Trainees' perspectives on sickle cell education: a qualitative needs assessment.

BACKGROUND: Sickle cell disease (SCD) exemplifies many of the social, racial, and healthcare equity issues in the United States. Despite its high morbidity, mortality, and cost of care, SCD has not been prioritized in research and clinical teaching, resulting in under-trained clinicians and a poor evidence base for managing complications of the disease. This study aimed to perform a needs assessment, examining the perspectives of medical trainees pursuing hematology/oncology subspecialty training regarding SCD-focused education and clinical care. METHOD: Inductive, iterative thematic analysis was used to explore qualitative interviews of subspecialty hematology-oncology trainees' attitudes and preferences for education on the management of patients with SCD. Fifteen trainees from six programs in the United States participated in 4 focus groups between April and May 2023. RESULTS: Thematic analysis resulted in 3 themes: 1. Discomfort caring for patients with SCD. 2. Challenges managing complications of SCD, and 3. Desire for SCD specific education. Patient care challenges included the complexity of managing SCD complications, limited evidence to guide practice, and healthcare bias. Skill-building challenges included lack of longitudinal exposure, access to expert clinicians, and didactics. CONCLUSIONS: Variations in exposure, limited formal didactics, and a lack of national standardization for SCD education during training contributes to trainees' discomfort and challenges in managing SCD, which in turn, contribute to decreased interest in entering the SCD workforce. The findings underscore the need for ACGME competency amendments, dedicated SCD rotations, and standardized didactics to address the gaps in SCD education.

An Observational Study of Proactive and On-Request Psychiatry Consultation Services: Evidence for Differing Roles and Outcomes.

BACKGROUND: Proactive psychiatric consultation services rapidly identify and assess medical inpatients in need of psychiatric care. In addition to more rapid contact, proactive services may reduce the length of stay and improve staff satisfaction. However, in some settings, it is impractical to integrate a proactive consultation service into every hospital unit; on-request and proactive services are likely to coexist in the future. Prior research has focused on changes in outcomes with the implementation of proactive services. OBJECTIVE AND METHODS: This report describes differences between contemporary proactive and on-request services within the same academic medical center, comparing demographic and clinical data collected retrospectively from a 4-year period from the electronic medical record. RESULTS: The proactive service saw patients over four times as many initial admissions (7592 vs. 1762), but transitions and handoffs between services were common, with 434 admissions involving both services, comprising nearly 20% of the on-request service's total contacts. The proactive service admissions had a shorter length of stay and a faster time to first psychiatric contact, and the patients seen were more likely to be female, of Black race, and to be publicly insured. There were over three times as many admissions to psychiatry from the proactive service. The on-request service's admissions had a longer length of stay, were much more likely to involve intensive care unit services, surgical services, and transfers among units, and the patients seen were more likely to die in the hospital or to be discharged to subacute rehabilitation. CONCLUSIONS: Overall, the results suggest that the two services fulfill complementary roles, with the proactive service's rapid screening and contact providing care to a high volume of patients who might otherwise be unidentified and underserved. Simultaneously, the on-request service's ability to manage patients in response to consult requests over a much larger area of the hospital provided important support and continuity for patients with complex health needs. Institutions revising their consultation services will likely need to consider the best balance of these differing functions to address perceived demand for services.

Predictors of acute care utilization and acute pain treatment outcomes in adults with sickle cell disease: The role of non-hematologic characteristics and baseline chronic opioid dose.

Despite its rarity in the United States, sickle cell disease accounts for a disproportionate amount of healthcare utilization and costs. The majority of this is due to acute care for painful crises. A small subpopulation of patients accounts for most these costs due to frequent visits to emergency departments and acute care facilities. Previous investigations have found that these high utilizing patients are distinguished by both a more severe disease course and certain non-hematologic characteristics, which may include higher socioeconomic status and some psychiatric and psychological characteristics. This prospective observational cohort study was undertaken to test the ability of these characteristics to prospectively predict acute pain care outcomes, including visit frequency, total opioid doses, and pain improvement at the Johns Hopkins Sickle Cell Infusion Center (SCIC). Seventy-three participants were followed for 12 months and SCIC utilization and treatment outcomes were tabulated for 378 visits. Participants who visited the SCIC most frequently had markedly worse pain improvement despite higher within-visit opioid doses. Higher utilization was associated with indicators of greater illness severity, more aggressive treatment for sickle cell disease, higher baseline opioid doses, higher socioeconomic status, greater pain-related anxiety, and a history of psychiatric treatment. Overall, poor acute pain treatment response was associated with higher utilization and higher baseline opioid doses. The pattern of association between high utilization, poor acute care outcomes, and higher baseline opioid doses is discussed in terms of prior research and future directions.

Impact of a dedicated infusion clinic for acute management of adults with sickle cell pain crisis.

Most adults with sickle cell disease (SCD) receive care for their acute painful episodes in an emergency department (ED) setting. The purpose of this article is to describe the impact of opening a dedicated treatment center for adults with SCD [Sickle Cell Infusion Clinic (SCIC)] on patient outcomes and on hospital discharges for SCD. Descriptive data including demographics, time to first dose of narcotic, and pain scores were collected on patients presenting to the SCIC and ED. Maryland hospital discharge data were obtained from the Maryland Health Services Cost Review Commission. Analyses were conducted using T tests, χ(2) tests, and simple generalized estimating equation regression models accounting for the clustered nature of observations, as appropriate. There were 3,874 visits to the SCIC by 361 unique patients; 85% of those visits resulted in the patient being sent home. During the same time period, there were 3,408 visits to the ED by 558 unique patients with SCD. The overall admission rate from the ED for these patients was 35.9% but decreased significantly over the time period with a rate of 20% in December 2011. There was a significant decrease in readmissions over time for the entire Baltimore Metro area with the likelihood of readmission decreasing by 7% over time. The SCIC model provides adults with SCD access to high quality care that decreases the need for hospital admission. Further research needs to be done to evaluate the cost effectiveness of this model.

Systematic review, network meta-analysis and exploratory cost-effectiveness model of randomized trials of minimally invasive techniques versus surgery for varicose veins.

