Systematic review of patient-reported outcome measures in patients with varicose veins.

BACKGROUND: Varicose veins can affect quality of life. Patient-reported outcome measures (PROMs) provide a direct report from the patient about the impact of the disease without interpretation from clinicians or anyone else. The aim of this study was to examine the quality of the psychometric evidence for PROMs used in patients with varicose veins. METHODS: A systematic review was undertaken to identify studies that reported the psychometric properties of generic and disease-specific PROMs in patients with varicose veins. Literature searches were conducted in databases including MEDLINE, up to July 2016. The psychometric criteria used to assess these studies were adapted from published recommendations in accordance with US Food and Drug Administration guidance. RESULTS: Nine studies were included which reported on aspects of the development and/or validation of one generic (36-Item Short Form Health Survey, SF-36®) and three disease-specific (Aberdeen Varicose Vein Questionnaire, AVVQ; Varicose Veins Symptoms Questionnaire, VVSymQ®; Specific Quality-of-life and Outcome Response - Venous, SQOR-V) PROMs. The evidence from included studies provided data to support the construct validity, test-retest reliability and responsiveness of the AVVQ. However, its content validity, including weighting of the AVVQ questions, was biased and based on the opinion of clinicians, and the instrument had poor acceptability. VVSymQ® displayed good responsiveness and acceptability rates. SF-36® was considered to have satisfactory responsiveness and internal consistency. CONCLUSION: There is a scarcity of psychometric evidence for PROMs used in patients with varicose veins. These data suggest that AVVQ and SF-36® are the most rigorously evaluated PROMs in patients with varicose veins.

Systematic review and qualitative evidence synthesis of patient-reported outcome measures for abdominal aortic aneurysm.

BACKGROUND: The aim was to identify and evaluate existing patient-reported outcome measures (PROMs) for use in patients with an abdominal aortic aneurysm (AAA) to inform the selection for use in surgical practice. METHODS: Two reviews were conducted: a systematic review to identify valid, reliable and acceptable PROMs for patients with an AAA, and a qualitative evidence synthesis to assess the relevance to patients of the identified PROM items. PROM studies were evaluated for their psychometric properties using established assessment criteria, and for their methodological quality using the COSMIN checklist. Qualitative studies were synthesized using framework analysis, and concepts identified were then triangulated using a protocol with the item concepts of the identified PROMs. RESULTS: Four PROMs from three studies were identified in the first review: Short Form 36, Australian Vascular Quality of Life Index, Aneurysm Dependent Quality of Life (AneurysmDQoL) and Aneurysm Symptoms Rating Questionnaire (AneurysmSRQ). None of the identified PROMs had undergone a rigorous psychometric evaluation within the AAA population. Four studies were included in the qualitative synthesis, from which 28 concepts important to patients with an AAA were identified. The AneurysmDQoL and AneurysmSRQ together provided the most comprehensive assessment of these concepts. Fear of rupture, control, ability to forget about the condition and size of aneurysm were all concepts identified in the qualitative studies but not covered by items in the identified PROMs. CONCLUSION: Further research is needed to develop PROMs for AAA that are reliable, valid and acceptable to patients.

Systematic review of carotid artery procedures and the volume-outcome relationship in Europe.

BACKGROUND: Hospitals that conduct more procedures on the carotid arteries may achieve better outcomes. In the context of ongoing reconfiguration of UK vascular services, this systematic review was conducted to evaluate the relationship between the volume of carotid procedures and outcomes, including mortality and stroke. METHODS: Searches of electronic databases identified studies that reported the effect of hospital or clinician volume on outcomes. Reference and citation searches were also performed. Inclusion was restricted to European populations on the basis that the model of healthcare delivery is similar across Europe, but differs from that in the USA and elsewhere. Analyses of hospital and clinician volume, and carotid endarterectomy (CEA) and carotid artery stenting (CAS) were conducted separately. RESULTS: Eleven eligible studies were identified (233 411 participants), five from the UK, two from Sweden, one each from Germany, Finland and Italy, and a combined German, Austrian and Swiss population. All studies were observational. Two large studies (179 736 patients) suggested an inverse relationship between hospital volume and mortality (number needed to treat (NNT) as low as 165), and combined mortality and stroke (NNT as low as 93), following CEA. The evidence was less clear for CAS; multiple analyses in three studies did not identify convincing evidence of an association. Limited data are available on the relationship between clinician volume and outcome in CAS; in CEA, an inverse relationship was identified by two of three small studies. CONCLUSION: The evidence from the largest and highest-quality studies included in this review support the centralization of CEA.

Procedure Volume and the Association with Short-term Mortality Following Abdominal Aortic Aneurysm Repair in European Populations: A Systematic Review.

