinical Practice Research Datalink, Hospital Episode Statistics and the National Joint Registry. Work package 4 established a pragmatic cohort of lower limb arthroplasty to test the practicality of the predictive tools developed within the programme.ResultsThe estimated number of total knee replacements (TKRs) and total hip replacements (THRs) performed in the UK in 2015 was 85,019 and 72,418, respectively. Between 1991 and 2006, the estimated age-standardised rates (per 100,000 person-years) for a THR increased from 60.3 to 144.6 for women and from 35.8 to 88.6 for men. The rates for TKR increased from 42.5 to 138.7 for women and from 28.7 to 99.4 for men. The strongest predictors for poor outcomes were preoperative pain/function scores, deprivation, age, mental health score and radiographic variable pattern of joint space narrowing. We found a weak association between body mass index (BMI) and outcomes; however, increased BMI did increase the risk of revision surgery (a 5-kg/m2rise in BMI increased THR revision risk by 10.4% and TKR revision risk by 7.7%). We also confirmed that osteoarthritis (OA) severity and migration pattern of the hip predicted patient-reported outcome measures. The hip predictive tool that we developed performed well, with a correctedR2of 23.1% and had good calibration, with only slight overestimation of Oxford Hip Score in the lowest decile of outcome. The knee tool developed performed less well, with a correctedR2of 20.2%; however, it had good calibration. The analysis was restricted by the relatively limited number of variables available in the extant data sets, something that could be addressed in future studies. We found that the use of bisphosphonates reduced the risk of revision knee and hip surgery by 46%. Hormone replacement therapy reduced the risk by 38%, if used for at least 6 months postoperatively. We found that an increased risk of postoperative fracture was prevented by bisphosphonate use. This result, being observational in nature, will require confirmation in a randomised controlled trial. The Markov model distinguished between outcome categories following primary and revision procedures. The resulting outcome prediction tool for THR and TKR reduced the number and proportion of unsatisfactory outcomes after the operation, saving NHS resources in the process. The highest savings per quality-adjusted life-year (QALY) forgone were reported from the oldest patient subgroups (men and women aged ≥ 80 years), with a reported incremental cost-effectiveness ratio of around £1200 saved per QALY forgone for THRs. In the prospective cohort of arthroplasty, the performance of the knee model was modest (R2 = 0.14) and that of the hip model poor (R2 = 0.04). However, the addition of the radiographic OA variable improved the performance of the hip model (R2 = 0.125 vs. 0.110) and high-sensitivity C-reactive protein improved the performance of the knee model (R2 = 0.230 vs. 0.216). These data will ideally need replication in an external cohort of a similar design. The data are not necessarily applicable to other health systems or countries.ConclusionThe number of total hip and knee replacements will increase in the next decade. High BMI, although clinically insignificant, is associated with an increased risk of revision surgery and postoperative complications. Preoperative pain/function, the pattern of joint space narrowing, deprivation index and level of education were found to be the strongest predictors for THR. Bisphosphonates and hormone therapy proved to be beneficial for patients undergoing lower limb replacement. The addition of new predictors collected from the prospective cohort of arthroplasty slightly improved the performance of the predictive tools, suggesting that the potential improvements in both tools can be achieved using the plethora of extra variables from the validation cohort. Although currently it would not be cost-effective to implement the predictive tools in a health-care setting, we feel that the addition of extensive risk factors will improve the performances of the predictive tools as well as the Markov model, and will prove to be beneficial in terms of cost-effectiveness. Future analyses are under way and awaiting more promising provisional results.Future workFurther research should focus on defining and predicting the most important outcome to the patient.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

The Susceptibility of Healthy People to COVID-19 Infection and the Role of ACE2

2021 ◽  
Author(s):  
Mehdi Kushkestani ◽  
Mohsen Parvani ◽  
Bakhtyar Tartibian ◽  
Rasoul Eslami
Keyword(s):  
Risk Factors ◽  
Cost Effective ◽  
Normal Subjects ◽  
Definitive Treatment ◽  
Activity Levels ◽  
Cost Effective Approach ◽  
Increased Risk ◽  
Physical Activity Levels ◽  
Ace2 Gene