BACKGROUND: A Health Technology Assessment was conducted to evaluate the relative clinical effectiveness and cost-effectiveness of minimally invasive techniques (foam sclerotherapy (FS), endovenous laser ablation (EVLA) and radiofrequency ablation (RFA)) for managing varicose veins, in comparison with traditional surgery. METHODS: A systematic review of randomized clinical trials (RCTs) was undertaken to assess the effectiveness of minimally invasive techniques compared with other treatments, principally surgical stripping, in terms of recurrence of varicose veins, Venous Clinical Severity Score (VCSS), pain and quality of life. Network meta-analysis and exploratory cost-effectiveness modelling were performed. RESULTS: The literature search conducted in July 2011 identified 1453 unique citations: 31 RCTs (51 papers) satisfied the criteria for effectiveness review. Differences between treatments were negligible in terms of clinical outcomes, so the treatment with the lowest cost appears to be most cost-effective. Total FS costs were estimated to be lowest, and FS was marginally more effective than surgery. However, relative effectiveness was sensitive to the model time horizon. Threshold analysis indicated that EVLA and RFA might be considered cost-effective if their costs were similar to those for surgery. These findings are subject to various uncertainties, including the risk of bias present in the evidence base and variation in reported costs. CONCLUSION: This assessment of currently available evidence suggests there is little to choose between surgery and the minimally invasive techniques in terms of efficacy or safety, so the relative cost of the treatments becomes one of the deciding factors. High-quality RCT evidence is needed to verify and further inform these findings.

Colistimethate sodium powder and tobramycin powder for inhalation for the treatment of chronic Pseudomonas aeruginosa lung infection in cystic fibrosis: systematic review and economic model.

BACKGROUND: Cystic fibrosis (CF) is an inherited condition characterised by the abnormal transport of chloride ions across transporting epithelia. This leads to the production of thick sticky mucus in the lungs, pancreas, liver, intestine and reproductive tract, and an increase in the salt content in sweat. Among other problems, people with CF experience recurrent respiratory infections and have difficulties digesting food. CF affects over 9000 individuals in the UK. CF shortens life expectancy and adversely affects quality of life. In 2010, CF was recorded as the cause of 103 deaths in England and Wales. OBJECTIVE: To evaluate the clinical effectiveness and cost-effectiveness of colistimethate sodium dry powder for inhalation (DPI) (Colobreathe(®), Forest Laboratories) and tobramycin DPI (TOBI Podhaler(®), Novartis Pharmaceuticals) for the treatment of Pseudomonas aeruginosa lung infection in CF. DATA SOURCES: Electronic databases were searched in February and March 2011 [MEDLINE, MEDLINE In-Process & Other Non-Indexed citations, EMBASE, The Cochrane Library databases, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Web of Science, Conference Proceedings Citation Index (CPCI) and Bioscience Information Service (BIOSIS) Previews]. Relevant databases were searched for ongoing and unpublished studies, and bibliographies of relevant systematic reviews and the manufacturers' submissions were also hand-searched. REVIEW METHODS: A systematic review of the clinical effectiveness and cost-effectiveness of colistimethate sodium DPI and tobramycin DPI for the treatment of chronic P. aeruginosa lung infection in CF was conducted. Existing economic evidence within the literature was reviewed and a de novo health economic model was also developed. RESULTS: Three randomised controlled trials (RCTs) were included in the clinical effectiveness review. Both colistimethate sodium DPI and tobramycin DPI were reported to be non-inferior to nebulised tobramycin for the outcome forced expiratory volume in first second percentage predicted (FEV1%). It was not possible to draw any firm conclusions as to the relative efficacy of colistimethate sodium DPI compared with tobramycin DPI. The economic analysis suggests that colistimethate sodium DPI produces fewer quality-adjusted life-years (QALYs) than nebulised tobramycin. Given the incremental discounted lifetime cost of tobramycin DPI compared with nebulised tobramycin, it highly unlikely that tobramycin DPI has an incremental cost-effectiveness ratio that is better than £30,000 per QALY gained. LIMITATION: The uncertainty surrounding the short-term evidence base inevitably results in uncertainty surrounding the long-term clinical effectiveness and cost-effectiveness of colistimethate sodium DPI. CONCLUSIONS: Both DPI formulations have been shown to be non-inferior to nebulised tobramycin as measured by FEV1%. The results of these trials should be interpreted with caution owing to the means by which the results were analysed, the length of follow-up, and concerns about the ability of FEV1% to accurately represent changes in lung health. Although the increase in QALYs is expected to be lower with colistimethate sodium DPI than with nebulised tobramycin, a price for this intervention had not been agreed at the time of the assessment. Depending on the price of colistimethate sodium DPI, this results either in a situation whereby colistimethate sodium DPI is dominated by nebulised tobramycin or in one whereby the incremental cost-effectiveness of nebulised tobramycin compared with colistimethate sodium DPI is in the range of £24,000-277,000 per QALY gained. The economic analysis also suggests that, given its price, it is unlikely that tobramycin DPI has a cost-effectiveness ratio of < £30,000 per QALY gained when compared with nebulised tobramycin. A RCT to assess the longer-term (≥ 12 months) efficacy of colistimethate sodium DPI and tobramycin DPI in comparison with nebulised treatments would be beneficial. Such a study should include the direct assessment of HRQoL using a relevant preference-based instrument. Future studies should ensure that the European Medicines Agency guidelines are adhered to. In addition, high-quality research concerning the relationship between forced expiratory volume in first second % (FEV1%) predicted or other measures of lung function and survival/health-related quality of life (HRQoL) would be useful. STUDY REGISTRATION: PROSPERO CRD42011001350. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Clinical effectiveness and cost-effectiveness of minimally invasive techniques to manage varicose veins: a systematic review and economic evaluation.

