Development of the What Matters 2 Adults (WM2A) wellbeing measure for Aboriginal and Torres Strait Islander adults.

PURPOSE: As wellbeing is culturally bound, wellbeing measures for Aboriginal and Torres Strait Islander peoples must be culturally relevant and grounded in Aboriginal and Torres Strait Islander values and preferences. We describe the development of a nationally-relevant and culturally grounded wellbeing measure for Aboriginal and Torres Strait Islander adults: the What Matters to Adults (WM2A) measure. METHODS: We used a mixed methods approach to measure development, combining Indigenist methodologies and psychometric methods. Candidate items were derived through a large national qualitative study. Think-aloud interviews (n = 17) were conducted to assess comprehension, acceptability, and wording of candidate items. Two national surveys collected data on the item pool (n = 312, n = 354). Items were analysed using exploratory factor analysis (EFA), and item response theory (IRT) to test dimensionality, local dependence and item fit. A Collaborative Yarning approach ensured Aboriginal and Torres Strait Islander voices were privileged throughout. RESULTS: Fifty candidate items were developed, refined, and tested. Using EFA, an eight factor model was developed. All items met pre-specified thresholds for maximum endorsement frequencies, and floor and ceiling effects; no item redundancy was identified. Ten items did not meet thresholds for aggregate adjacent endorsement frequencies. During Collaborative Yarning, six items were removed based on low factor loadings (<0.4) and twelve due to conceptual overlap, high correlations with other items, endorsement frequencies, and/or low IRT item level information. Several items were retained for content validity. The final measure includes 32 items across 10 domains (Balance & control; Hope & resilience; Caring for others; Culture & Country; Spirit & identity; Feeling valued; Connection with others; Access; Racism & worries; Pride & strength). CONCLUSIONS: The unique combination of Indigenist and psychometric methodologies to develop WM2A ensures a culturally and psychometrically robust measure, relevant across a range of settings and applications.

Assessing feasibility, construct validity, and reliability of a new aged care-specific preference-based quality of life instrument: evidence from older Australians in residential aged care.

BACKGROUND: Quality of Life-Aged Care Consumers (QOL-ACC) is a new older-person-specific quality of life instrument designed for application in quality assessment and economic evaluation in aged care. The QOL-ACC was designed from its inception with older people receiving aged care services ensuring its strong content validity. Given that the QOL-ACC has already been validated in home care settings and a preference-weighted value set developed, we aimed to assess feasibility, construct validity and reliability of the QOL-ACC in residential aged care settings.  METHODS: Individuals living in residential aged care facilities participated in an interviewer-facilitated survey. The survey included the QOL-ACC, QCE-ACC (quality of aged care experience measure) and two other preference-based quality of life instruments (ASCOT and EQ-5D-5L). Feasibility was assessed using missing data and ceiling/floor effects. Construct validity was assessed by exploring the relationship between the QOL-ACC and other instruments (convergent validity) and the QOL-ACC's ability to discriminate varying levels of self-rated health and quality of life. Internal consistency reliability was assessed using Cronbach's alpha (α). RESULTS: Of the 200 residents (mean age, 85 ± 7.7 years) who completed the survey, 60% were female and 69% were born in Australia. One in three participating residents self-rated their health as fair/poor. The QOL-ACC had no missing data but had small floor effects (0.5%) and acceptable ceiling effects (7.5%). It demonstrated moderate correlation with ASCOT (r = 0.51, p < 0.001) and EQ-5D-5L (r = 0.52, p < 0.001) and a stronger correlation with the QCE-ACC (r = 0.57, p < 0.001). Residents with poor self-rated health and quality of life had significantly lower scores on the QOL-ACC. The internal consistency reliability of the QOL-ACC and its dimensions was good (α = 0.70-0.77). CONCLUSIONS: The QOL-ACC demonstrated good feasibility, construct validity and internal consistency reliability to assess aged care-related quality of life. Moderate correlations of the QOL-ACC and other instruments provide evidence of its construct validity and signifies that the QOL-ACC adds non-redundant and non-interchangeable information beyond the existing instruments. A stronger correlation with the QCE-ACC than other instruments may indicate that quality of life is more intimately connected with the care experience than either health- or social-related quality of life in residential aged care settings.