The COVID-19 virus has caused many deaths of people worldwide since the pandemic began. However, no definitive treatment for this infection has been discovered so far. It has been shown that comorbidities such as diabetes, hypertension and cardiovascular diseases are associated with an increased risk of SARS-COV-2 infection. Interestingly, SARS-COV-2, like SARS-COV, uses the ACE2 gene to enter the host cell. Also, changes or imbalance in ACE2.ACE can affect SARS-COV-2 susceptibility, related outcomes and mortality. Regarding the crucial role of ACE2 protein in COVID-19 infection, the effect of different factors such as age, BMI, physical activity levels, nutritional status, altitude, as well as blood group was assessed on the level of this protein. Further, to our knowledge, no study has been conducted to examine factors that increase or decrease the risk of COVID-19 and its related severity and outcome in normal subjects emphasizing the pivotal role of ACE2. Therefore, the primary purpose of this study was to investigate the involved mechanisms of ACE2 protein and other risk factors causing infection in different situations and finally, to introduce a safe, accurate, and cost-effective approach to prevent SARS-COV-2 infection and hard clinical outcomes in normal subjects.

scholarly journals Different strategies for pharmacological thromboprophylaxis for lower-limb immobilisation after injury: systematic review and economic evaluation

2019 ◽  
Vol 23 (63) ◽  
pp. 1-190 ◽  
Author(s):  
Abdullah Pandor ◽  
Daniel Horner ◽  
Sarah Davis ◽  
Steve Goodacre ◽  
John W Stevens ◽  
...  
Keyword(s):  
Risk Factors ◽  
Lower Limb ◽  
Meta Analysis ◽  
Cost Effective ◽  
Health Technology ◽  
Risk Of Bleeding ◽  
Prognostic Accuracy ◽  
Risk Predictors ◽  
Qaly Threshold ◽  
Pharmacological Thromboprophylaxis

Background Thromboprophylaxis can reduce the risk of venous thromboembolism (VTE) during lower-limb immobilisation, but it is unclear whether or not this translates into meaningful health benefit, justifies the risk of bleeding or is cost-effective. Risk assessment models (RAMs) could select higher-risk individuals for thromboprophylaxis. Objectives To determine the clinical effectiveness and cost-effectiveness of different strategies for providing thromboprophylaxis to people with lower-limb immobilisation caused by injury and to identify priorities for future research. Data sources Ten electronic databases and research registers (MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects, the Cochrane Central Register of Controlled Trials, Health Technology Assessment database, NHS Economic Evaluation Database, Science Citation Index Expanded, ClinicalTrials.gov and the International Clinical Trials Registry Platform) were searched from inception to May 2017, and this was supplemented by hand-searching reference lists and contacting experts in the field. Review methods Systematic reviews were undertaken to determine the effectiveness of pharmacological thromboprophylaxis in lower-limb immobilisation and to identify any study of risk factors or RAMs for VTE in lower-limb immobilisation. Study quality was assessed using appropriate tools. A network meta-analysis was undertaken for each outcome in the effectiveness review and the results of risk-prediction studies were presented descriptively. A modified Delphi survey was undertaken to identify risk predictors supported by expert consensus. Decision-analytic modelling was used to estimate the incremental cost per quality-adjusted life-year (QALY) gained of different thromboprophylaxis strategies from the perspectives of the NHS and Personal Social Services. Results Data from 6857 participants across 13 trials were included in the meta-analysis. Thromboprophylaxis with low-molecular-weight heparin reduced the risk of any VTE [odds ratio (OR) 0.52, 95% credible interval (CrI) 0.37 to 0.71], clinically detected deep-vein thrombosis (DVT) (OR 0.40, 95% CrI 0.12 to 0.99) and pulmonary embolism (PE) (OR 0.17, 95% CrI 0.01 to 0.88). Thromboprophylaxis with fondaparinux (Arixtra®, Aspen Pharma Trading Ltd, Dublin, Ireland) reduced the risk of any VTE (OR 0.13, 95% CrI 0.05 to 0.30) and clinically detected DVT (OR 0.10, 95% CrI 0.01 to 0.94), but the effect on PE was inconclusive (OR 0.47, 95% CrI 0.01 to 9.54). Estimates of the risk of major bleeding with thromboprophylaxis were inconclusive owing to the small numbers of events. Fifteen studies of risk factors were identified, but only age (ORs 1.05 to 3.48), and injury type were consistently associated with VTE. Six studies of RAMs were identified, but only two reported prognostic accuracy data for VTE, based on small numbers of patients. Expert consensus was achieved for 13 risk predictors in lower-limb immobilisation due to injury. Modelling showed that thromboprophylaxis for all is effective (0.015 QALY gain, 95% CrI 0.004 to 0.029 QALYs) with a cost-effectiveness of £13,524 per QALY, compared with thromboprophylaxis for none. If risk-based strategies are included, it is potentially more cost-effective to limit thromboprophylaxis to patients with a Leiden thrombosis risk in plaster (cast) [L-TRiP(cast)] score of ≥ 9 (£20,000 per QALY threshold) or ≥ 8 (£30,000 per QALY threshold). An optimal threshold on the L-TRiP(cast) receiver operating characteristic curve would have sensitivity of 84–89% and specificity of 46–55%. Limitations Estimates of RAM prognostic accuracy are based on weak evidence. People at risk of bleeding were excluded from trials and, by implication, from modelling. Conclusions Thromboprophylaxis for lower-limb immobilisation due to injury is clinically effective and cost-effective compared with no thromboprophylaxis. Risk-based thromboprophylaxis is potentially optimal but the prognostic accuracy of existing RAMs is uncertain. Future work Research is required to determine whether or not an appropriate RAM can accurately select higher-risk patients for thromboprophylaxis. Study registration This study is registered as PROSPERO CRD42017058688. Funding The National Institute for Health Research Health Technology Assessment programme.