BACKGROUND: Varicose veins are enlarged, visibly lumpy knotted veins, usually in the legs. Uncomplicated varicose veins can cause major discomfort and some complications. They are part of chronic venous disease (CVD), which is reported to have a substantial negative impact on health-related quality of life (HRQoL). Traditional treatments for varicose veins involve surgical stripping and ligation and liquid sclerotherapy (LS), but can be invasive and painful. New minimally invasive treatments offer an alternative. These treatments typically involve use of laser, radiofrequency or foam sclerosant. They are increasingly widely used and offer potential benefits such as reduced complications, faster recovery, fewer physical limitations and improved quality of life. OBJECTIVE: The aim of this report is to evaluate the clinical effectiveness, safety and cost-effectiveness of the minimally invasive techniques of foam sclerotherapy (FS), endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in comparison with other techniques, including traditional surgical techniques, LS and conservative management, in the management of varicose veins. DATA SOURCES: A systematic search was made of 11 bibliographic databases of published and unpublished literature from their inception to July 2011: MEDLINE; EMBASE; Cumulative Index to Nursing and Allied Health Literature; The Cochrane Library; Biological Abstracts; Science Citation Index (SCI); Social Sciences Citation Index; Conference Proceedings Citation Index-Science; UK Clinical Research Network; Current Controlled Trials; and ClinicalTrials.gov. REVIEW METHODS: A systematic review of randomised controlled trials (RCTs) to assess the clinical effectiveness of minimally invasive techniques compared with other treatments, principally surgical stripping, in terms of recurrence of varicose veins, retreatment and clinical symptoms, as measured by the Venous Clinical Severity Score (VCSS), pain and quality of life. Network meta-analysis and exploratory cost-effectiveness modelling were performed. RESULTS: The literature search identified 1453 unique citations, of which 34 RCTs (54 papers) satisfied the criteria for the clinical effectiveness review. The minimally invasive techniques reported clinical outcomes similar to surgery. Rates of recurrence were slightly lower for EVLA, RFA and FS, especially for longer follow-up periods; VCSS score was lower for EVLA and FS than for stripping, but slightly higher for RFA; short-term pain was less for FS and RFA but higher for EVLA; higher quality-of-life scores were reported for all evaluated interventions than for stripping. Differences between treatments were therefore negligible in terms of clinical outcomes, so the treatment with the lowest cost appears to be most cost-effective. Our central estimate is that total FS costs were lowest and FS is marginally more effective than stripping. However, this result was sensitive to the model time horizon. Threshold analysis indicated that EVLA and RFA might be considered cost-effective if their costs are equivalent to stripping. These findings are subject to uncertainty on account of the risk of bias present in the evidence base and the variation in costs. LIMITATIONS: The relative clinical effectiveness and cost-effectiveness of the techniques are principally based on rates of post-operative technical recurrence rather than symptomatic recurrence, as this was the reported outcome in all trials. The true proportion of treated individuals who are likely to present with symptoms of recurrence requiring retreatment is therefore not certain. A figure reflecting the likely proportion of treated individuals who would experience symptomatic recurrence requiring retreatment (with its associated costs), therefore, had to be calculated by the authors based on a small number of studies. The findings of this report also need to be verified by data from future trials with longer follow-up and using more standardised outcome measures. CONCLUSIONS: This assessment of the currently available evidence suggests there is little to choose between the minimally invasive techniques in terms of efficacy or cost, and each offers a viable, clinically effective alternative to stripping. FS might offer the most cost-effective alternative to stripping, within certain time parameters. High-quality RCT evidence is needed. Future trials should aim to measure and report outcomes in a standardised manner, which would permit more efficient pooling of their results. STUDY REGISTRATION: PROSPERO number CRD42011001355. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

ICT reuse in socio-economic enterprises.

In Europe, socio-economic enterprises such as charities, voluntary organisations and not-for-profit companies are involved in the repair, refurbishment and reuse of various products. This paper characterises and analyses the operations of socio-economic enterprises that are involved in the reuse of Information and Communication Technology (ICT) equipment. Using findings from a survey, the paper specifically analyses the reuse activities of socio-economic enterprises in the U.K. from which Europe-wide conclusions are drawn. The amount of ICT products handled by the reuse organisations is quantified and potential barriers and opportunities to their operations are analysed. By-products from reuse activities are discussed and recommendations to improve reuse activities are provided. The most common ICT products dealt with by socio-economic enterprises are computers and related equipment. In the U.K. in 2010, an estimated 143,750 appliances were reused. However, due to limitations in data, it is difficult to compare this number to the amount of new appliances that entered the U.K. market or the amount of waste electrical and electronic equipment generated in the same period. Difficulties in marketing products and numerous legislative requirements are the most common barriers to reuse operations. Despite various constraints, it is clear that organisations involved in reuse of ICT could contribute significantly to resource efficiency and a circular economy. It is suggested that clustering of their operations into "reuse parks" would enhance both their profile and their products. Reuse parks would also improve consumer confidence in and subsequently sales of the products. Further, it is advocated that industrial networking opportunities for the exchange of by-products resulting from the organisations' activities should be investigated. The findings make two significant contributions to the current literature. One, they provide a detailed insight into the reuse operations of socio-economic enterprises. Previously unavailable data has been presented and analysed. Secondly, new evidence about the by-products/materials resulting from socio-economic enterprises' reuse activities has been obtained. These contributions add substantially to our understanding of the important role of reuse organisations.

Systematic review, meta-analysis and economic modelling of diagnostic strategies for suspected acute coronary syndrome.