OBJECTIVE: To evaluate the relationship between the volume of abdominal aortic aneurysm (AAA) procedures undertaken and the primary outcome of mortality in Europe. Previous systematic reviews of this relationship are outdated and are overwhelmingly based on US data. DATA SOURCES: Comprehensive searching within MEDLINE and other bibliographic databases supplemented by citation searching and hand-searching of journals was undertaken to identify studies that reported the effect of hospital or clinician volume on any reported outcomes in adult, European populations, undergoing AAA repair and published in the last 10 years. METHODS: Two reviewers conducted study selection with independent, duplicate data extraction and quality assessment. A planned meta-analysis was not conducted because of the high risk of bias, the likelihood of individual study subjects being included in more than one study and diversity in the clinical populations studied and methods used. RESULTS: Sixteen studies (n = 237,074 participants) from the UK (n = 11 studies), Germany (n = 3 studies), Norway (n = 1 study), and one from the UK and Sweden were included. Data in the included studies came from administrative databases and clinical registries incorporating a variety of clinical and procedural groups; the study quality was limited by the use of observational study designs. Overall, the evidence favoured the existence of an inverse volume outcome relationship between hospital volume and mortality. Insufficient evidence was available to reach conclusions on the relationship between clinician volume and outcome and between hospital or clinician volume and secondary outcomes including complications and length of hospital stay. CONCLUSIONS: The evidence from this review suggests a relationship between the hospital volume of AAA procedures conducted and short-term mortality; however, as volume typically represents a complex amalgamation of factors further research will be useful to identify the core characteristics of volume that influence improved outcomes.

clinical risk factors for osteoporosis in Ireland and the UK: a comparison of FRAX and QFractureScores.

Recently two algorithms have become available to estimate the 10-year probability of fracture in patients suspected to have osteoporosis on the basis of clinical risk factors: the FRAX algorithm and QFractureScores algorithm (QFracture). The aim of this study was to compare the performance of these algorithms in a study of fracture patients and controls recruited from six centers in the United Kingdom and Ireland. A total of 246 postmenopausal women aged 50-85 years who had recently suffered a low-trauma fracture were enrolled and their characteristics were compared with 338 female controls who had never suffered a fracture. Femoral bone mineral density was measured by dual-energy X-ray absorptiometry, and fracture risk was calculated using the FRAX and QFracture algorithms. The FRAX algorithm yielded higher scores for fracture risk than the QFracture algorithm. Accordingly, the risk of major fracture in the overall study group was 9.5% for QFracture compared with 15.2% for FRAX. For hip fracture risk the values were 2.9% and 4.7%, respectively. The correlation between FRAX and QFracture was R = 0.803 for major fracture and R = 0.857 for hip fracture (P ≤ 0.0001). Both algorithms yielded high specificity but poor sensitivity for prediction of osteoporosis. We conclude that the FRAX and QFracture algorithms yield similar results in the estimation of fracture risk. Both of these tools could be of value in primary care to identify patients in the community at risk of osteoporosis and fragility fractures for further investigation and therapeutic intervention.

Comparative analysis of hatcheries contribution to poor development of day-old chicks based on biological and immunological performance.

BACKGROUND AND AIM: The quality of day-old chicks is a cornerstone to successful poultry production. Chicks with a poor quality start slowly in the field and may have high feed intake, poor growth rate, and poor feed conversion ratio. The current study aimed to assess chick quality challenges encountered from day-old chicks hatched in most commercial hatcheries in Ghana. MATERIALS AND METHODS: A total of 300 day-old chicks each were obtained from commercial hatcheries in Ghana and Europe. The chicks were labeled as locally hatched broiler day-old chicks (LBDOC) and foreign hatched broiler day-old chicks (FBDOC), respectively. Chicks were reared and monitored from day old to 21 days post-hatch. Sample of chicks (n=25) from each hatchery was euthanized weekly at 1, 7, 14, and 21 days and blood samples collected for analysis. The parameters measured included physical, hematological, immunological, histological, and bacteriological characteristics. All data were analyzed by SAS Proc GLM at p<0.05. RESULTS: The live weight of chicks was higher in FBDOC compared to LBDOC on the 1st day. The chick length and shank length of FBDOC were longer than the LBDOC. The 7-day chick mortality was 6% in LBDOC as compared to 1.5% in FBDOC. The LBDOC also had a higher wet and dry residual yolk sac percentages as well as higher residual yolk sac fluid volume than the FBDOC. The rate of yolk sac disappearance of the FBDOC was higher than the LBDOC. More than half of the LBDOC had developed navel strings and leaky navel compared to FBDOC. The LBDOC recorded Escherichia coli, Proteus, Streptococcus spp., and Gram-negative bacteria in the residual yolk sac isolated through the 21 days while FBDOC recorded E. coli, Proteus, and Gram-negative bacteria. The intestinal villi count, lengths, width, and surface area were all not significantly different. The blood monocyte levels appeared higher in FBDOC than LBDOC, which give evidence of higher immunity in FBDOC than LBDOC. CONCLUSION: The results indicate a challenging situation in maintaining the quality of locally hatched broiler day-old-chicks compared to foreign hatched broiler-day-old-chicks. The study demonstrates that chick quality impact goes beyond the physical characteristics of chick weight and chick length, and the higher performance of FBDOC may be influenced by compliance with international hatchery standards and vaccination protocols.

Systematic review assessing the measurement properties of patient-reported outcomes for venous leg ulcers.