scholarly journals Risk Factors for Cholecystectomy After Laparoscopic Roux-En-Y Gastric Bypass

2019 ◽  
Vol 30 (2) ◽  
pp. 507-514 ◽  
Author(s):  
Sylke Haal ◽  
Djoeke Rondagh ◽  
Barbara A. Hutten ◽  
Yair I. Z. Acherman ◽  
Arnold W. J. M. van de Laar ◽  
...  
Keyword(s):  
Risk Factors ◽  
Gastric Bypass ◽  
Pain Syndrome ◽  
Female Gender ◽  
Dose Effect ◽  
Preoperative Pain ◽  
Retrospective Case ◽  
Increased Risk ◽  
Risk Patients ◽  
Traditional Risk Factors

Abstract Background Patients who have undergone bariatric surgery are at risk for subsequent cholecystectomy. We aimed to identify risk factors for cholecystectomy after laparoscopic Roux-en-Y gastric bypass (LRYGB). Methods We conducted a retrospective case-control study of patients who underwent LRYGB between 2013 and 2015. Cases underwent cholecystectomy because of biliary symptoms after LRYGB. For each case, two controls were selected without subsequent cholecystectomy. Logistic regression analyses were used to identify risk factors. Results Between 2013 and 2015, 1780 primary LRYGBs were performed. We identified 233 (13.1%) cases who had undergone cholecystectomy after a median (IQR) of 12 (8–17) months, and 466 controls. Female gender (OR (95% CI) 1.83 (1.06–3.17)), Caucasian ethnicity (OR (95% CI) 1.82 (1.10–3.02)), higher percent total weight loss (%TWL) at 12 months (OR (95% CI) 1.06 (1.04–1.09)), and preoperative pain syndrome (OR (95% CI) 2.72 (1.43–5.18)) were significantly associated with an increased risk for cholecystectomy. Older age (OR (95% CI) 0.98 (0.96–0.99)) and preoperative statin use were associated with a reduced risk (OR (95% CI) 0.56 (0.31–1.00)). A dose-effect relationship was found between the intensity of preoperative statin and risk for cholecystectomy. Conclusions In our study, higher %TWL and preoperative pain syndrome were associated with an increased risk for cholecystectomy besides the traditional risk factors female gender and Caucasian ethnicity. These factors can be used to identify high-risk patients, who might benefit from preventive measures. Whether statins can protect bariatric patients from developing gallstones should be investigated prospectively.

scholarly journals Risk Factors for Alanine Aminotransferase Elevations in a Prospective Cohort of HIV-Infected Tanzanian Adults Initiating Antiretroviral Therapy

2019 ◽  
Vol 18 ◽  
pp. 232595821988493
Author(s):  
Sabina F. Mugusi ◽  
David Sando ◽  
Ferdinand M. Mugusi ◽  
Claudia Hawkins ◽  
Said Aboud ◽  
...  
Keyword(s):  
Risk Factors ◽  
Antiretroviral Therapy ◽  
Alanine Aminotransferase ◽  
Prospective Cohort ◽  
Combination Antiretroviral Therapy ◽  
Demographic Information ◽  
P Values ◽  
Increased Risk ◽  
Male Sex