BACKGROUND: Current practice for suspected acute coronary syndrome (ACS) involves troponin testing 10-12 hours after symptom onset to diagnose myocardial infarction (MI). Patients with a negative troponin can be investigated further with computed tomographic coronary angiography (CTCA) or exercise electrocardiography (ECG). OBJECTIVES: We aimed to estimate the diagnostic accuracy of early biomarkers for MI, the prognostic accuracy of biomarkers for major adverse cardiac adverse events (MACEs) in troponin-negative patients, the diagnostic accuracy of CTCA and exercise ECG for coronary artery disease (CAD) and the prognostic accuracy of CTCA and exercise ECG for MACEs in patients with suspected ACS. We then aimed to estimate the cost-effectiveness of using alternative biomarker strategies to diagnose MI, and using biomarkers, CTCA and exercise ECG to risk-stratify troponin-negative patients. DATA SOURCES: We searched MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations; Cumulative Index of Nursing and Allied Health Literature (CINAHL), EMBASE, Web of Science, Cochrane Central Database of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR), NHS Database of Abstracts of Reviews of Effects (DARE) and the Health Technology Assessment database from 1985 (CTCA review) or 1995 (biomarkers review) to November 2010, reviewed citation lists and contacted experts to identify relevant studies. REVIEW METHODS: Diagnostic studies were assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) tool and prognostic studies using a framework adapted for the project. Meta-analysis was conducted using bayesian Markov chain Monte Carlo simulation. We developed a decision-analysis model to evaluate the cost-effectiveness of alternative biomarker strategies to diagnose MI, and the cost-effectiveness of biomarkers, CTCA or exercise ECG to risk-stratify patients with a negative troponin. Strategies were applied to a theoretical cohort of patients with suspected ACS. Cost-effectiveness was estimated as the incremental cost per quality-adjusted life-year (QALY) of each strategy compared with the next most effective, taking a health-service perspective and a lifetime horizon. RESULTS: Sensitivity and specificity (95% predictive interval) were 77% (29-96%) and 93% (46-100%) for troponin I, 80% (33-97%) and 91% (53-99%) for troponin T (99th percentile threshold), 81% (50-95%) and 80% (26-98%) for quantitative heart-type fatty acid-binding protein (H-FABP), 68% (11-97%) and 92% (20-100%) for qualitative H-FABP, 77% (19-98%) and 39% (2-95%) for ischaemia-modified albumin and 62% (35-83%) and 83% (35-98%) for myoglobin. CTCA had 94% (61-99%) sensitivity and 87% (16-100%) specificity for CAD. Positive CTCA and positive-exercise ECG had relative risks of 5.8 (0.6-24.5) and 8.0 (2.3-22.7) for MACEs. In most scenarios in the economic analysis presentation, high-sensitivity troponin measurement was the most effective strategy with an incremental cost-effectiveness ratio (ICER) of less than the £20,000-30,000/QALY threshold (ICER £7487-17,191/QALY). CTCA appeared to be the most cost-effective strategy for patients with a negative troponin, with an ICER of £11,041/QALY. However, when a lower MACE rate was assumed, CTCA had a high ICER (£262,061/QALY) and the no-testing strategy was optimal. LIMITATIONS: There was substantial variation between the primary studies and heterogeneity in their results. Findings of the economic model were dependent on assumptions regarding the value of detecting and treating positive cases. CONCLUSIONS: Although presentation troponin has suboptimal sensitivity, measurement of a 10-hour troponin level is unlikely to be cost-effective in most scenarios compared with a high-sensitivity presentation troponin. CTCA may be a cost-effective strategy for troponin-negative patients, but further research is required to estimate the effect of CTCA on event rates and health-care costs. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Direct costs and survival of medicare beneficiaries with early and advanced Parkinson's disease.

BACKGROUND: No recent analysis details Parkinson's Disease (PD) costs or survival for Medicare beneficiaries. This study assesses excess direct costs and survival in Medicare beneficiaries with early and advanced PD. METHODS: Patients with ≥ 2 PD diagnoses (ICD-9-CM: 332.0), ≥ age 65, continuously enrolled in Parts A&B during one-year baseline and study periods were selected from the Medicare 5% sample (N = 3.2 million, 1999-2008). Newly diagnosed patients were defined as having no baseline claims for movement disorder, dementia, Alzheimer's, bipolar disorder, psychosis, falls or related injuries, ambulatory assistance device (walker or wheelchair), or skilled nursing facility. Controls without PD were demographically matched 1:1. Costs to Medicare were compared via Wilcoxon rank-sum tests and inverse probability weighted multivariate regression. Survival was assessed via Cox proportional hazards analysis. RESULTS: Costs in the year post-diagnosis were higher for newly diagnosed patients (N = 9,201, $7423) than controls ($5024), resulting in excess PD-associated costs of $2399 (p < 0.001). Cumulative excess costs were $28,422 from the year prior to index quarter to five years following (p < 0.01). PD patients receiving their first claim for an ambulatory assistance device (N = 11,294) had excess cumulative costs of $50,923 (p < 0.001) over the same period; those receiving their first claim for a skilled nursing facility (N = 10,152) had excess costs of $102,750 (p < 0.001). Hazard rates of mortality were higher among newly diagnosed PD (1.43, p < 0.001), ambulatory assistance device (2.37, p < 0.001) and skilled nursing facility (3.34, p < 0.001) cohorts than in corresponding non-PD groups. CONCLUSIONS: Medicare beneficiaries with PD have substantially and progressively higher costs and mortality compared with controls.

Reasons for the use and non-use of school sexual health services: a systematic review of young people's views.

BACKGROUND: The potential for sexual health services to influence the sexual health and behaviour of school-aged young people is only likely to be realised if these services are accessed. This review and synthesis seeks to explore children and adolescents' views and experiences of school-based and school-linked sexual health services to identify barriers to and facilitators of service use. METHODS: The study design is a systematic review of studies focusing on the views of children and adolescents (11-18 years) about relevant services. Sixteen databases were searched, titles and abstracts were screened against the inclusion criteria, data extraction and quality assessment of included studies were performed and thematic synthesis was undertaken. RESULTS: Nineteen relevant studies were identified, but only studies from the USA and the UK satisfied the inclusion criteria. The principal themes to emerge from the analysis were awareness and need, confidentiality and disclosure, perceptions of staff, service location, physical environment, costs and types of services on offer. These findings were consistent across country and type of service. CONCLUSIONS: In the view of young people, school-linked sexual health services need to guarantee and promote the ideas of privacy, confidentiality and approachability if they are to be accessed and have an impact on behaviour.

Hemiarthroplasty and total hip arthroplasty for treating primary intracapsular fracture of the hip: a systematic review and cost-effectiveness analysis.