BACKGROUND: A variety of instruments have been used to assess outcomes for patients with venous leg ulcers. This study sought to identify, evaluate and recommend the most appropriate patient-reported outcome measures (PROMs) for English-speaking patients with venous leg ulcers. METHODS: This systematic review used a two-stage search approach. Electronic searches of major databases including MEDLINE were completed in October 2015, and then updated in July 2016. Additional studies were identified from citation checking. Study selection, data extraction and quality assessment were undertaken independently by at least two reviewers. Evaluation and summary of measurement properties of identified PROMs were done using standard and adapted study-relevant criteria. RESULTS: Ten studies with data for four generic PROMS and six condition-specific measures were identified. No generic PROM showed adequate content and criterion validity; however, the EuroQoL Five Dimensions (EQ-5D™), Nottingham Health Profile (NHP) and 12-item Short-Form Health Survey (SF-12®) had good acceptability. In general, the EQ-5D™ showed poor responsiveness in patients with venous leg ulcers. Most condition-specific PROMs demonstrated poor criterion and construct validity. Overall, there was some evidence of internal consistency for the Venous Leg Ulcer Quality of Life (VLU-QoL) and the Sheffield Preference-based Venous Ulcer questionnaire (SPVU-5D). Test-retest reliability was satisfactory for the Venous Leg Ulcer Self-Efficacy Tool (VeLUSET). CONCLUSION: The NHP and VLU-QoL questionnaire seemed the most suitable PROMs for use by clinicians. However, a valid condition-specific PROM is still required.

Echocardiography in newly diagnosed atrial fibrillation patients: a systematic review and economic evaluation.

OBJECTIVE: To investigate the clinical effectiveness and cost-effectiveness of transthoracic echocardiography (TTE) in all patients who are newly diagnosed with atrial fibrillation (AF). DESIGN: Narrative synthesis reviews were conducted on the prognostic and diagnostic accuracy of TTE for, and prevalence of, pathologies in patients with AF. Databases were searched from inception. MEDLINE searches were conducted from March to August 2010, and reference lists of articles checked. There were 44 diagnostic accuracy studies, five prognostic studies, and 16 prevalence studies accepted into the review. Given the complexity of the many pathologies identified by TTE, the variety of potential changes to clinical management, and paucity of data, the model focused on changes to oral anticoagulation (OAC). The mathematical model assessed the cost-effectiveness of TTE for patients with AF who were not routinely given OAC, assuming, if left atrial abnormality was detected, that the higher risk of stroke warranted OAC; this meant that patients with a CHADS2 (cardiac failure, hypertension, age, diabetes, stroke doubled) score of 0 [dabigatran etexilate (Pradaxa, Boehringer Ingelheim)/rivaroxaban (Xarelto, Bayer Schering)] or 0/1 (warfarin) were included. A simplified approach evaluated the additional quality-adjusted life-years (QALYs) required in order for TTE to be perceived as cost-effective at a threshold of £20,000 per QALY. SETTING: Transthoracic echocardiography is usually performed in cardiology clinics but may be used in primary or non-specialist secondary care. PARTICIPANTS: Patients with newly diagnosed AF. INTERVENTION: Transthoracic echocardiography. MAIN OUTCOME MEASURES: Prognosis, diagnostic sensitivity or specificity of TTE, prevalence of pathologies in patients with AF, cost-effectiveness and QALYs. RESULTS: Prognostic studies indicated that TTE-diagnosed left ventricular dysfunction, increased left atrial diameter and valvular abnormality were significantly associated with an increased risk of stroke, mortality or thromboembolism. There was a high prevalence (around 25-30%) of ischaemic heart disease, valvular heart disease and heart failure in patients with AF. Diagnostic accuracy of TTE was high, with most pathologies having specificity of ≥ 0.8 and sensitivity of ≥ 0.6. The mathematical model predicted that when the CHADS2 tool is used the addition of TTE in identifying patients with left atrial abnormality appears to be cost-effective for informing some OAC decisions. In the simplified approach a threshold of 0.0033 was required for a TTE to be cost-effective. CONCLUSIONS: When CHADS2 was used, the addition of TTE in identifying patients with left atrial abnormality was cost-effective for informing some OAC decisions. A simple analysis indicates that the number of QALYs required for TTE to be cost-effective is small, and that if benefits beyond those associated with a reduction in stroke are believed probable then TTE is likely to be cost-effective in all scenarios. Our findings suggest that further research would be useful, following up newly diagnosed patients with AF who have undergone TTE, to study treatments given as a result of TTE diagnoses and subsequent cardiovascular events. This could identify additional benefits of routine testing, beyond stroke prevention. Studies assessing the proportion of people with a CHADS2 score of 0 or 1 that have left atrial abnormality would provide better estimates of the cost-effectiveness of TTE, and allow more accurate estimates of the sensitivity and specificity of TTE for identifying left atrial abnormality in AF to be obtained. STUDY REGISTRATION: PROSPERO CRD42011001354. FUNDING: The National Institute for Health Research Health Technology Assessment programme.