Introduction: Serum alanine aminotransferase (ALT) elevations are common among HIV-infected patients on combination antiretroviral therapy (cART). Approach: We conducted a prospective cohort study of 3023 HIV-infected Tanzanian adults initiating cART. We assessed risk factors for mild/moderate ALT elevations >40 IU/L and severe ALT elevations >200 IU/L. Results: We found that over a median follow-up of 32.5 months (interquartile range: 19.4-41.5), 44.8% of participants had at least 1 incident ALT elevation >40 IU/L of which 50.1% were persistent elevations. Risk factors for incident ALT elevation >40 IU/L included male sex, CD4 count <100 cells/μL, d4T+3TC+NVP cART, and triglycerides ≥150 mg/dL ( P values <.05). Hepatitis B coinfection and alcohol consumption increased the risk of severe ALT elevations >200 IU/L ( P values: <.05). Conclusion: Incident mild and moderate ALT elevations are common among Tanzanians initiating cART, and the clinical and demographic information can identify patients at increased risk.

scholarly journals Surgical prehabilitation using mobile health coaching in patients with obesity: A pilot study

2020 ◽  
Vol 48 (5) ◽  
pp. 373-380
Author(s):  
Kasia Kulinski ◽  
Natalie A Smith
Keyword(s):  
Risk Factors ◽  
Mobile Health ◽  
Elective Surgery ◽  
Text Message ◽  
Cost Effective ◽  
Text Messages ◽  
Morbidity And Mortality ◽  
Perioperative Morbidity ◽  
Increased Risk ◽  
Patient Health

Many patients spend months waiting for elective procedures, and many have significant modifiable risk factors that could contribute to an increased risk of perioperative morbidity and mortality. The minimal direct contact that usually occurs with healthcare professionals during this period represents a missed opportunity to improve patient health and surgical outcomes. Patients with obesity comprise a large proportion of the surgical workload but are under-represented in prehabilitation studies. Our study piloted a mobile phone based, multidisciplinary, prehabilitation programme for patients with obesity awaiting elective surgery. A total of 22 participants were recruited via the Wollongong Hospital pre-admissions clinic in New South Wales, Australia, and 18 completed the study. All received the study intervention of four text messages per week for six months. Questionnaires addressing the self-reported outcome measures were performed at the start and completion of the study. Forty percent of participants lost weight and 40% of smokers decreased their cigarette intake over the study. Sixty percent reported an overall improved health score. Over 80% of patients found the programme effective for themselves, and all recommended that it be made available to other patients. The cost was A$1.20 per patient per month. Our study showed improvement in some of the risk factors for perioperative morbidity and mortality. With improved methods to increase enrolment, our overall impression is that text message–based mobile health prehabilitation may be a feasible, cost-effective and worthwhile intervention for patients with obesity.

scholarly journals Risk factors for domestic infestation by the Chagas disease vector, Triatoma dimidiata in Chiquimula, Guatemala

2013 ◽  
Vol 103 (6) ◽  
pp. 634-643 ◽  
Author(s):  
E. N. I. Weeks ◽  
C. Cordón-Rosales ◽  
C. Davies ◽  
S. Gezan ◽  
M. Yeo ◽  
...  
Keyword(s):  
Risk Factors ◽  
Chagas Disease ◽  
Current Method ◽  
Cost Effective ◽  
Subsequent Treatment ◽  
Disease Vector ◽  
Surrounding Environment ◽  
Increased Risk ◽  
High Level ◽  
House Infestation

AbstractIn Guatemala prior to control initiatives, the main vectors of Trypanosoma cruzi, the causative agent of Chagas disease, were Rhodnius prolixus and Triatoma dimidiata. This study conducted in 2006 in the department of Chiquimula recorded a high level of T. dimidiata infestation and an absence of R. prolixus in all surveyed communities. In Guatemala, the presence of T. dimidiata as domestic, peridomestic and sylvatic populations results in control difficulties as houses are re-infested from the surrounding environment. Entomological surveys, the current method used to select houses in need of control efforts, are labour intensive and time consuming. A time- and cost-effective way to prioritize houses for evaluation and subsequent treatment is the stratification of houses based on the risk of triatomine infestation. In the present study, 17 anthropogenic risk factors were evaluated for associations with house infestation of T. dimidiata including: wall, floor and roof type. There was an increased likelihood of domestic infestation with T. dimidiata associated with the presence of dirt floors (18/29; OR 8.075, 95% CI 2.13–30.6), uncoated bajareque walls (12/17; OR 4.80, 95% CI 1.35–17.1) and triatomine-like faeces on walls (16/26; OR 3.89, 95% CI 1.19–12.7). These factors could be used to target control of T. dimidiata to communities with an increased risk of being infested.