BACKGROUND: Hip fracture is a common problem in people aged > 60 years. The treatment options for individuals with high pre-fracture mobility, function and independence are hemiarthroplasty (HA) and total hip arthroplasty (THA). OBJECTIVE: The aim of this report is to assess the clinical effectiveness and cost-effectiveness evidence of THA compared with HA in patients with displaced intracapsular fracture who are cognitively intact with high pre-fracture mobility or function. DATA SOURCES: A systematic search was made of 11 databases of published and unpublished literature from their inception to december 2010: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library, Biological Science Citation Index, Social Science Citation Index, Conference Proceedings Citation Index - Science, UK Clinical Trials Research Network and the National Research Register archive, Current Controlled Trials and ClinicalTrials.gov. REVIEW METHODS: A systematic review of randomised controlled trials (RCTs) to assess the effectiveness of THA compared with HA in terms of dislocations, revisions, pain and function, and quality of life. Meta-analysis, independent subgroup analyses and exploratory cost-effectiveness modelling were performed. RESULTS: The literature search identified 532 unique citations, of which eight RCTs with almost 1000 participants satisfied the criteria for the effectiveness review. Meta-analysis found a statistically significant increased risk of dislocation for patients treated with THA compared with HA (p = 0.01), but a reduced risk of revision (p = 0.0003). There were no differences in terms of mortality. In all trials, individuals treated with THA reported better function and mobility and less pain than those treated with HA. Four trials reporting utility data found similar trends. Sensitivity analyses indicated that there were no statistically significant differences in outcomes based on follow-up, study quality, surgical approach taken, type of head or the use of cement. Four papers reported a cost-utility analysis or the cost-effectiveness of THA compared with HA. Exploratory modelling was undertaken that showed that THA is likely to be cost-effective compared with HA even when the limitations of the data and methodology are considered. LIMITATIONS: The costs and disutilities associated with revisions and dislocations were not included in the economic evaluation. CONCLUSIONS: THA appears to be more cost-effective than HA. It is likely that THA will be associated with increased costs in the initial 2-year period, but lower longer-term costs, owing to potentially lower revision rates. However, these longer-term costs have not been modelled. The capacity and experience of surgeons to perform THA have not been explored and these would need to be addressed at local level were THA to become recommended for active, elderly patients in whom THA is not contraindicated. Further studies examining the impact of surgeon experience on performing the two procedures may offer more robust evidence on outcomes. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Evidence Review Group approaches to the critical appraisal of manufacturer submissions for the NICE STA process: a mapping study and thematic analysis.

BACKGROUND: The National Institute for Health and Clinical Excellence (NICE) single technology appraisal (STA) process was set up as a rapid way to appraise new technologies for use within the NHS in England and Wales and has been in place since 2005. OBJECTIVES: This study had five primary objectives: (1) to provide a map of the STA process to date; (2) to identify current approaches to the critical appraisal of manufacturers' submissions (MSs) by Evidence Review Groups (ERGs); (3) to identify recurring themes in clarification letters sent to manufacturers; (4) to provide recommendations for possible alternative approaches to be used in the critical appraisal process; and (5) to revise the current ERG report template. DATA SOURCES: Data for the mapping of the STA process were obtained from the NICE website (www.nice.org.uk). Data for the analyses of the ERG reports and clarification letters were taken from the reports and letters themselves. REVIEW METHODS: For the mapping, a spreadsheet was developed to collect data on 22 predefined variables related to timings and outcomes. Simple descriptive statistics were used to analyse the data. For the thematic analysis, a documentary analysis of 30 ERG reports was undertaken. Data on key elements of the MSs, the processes undertaken by ERGs and the strengths and weaknesses of MSs were extracted. A framework of a priori themes was developed. Data were extracted, coded and analysed according to a framework approach. Twenty-one clarification letters were examined and data were extracted using a set of codes to cover report quality, systematic review methods and clinical/economic issues. The current ERG report template was modified and sent to the current ERG teams for comment. All comments were considered and formed the basis for further revisions to the template. RESULTS: Ninety-five STAs were included in the mapping exercise. Many STAs were subject to delay or cancellation for a variety of reasons. The ERG reports highlighted the strengths and weaknesses of MSs to the STA process. Thematic analysis of these data offered a means of clarifying and describing these aspects of the submissions. This analysis generated five themes: process, reporting, satisfaction of objectives, reliability and validity of findings, and content. Points from clarification letters were analysed and presented in four main categories: report quality, systematic review methods, clinical data analysis and economic data analysis. LIMITATIONS: Nearly all data were obtained from the NICE website; therefore, any errors in the data on the website will be reflected in the mapping analysis presented in this report. Missing data for the mapping exercise limit the generalisability of the findings. Analyses were limited to what was reported in the ERG reports and the clarification letters. CONCLUSIONS: Guidance suggested for manufacturers will help to ensure that more appropriate submissions are received in the future while recommendations provided for ERG teams will help to guide teams to ensure that reporting methods are transparent. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

The clinical effectiveness and safety of prophylactic retinal interventions to reduce the risk of retinal detachment and subsequent vision loss in adults and children with Stickler syndrome: a systematic review.

BACKGROUND: Stickler syndrome, also known as hereditary progressive arthro-ophthalmopathy, is an inherited progressive disorder of the collagen connective tissues. Manifestations include short-sightedness, cataracts, retinal problems leading to retinal detachment and possible blindness. This is principally the case among individuals with type 1 Stickler Syndrome. It is the most commonly identified inherited cause of retinal detachment in childhood. However, there is no consensus regarding best practice and no current guidelines on prophylactic interventions for this population. OBJECTIVES: The aim of this systematic review was to assess the evidence for the clinical effectiveness and safety of primary prophylactic interventions for the prevention of retinal detachment in previously untreated eyes without retinal detachment in patients with Stickler syndrome. The primary outcome of interest was retinal detachment post prophylaxis. DATA SOURCES: A systematic search was made of 11 databases of published and unpublished literature, which included MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing and Allied Health Literature and The Cochrane Library. There was no restriction by language or date. The references of all included studies were checked for further relevant citations and authors of studies with potentially relevant data were also contacted. REVIEW METHODS: Two reviewers double-screened all titles and abstracts of the citations retrieved by the search to identify studies that satisfied the inclusion criteria. Both reviewers also independently extracted and quality assessed all included studies. A narrative synthesis was performed. RESULTS: The literature search identified 1444 unique citations, of which four studies satisfied the inclusion criteria. The two principal studies were both retrospective cohort studies with control groups in populations with type 1 Stickler syndrome. One study evaluated 360° cryotherapy (n = 204) and the other focal or circumferential laser treatment (n = 22). Both studies reported a statistically significant difference in the rate of retinal detachment per eye between the groups receiving prophylaxis and the controls. However, both studies were subject to a high risk of bias. The results of the two supporting studies of Wagner-Stickler patients were either relatively inconsistent or unreliable. No study reported any major or long-term complications associated with the interventions. Despite the weaknesses of the evidence, the rate of retinal detachment in the intervention groups, especially the cryotherapy group, was lower than the rate either experienced in the study control groups or reported in other studies of untreated Stickler syndrome populations not exposed to prophylaxis. CONCLUSIONS: Only 360° cryotherapy and focal and circumferential laser treatment have been evaluated for the type 1 Stickler syndrome population, and then only by a single retrospective, controlled, cohort study in each case. Both of these studies report a significant difference between intervention and control groups (principally no treatment) and no major or long-term side effects or complications. However, there is a high risk of bias within these two studies, so the relative effectiveness of either intervention is uncertain. FUTURE WORK: A service priority is to determine reliably the prevalence of Stickler syndrome, i.e. how many individuals have type 1 or type 2 Stickler syndrome, and their risk of retinal detachment and subsequent blindness. A non-randomised, prospective cohort comparison study, in which eligible participants are treated, followed-up and analysed in one of three study arms, for no treatment, laser therapy or cryotherapy, would potentially offer further certainty in terms of the relative efficacy of both prophylaxis versus no prophylaxis and cryotherapy versus laser therapy than is possible with the currently available data. Alternatively, continued follow-up and analysis of existing study data, and data collection from relevant sample populations, are required to assess the long-term risks of blindness, retinal detachment and prophylaxis. FUNDING: This study was funded by the National Institute for Health Research Health Technology Assessment programme.

Systematic review of the links between human resource management practices and performance.

BACKGROUND: In recent years human resource management (HRM) has been seen as an important factor in the successful realisation of organisational change programmes. The UK NHS is undergoing substantial organisational change and there is a need to establish which human resource (HR) initiatives may be most effective. OBJECTIVES: To assess the results from a wide-ranging series of systematic reviews of the evidence on HRM and performance. The first part assesses evidence on use of HRM in the UK and fidelity of practice implemented. The second part considers evidence for the impact of HRM practices on intermediate outcomes, which can impact on final outcomes, such as organisational performance or patient care. DATA SOURCES: The following databases were searched: Applied Social Sciences Index and Abstracts (ASSIA), British Nursing Index (BNI), Business Source Premier, Campbell Collaboration, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews (CDSR), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Database of Abstracts of Reviews of Effectiveness (DARE), DH-Data, EMBASE, Health Management Information Consortium (HMIC), International Bibliography of the Social Sciences (IBSS), King's Fund database, MEDLINE, NHS Economic Evaluation Database (NHS EED), National Research Register (NRR), PREMEDLINE, PsycINFO, ReFeR, Social Sciences Citation Index (SSCI) and Science Citation Index (SCI). The searches were conducted in May/June 2006. REVIEW METHODS: Broad categories of HRM interventions and intermediate outcomes were generated: 10 HRM categories and 12 intermediate outcome categories. Seven patient final outcomes were derived from the NHS Performance Indicators and the NHS Improvement Plan. The quality criteria used to select papers incorporated a longitudinal study design filter to provide evidence of the causal direction of relationships between HRM and relevant outcomes. Single HRM practices were considered. Within the health-specific literature, focus was on the impact of HRM on patient outcomes. Information is presented on the reliability of measures in each of the intermediate outcome areas. RESULTS: Work design practices that enhance employee autonomy and control influenced a number of outcomes and there was consistent evidence for the positive impact of increased job control on employee outcomes, such as job satisfaction, absence and health. For employee participation, the small number of studies reviewed supported the involvement of employees in design/implementation of changes that affect their work. In health literature in particular, employee involvement through quality improvement teams resulted in improved patient outcomes. Findings were positive for the impact of training on the intended outcomes of the initiatives. Support for the impact of performance management practices was apparent, in particular feedback on performance outcomes and the use of participative goal setting. Strong associations were found among all intermediate outcomes, and the relationship between most intermediate behaviours and outcomes were significant. LIMITATIONS: Limited evidence was available on the use of HRM and on the implementation of policy. Also, the specific practices studied within each HRM category differ so there was little evidence to show whether similar practices have the same effects in health and non-health settings. CONCLUSIONS: Some potentially effective practices for both health and non-health areas were identified, and HRM methods could be used to support change processes within the NHS; the findings relating to work organisation are particularly promising with regard to changes in methods of service delivery. Using training to support the implementation of change is highlighted. However, future multilevel studies that embrace the individual, team and organisational level are needed. Studies should look into interventions aimed at improving HR outcomes and performance, and allow for pre- and post-intervention measurement of practices and outcomes.

The burden of emergency department use for sickle-cell disease: an analysis of the national emergency department sample database.

It is estimated that there are 100,000 people living with sickle-cell disease (SCD) in the United States [1]. The most common manifestation of SCD is vaso-occlusive crisis, which is characterized by intermittent, unexpected episodes of excruciating pain. As these episodes often come on suddenly, much of the care for these crises occurs within emergency departments (EDs). Several studies have examined ED use and costs for certain groups of patients with SCD [2-4]. For example, in 1997, Woods et al. [2] found that 85.7% of 7,202 hospital admissions for SCD in Illinois were for patients that came through the ED, and the total charges for sickle-cell admissions in Illinois were found to be $30 million a year. A recent study of healthcare use by children with SCD demonstrated that children insured by Medicaid had higher ED utilization than those with private insurance (57% vs.45%) [5]. The purpose of our study was to provide national level estimates of ED utilization by SCD patients, which have not previously been available.

Chemoprevention of colorectal cancer: systematic review and economic evaluation.