scholarly journals Epidemiological correlates with communicable viral co-infections of hepatitis B and hepatitis C and non-communicable diabetes among HIV ART naïve rural patients of Kanchipuram district: a prospective cohort study

2018 ◽  
Vol 5 (8) ◽  
pp. 3283
Author(s):  
A. Kasthuri ◽  
K. Mohana Krishnan ◽  
S. K. Amsavathani
Keyword(s):  
Risk Factors ◽  
Cohort Study ◽  
Hepatitis C ◽  
Hepatitis B ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Diabetic Patients ◽  
Increased Risk ◽  
Significant Difference ◽  
Onset Of Diabetes

Background: The objectives of the study were to study the epidemiological correlates of ART Naïve HIV cases; to study the incidence of co–infections among them; to find the incidence of onset of diabetes among them. Concomitant infection of hepatitis B virus, hepatitis C virus viruses leads to higher frequency of carrier state and severe manifestations of the disease in HIV patients. There is general agreement that the traditional risk factors for DM (increasing age, minority race, obesity) are still responsible for most of the increased risk in the HIV infected population.Methods: This study was designed as a prospective cohort study and was done at the Meenakshi Medical College & Research institute, an academic and Tertiary medical centre in Kanchipuram, Tamil Nadu, South India. The study duration was from June 2004 to June 2010. SPSS 13 was used in the calculation of chi-square and percentages.Results: Among 207 participants, mean age is 36.04 and the SD is 10.895. There is significant difference between the incidence of viral co-infections like hepatitis B and hepatitis C (p<0.001). There is significant difference between the incidence of onset of diabetes (p<0.001). The HbsAg and HCV co infection was comparatively lower than the urban population. Among the 50 HIV reactive, non diabetic patients without risk factors, only one found to be Diabetic and another found to be Pre diabetic after 6 months follow-up.Conclusions: The cost of treatment escalates, when PLHA is co-infected either with viral infections or diabetes, and also their quality of life becomes poor. So, monitoring of CD4 and CD8 should be done as a routine and screening and early treatment should be made mandatory. 

scholarly journals A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes: the Anglo–Danish–Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION-Europe) study

2016 ◽  
Vol 20 (64) ◽  
pp. 1-86 ◽  
Author(s):  
Rebecca K Simmons ◽  
Knut Borch-Johnsen ◽  
Torsten Lauritzen ◽  
Guy EHM Rutten ◽  
Annelli Sandbæk ◽  
...  
Keyword(s):  
Risk Factors ◽  
Patient Reported Outcomes ◽  
Cost Effective ◽  
Well Being ◽  
Health Technology ◽  
Patient Reported ◽  
All Cause Mortality

BackgroundIntensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain.ObjectiveTo quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes.DesignPragmatic, multicentre, cluster-randomised, parallel-group trial.SettingThree hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK.ParticipantsIndividuals aged 40–69 years with screen-detected diabetes.InterventionsScreening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol.Main outcome measuresThe primary end point was a composite of first cardiovascular event (cardiovascular mortality/morbidity, revascularisation and non-traumatic amputation) during a mean [standard deviation (SD)] follow-up of 5.3 (1.6) years. Secondary end points were (1) all-cause mortality; (2) microvascular outcomes (kidney function, retinopathy and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective Diabetes Study outcomes model [version 1.3;©Isis Innovation Ltd 2010; seewww.dtu.ox.ac.uk/outcomesmodel(accessed 27 January 2016)].ResultsWe included 3055 (RC,n = 1377; IT,n = 1678) of the 3057 recruited patients [mean (SD) age 60.3 (6.9) years] in intention-to-treat analyses. Prescription of glucose-lowering, antihypertensive and lipid-lowering medication increased in both groups, more so in the IT group than in the RC group. There were clinically important improvements in cardiovascular risk factors in both study groups. Modest but statistically significant differences between groups in reduction in glycated haemoglobin (HbA1c) levels, blood pressure and cholesterol favoured the IT group. The incidence of first cardiovascular event [IT 7.2%, 13.5 per 1000 person-years; RC 8.5%, 15.9 per 1000 person-years; hazard ratio 0.83, 95% confidence interval (CI) 0.65 to 1.05] and all-cause mortality (IT 6.2%, 11.6 per 1000 person-years; RC 6.7%, 12.5 per 1000 person-years; hazard ratio 0.91, 95% CI 0.69 to 1.21) did not differ between groups. At 5 years, albuminuria was present in 22.7% and 24.4% of participants in the IT and RC groups, respectively [odds ratio (OR) 0.87, 95% CI 0.72 to 1.07), retinopathy in 10.2% and 12.1%, respectively (OR 0.84, 95% CI 0.64 to 1.10), and neuropathy in 4.9% and 5.9% (OR 0.95, 95% CI 0.68 to 1.34), respectively. The estimated glomerular filtration rate increased between baseline and follow-up in both groups (IT 4.31 ml/minute; RC 6.44 ml/minute). Health status, well-being, diabetes-specific quality of life and treatment satisfaction did not differ between the groups. The intervention cost £981 per patient and was not cost-effective at costs ≥ £631 per patient.ConclusionsCompared with RC, IT was associated with modest increases in prescribed treatment, reduced levels of risk factors and non-significant reductions in cardiovascular events, microvascular complications and death over 5 years. IT did not adversely affect patient-reported outcomes. IT was not cost-effective but might be if delivered at a reduced cost. The lower than expected event rate, heterogeneity of intervention delivery between centres and improvements in general practice diabetes care limited the achievable differences in treatment between groups. Further follow-up to assess the legacy effects of early IT is warranted.Trial registrationClinicalTrials.gov NCT00237549.Funding detailsThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 64. See the NIHR Journals Library website for further project information.

scholarly journals Comparison of Patient-Reported Outcomes at 1 Year After Injury Between Limb Salvage and Amputation: A Prospective Cohort Study

2021 ◽  
Author(s):  
Taketo Kurozumi ◽  
Takahiro Inui ◽  
Yuhei Nakayama ◽  
Akifumi Honda ◽  
Kentaro Matsui ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Cohort Study ◽  
Limb Salvage ◽  
Lower Limb ◽  
Prospective Cohort ◽  
Patient Reported Outcomes ◽  
Early Recovery ◽  
Patient Reported

Abstract Background: Owing to advances in knowledge and technology, salvaging the limbs of patients with severe trauma and injuries is possible. However, severe limb injuries occasionally necessitate amputation because it allows patients to regain their social lives earlier than limb salvaging. Moreover, previous related investigations are retrospective cohort studies or meta-analyses of retrospective studies, and prospective cohort studies of patient-reported outcomes are extremely rare. This single-center, prospective cohort study aimed to compare the patient-reported outcomes at 1 year after injury between limb salvage and amputation and to elucidate whether amputation contributes to early recovery of functionality and quality of life.Methods: We included 47 limbs of 45 patients with severe open fractures of the lower limb and categorized them into limb salvage and amputation groups. They were registered in the Database of Orthopedic Trauma by the Japanese Society for Fracture Repair at our center; data on patient-reported outcomes at 1 year after injury were obtained from this database. The mean patient age was 49.6 years. Patients’ limbs were evaluated using the lower extremity functional scale (LEFS) and Short-Form 8 (SF-8). Early recovery was evaluated using functionality and quality-of-life questionnaires. Nonparametric statistical analyses were conducted.Results: Of the 47 limbs, 34 limbs of 34 patients were salvaged and 13 limbs of 11 patients were amputated. Significant differences were noted between the limb salvage and amputation groups in terms of the LEFS scores (mean: 49.5 vs 33.1, P=0.025) and scores for the mental health component (mean: 48.7 vs 38.7, P=0.003), role–physical component (mean: 42.2 vs 33.3, P=0.026), and mental component summary (mean: 48.2 vs 41.3, P=0.042) of the SF-8. The limb salvage group had better scores than the amputation group. Conclusions: In this study, limb salvage results in better functional and mental health outcomes at 1 year after severe lower limb injury than after amputation. As reconstruction technology has advanced and limb salvaging has become possible, the focus of studies should now be based on the perspective of “how the patient feels”; hence, we believe that the results of this study, which is based on patient-reported outcomes, are meaningful.

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