BACKGROUND: Colorectal cancer (CRC) is the third most common cancer in the UK: incidence increases with age, median age at diagnosis being over 70 years. Approximately 25% of cases occur in individuals with a family history of CRC, including 5% caused by familial adenomatous polyposis (FAP) or hereditary non-polyposis CRC (HNPCC). Most develop from adenomatous polyps arising from the intestine lining. Individuals with these polyps undergo polypectomy and are invited for endoscopic surveillance. Screening via faecal occult blood testing has been rolled out across the UK. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of drug and micronutrient interventions for the prevention of CRC and/or adenomatous polyps. Interventions considered include: non-steroidal anti-inflammatory drugs (NSAIDs), including aspirin and cyclo-oxygenase-2 (COX-2) inhibitors; folic acid; calcium; vitamin D and antioxidants (including vitamin A, vitamin C, vitamin E, selenium and beta-carotene). Chemoprevention was assessed in the general population, in individuals at increased risk of CRC, and in individuals with FAP or HNPCC. DATA SOURCES: A systematic review identified randomised controlled trials (RCTs) assessing drug and nutritional agents for the prevention of CRC or adenomatous polyps. A separate search identified qualitative studies relating to individuals' views, attitudes and beliefs about chemoprevention. MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, CINAHL, the Cochrane Database of Systematic Reviews, Cochrane CENTRAL Register of Controlled Trials, DARE, NHS-EED (NHS Economic Evaluation Database), HTA database, Science Citation Index, BIOSIS previews and the Current Controlled Trials research register were searched in June 2008. Data were extracted by one reviewer and checked by a second. REVIEW METHODS: The synthesis methods used were systematic review and meta-analysis for RCTs and qualitative framework synthesis for qualitative studies. A health economic model was developed to assess the cost-effectiveness of chemoprevention for two populations with different levels of risk of developing CRC: the general population and an intermediate-risk population. RESULTS: The search identified 44 relevant RCTs and six ongoing studies. A small study of aspirin in FAP patients produced no statistically significant reduction in polyp number but a possible reduction in polyp size. There was a statistically significant 21% reduction in risk of adenoma recurrence [relative risk (RR) 0.79, 95% confidence interval (CI) 0.68 to 0.92] in an analysis of aspirin versus no aspirin in individuals with a history of adenomas or CRC. In the general population, a significant 26% reduction in CRC incidence was demonstrated in studies with a 23-year follow-up (RR 0.74, 95% CI 0.57 to 0.97). Non-aspirin NSAID use in FAP individuals produced a non-statistically significant reduction in adenoma incidence after 4 years of treatment and follow-up and reductions in polyp number and size. In individuals with a history of adenomas there was a statistically significant 34% reduction in adenoma recurrence risk (RR 0.66, 95% CI 0.60 to 0.72) and a statistically significant 55% reduction in advanced adenoma incidence (RR 0.45, 95% CI 0.35 to 0.58). No studies assessed the effect of non-aspirin NSAIDs in the general population. There were no studies of folic acid in individuals with FAP or HNPCC. There was no significant effect of folic acid versus placebo on adenoma recurrence (RR 1.16, 95% CI 0.97 to 1.39) or advanced adenoma incidence in individuals with a history of adenomas. In the general population there was no significant effect of folic acid on risk of CRC (RR 1.13, 95% CI 0.77 to 1.64), although studies were of relatively short duration. Calcium use by FAP patients produced no significant reduction in polyp number or disease progression. In individuals with a history of adenomas there was a statistically significant 18% reduction in risk of adenoma recurrence (RR 0.82, 95% CI 0.69 to 0.98) and a non-significant reduction in risk of advanced adenomas (RR 0.77, 95% CI 0.50 to 1.17). In the general population there was no significant effect of calcium on risk of CRC (RR 1.08, 95% CI 0.87 to 1.34), although studies were of relatively short duration. There were no studies of antioxidant use in individuals with FAP or HNPCC, and in individuals with a history of adenomas no statistically significant differences in relative risk of adenoma recurrence were found. In the general population there was no difference in incidence of CRC (RR 1.00, 95% CI 0.88 to 1.13) with antioxidant use compared with no antioxidant use. Twenty studies reported qualitative findings concerning chemoprevention. People are more likely to use NSAIDs if there is a strong perceived need. Perceptions of risk and benefit also influence decision-making and use. People have fewer concerns about using antioxidants or other supplements, but their perception of the benefits of these agents is less well-defined. The model analysis suggested that the most cost-effective age-range policy in the general population would be to provide chemoprevention to all individuals within the general population from age 50 to 60 years. The use of aspirin in addition to screening within the general population is likely to result in a discounted cost per life-year gained of around 10,000 pounds and a discounted cost per quality-adjusted life-year (QALY) gained of around 23,000 pounds compared with screening alone. In the intermediate-risk group the most economically viable age-range policy would be to provide chemoprevention to individuals following polypectomy aged 61 to 70 years. Calcium is likely to have a discounted cost per QALY gained of around 8000 pounds compared with screening alone. Although aspirin in addition to screening should be more effective and less costly than screening alone, under the current assumptions of benefits to harms of aspirin and calcium, aspirin is expected to be extendedly dominated by calcium. LIMITATIONS: Whilst a number of studies were included in the review, the duration of follow-up was generally insufficient to detect an effect on cancer incidence. Given the uncertainties and ambiguities in the evidence base, the results of the health economic analysis should be interpreted with caution. CONCLUSIONS: Aspirin and celecoxib may reduce recurrence of adenomas and incidence of advanced adenomas in individuals with an increased risk of CRC and calcium may reduce recurrence of adenomas in this group. COX-2 inhibitors may decrease polyp number in patients with FAP. There is some evidence for aspirin reducing the incidence of CRC in the general population. Both aspirin and NSAIDs are associated with adverse effects so it will be important to consider the risk-benefit ratio before recommending these agents for chemoprevention. The economic analysis suggests that chemoprevention has the potential to represent a cost-effective intervention, particularly when targeted at intermediate-risk populations following polypectomy.

School-linked sexual health services for young people (SSHYP): a survey and systematic review concerning current models, effectiveness, cost-effectiveness and research opportunities.

BACKGROUND: Report based on a service-mapping study and a systematic review concerning sexual health services for young people, either based in or closely linked to schools. OBJECTIVES: To identify current forms of school-based sexual health services (SBSHS) and school-linked sexual health services (SLSHS) in the UK, review and synthesise existing evidence from qualitative and quantitative studies concerning the effectiveness, acceptability and cost-effectiveness of these types of service and to identify potential areas for further research. DATA SOURCES: Electronic databases were searched from 1985 onwards. For published material: the Cochrane Library (1991-), MEDLINE, PREMEDLINE (2007-), CINAHL, EMBASE, AMED, ASSIA (1987-), IBSS, ERIC, PsycINFO, Science Citation Index (SCI) and Social Sciences Citation Index. For unpublished material and grey literature: the Social Care Institute of Excellence Research Register; the National Research Register (1997-), ReFeR; Index to Theses, and HMIC. REVIEW METHODS: A service-mapping questionnaire was circulated to school nurses in all parts of the UK, and semistructured telephone interviews with service coordinators in NHS and local authority (LA) roles were conducted. An evidence synthesis was performed based on a systematic review of the quantitative evidence about service effectiveness, qualitative evidence about user and professional views and a mixed-methods synthesis. A proof-of-concept model for assessing cost-effectiveness was drawn up. RESULTS: Three broad types of UK sexual health service provision were identified. Firstly, SBSHS staffed by school nurses, offering 'minimal' or 'basic' levels of service. Secondly, SBSHS and SLSHS staffed by a multiprofessional team, but not medical practitioners, offering 'basic' or 'intermediate' levels of service. Thirdly, SBSHS and SLSHS staffed by a multiprofessional team, including medical practitioners offering 'intermediate' or 'comprehensive' levels of service. The systematic review showed that SBSHS are not associated with higher rates of sexual activity among young people, nor with an earlier age of first intercourse. There was evidence to show positive effects in terms of reductions in births to teenage mothers, and in chlamydial infection rates among young men, although this evidence coming primarily from the USA. Therefore, the findings need to be tested in relation to UK-based services. Also evidence to suggest that broad-based, holistic service models, not restricted to sexual health, offer the strongest basis for protecting young people's privacy and confidentiality, countering perceived stigmatisation, offering the most comprehensive range of products and services, and maximising service uptake. Findings from the mapping study also indicate that broad-based services, which include medical practitioner input within a multiprofessional team, meet the stated preferences of staff and of young people most clearly. Partnership-based developments of this kind also conform to the broad policy principles embodied in the Every Child Matters framework in the UK and allied policy initiatives. However, neither these service models nor narrower ones have been rigorously evaluated in terms of their impact on the key outcomes of conception rates and sexually transmitted infection (STI) rates, in the UK or in other countries. Therefore, appropriate data were not found to support cost-effectiveness modelling. LIMITATIONS: Low response rate to the questionnaire. Scotland, Wales and Northern Ireland were under-represented. Also, the distinction made in the questionnaire between 'general health' and 'sexual health' services did not prove robust. CONCLUSIONS: There is no single, dominant service model in the UK. The systematic review demonstrated that the evidence base for these services remains limited and uneven, and draws largely on US studies. Qualitative research is needed to develop robust process and outcome indicators for the evaluation of SLSHS/SBSHS in the UK. These indicators could then be used both in local evaluations, and in large, longitudinal studies of service effectiveness and cost-effectiveness. Future research should examine the impact of the differing types of services currently evolving in the UK, encompassing school-based and school-linked models, as well as models with and without medical practitioner involvement.

Dabigatran etexilate for the prevention of venous thromboembolism in patients undergoing elective hip and knee surgery: a single technology appraisal.

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of dabigatran etexilate (DBG) for the prevention of venous thromboembolism (VTE) in patients undergoing elective hip and knee surgery based upon a review of the manufacturer's submission to the NICE as part of the single technology appraisal (STA) process. The submission's evidence came from three reasonable-quality trials comparing DBG with enoxaparin, and a comparison of DBG with fondaparinux based on the relative efficacy and safety as derived from a mixed treatment comparison (MTC) meta-analysis. DBG (220 mg and 150 mg once daily) is not inferior to enoxaparin (40 mg once daily and 30 mg twice daily) in terms of major VTE or VTE-related events (secondary outcome). Meta-analysis shows that 220 mg DBG is not inferior to enoxaparin (40 mg once daily or 30 mg twice daily) in reducing total VTE and all-cause mortality (primary outcome) in total hip or knee replacement, whereas there is uncertainty around the clinical effectiveness of 150 mg DBG for this outcome. In the MTC analysis DBG compared favourably with the other interventions, with the exception of extended enoxaparin and fondaparinux. The adverse event profile was not significantly different in those receiving DBG and those receiving enoxaparin. The submitted two-phase economic model compares DBG with enoxaparin and fondaparinux in total hip and knee replacement. The model structure is appropriate and the model assumptions are reasonable. The health states, costs, utilities and recurrence rates used are considered to be appropriate for the required analysis. The model estimated that at the licensed dose of 220 mg once daily DBG dominates enoxaparin in both total hip replacement and total knee replacement and that at the lower dose of 150 mg once daily DBG dominates enoxaparin in total hip replacement and enoxaparin dominates DBG in total knee replacement. DBG is less cost-effective than fondaparinux in total hip replacement at both doses; the cost per quality-adjusted life-year of fondaparinux versus DBG is 11,111 pounds and 6857 pounds for the higher and lower doses of DBG respectively. In total knee replacement, both DBG doses are dominated by fondaparinux. For DBG versus all comparators in all cases the cost-effectiveness results are based on small incremental cost and health benefits. Weaknesses of the submitted evidence include that methods used for screening studies, data extraction and applying quality assessment criteria to included studies, as well as key details of trials included in the MTC, were not adequately described. In addition, some input parameters into the modelling process are incorrect. The ERG was unable to correct all of these mistakes and the impact on the model results is therefore unknown. The National Institute for Health and Clinical Excellence guidance issued as a result of the STA states that DBG is recommended as an option for the primary prevention of VTE events in adults who have undergone elective total hip or knee replacement surgery.