Assessing the construct validity of the Quality-of-Life-Aged Care Consumers (QOL-ACC): an aged care-specific quality-of-life measure.

PURPOSE: To evaluate the construct (convergent and known group) validity of the Quality-of-Life-Aged Care Consumer (QOL-ACC), an older-person-specific quality-of-life measure designed for application in quality assessment and economic evaluation in aged care. METHODS: Convergent validity was assessed by examining relationships with other validated preference-based measures (EQ-5D-5L, ASCOT), quality of aged care experience (QCE-ACC) and life satisfaction (PWI) through an online survey. Known-group validity was assessed by testing the ability to discriminate varying levels of care needs, self-reported health and quality of life. RESULTS: Older people (aged ≥ 65 years) receiving community-aged care (N = 313) responded; 54.6% were female, 41.8% were living alone and 56.8% were receiving higher-level care. The QOL-ACC and its six dimensions were low to moderately and significantly correlated with the EQ-5D-5L (correlation co-efficient range, ρ = 0.39-0.56). The QOL-ACC demonstrated moderate and statistically significant correlations with ASCOT (ρ = 0.61), the QCE-ACC (ρ = 0.51) and the PWI (ρ = 0.70). Respondents with poorer self-reported health status, quality of life and/or higher-level care needs demonstrated lower QOL-ACC scores (P < 0.001), providing evidence of known-group validity. CONCLUSIONS: The study provides evidence of the construct validity of the QOL-ACC descriptive system. A preference-weighted value set is currently being developed for the QOL-ACC, which when finalised will be subjected to further validation assessments.

Palliative home parenteral nutrition: Clinical service evaluation and identifying potential prognostic factors to assist with patient selection.

BACKGROUND AND AIMS: Home parenteral nutrition (HPN) for palliation has little evidence supporting existing guidance. Patient selection remains challenging. We aimed to evaluate use of palliative HPN in our service against ESPEN guidance, and to identify potential prognostic indicators. METHODS: Palliative care patients commenced on HPN were identified. Medical notes, computer records and HPN database were accessed to identify patient demographics, primary diagnosis and aetiology of intestinal failure, blood test results potentially associated with prognosis (eGFR, albumin, CRP, Hb), presence of ascites, and PN duration. By dichotomising blood results Kaplan-Meier survival plots were derived to identify potential associations with survival. RESULTS: From the HPN database of 111 patients, 20 (18%) were identified as palliative. Six were male (30%), median age (interquartile range (IQR)) 56.4 (51.5-66.8) years. Four patients commenced palliative HPN between 2000 and 2006, while 2007-2013 there were 16. The median number (IQR) of nights on HPN was 85 (19-352). The most common indication was gastro-intestinal obstruction (n = 13, 65%) and short bowel syndrome following palliative surgical resection (n = 4, 20%). Kaplan-Meier survival plots identified worse prognosis on HPN if the presenting albumin was ≤30 g/L p = 0.016. CONCLUSION: The use of HPN in palliative care is increasing. Current patient selection meets with ESPEN guidance with respect to aetiology of intestinal failure and length of survival on PN. We suggest that a low albumin (not a marker of malnutrition) may help to predict those who are likely to survive less long on palliative HPN. A multi-centre prospective study, also examining quality of life would help define improved guidance.

Quality in residential care from the perspective of people living with dementia: The importance of personhood.

BACKGROUND: Providing quality care for people with dementia to meet the growing demand for services is a significant challenge to Australia and globally. When it comes to planning for current and future care needs, limited information is available on what people living with dementia and their family members consider the meaning of "quality" in residential care services. OBJECTIVE: To describe the meaning of quality residential care from the perspective of people with cognitive impairment and their family members. DESIGN: Qualitative data collection via in-depth interviews and focus groups was undertaken with people with dementia or cognitive impairment living in residential care or the community (n=15), and family members of people with dementia (n=26). Thematic analysis was undertaken to identify key themes. RESULTS: The theme of supporting personhood was identified as the overarching concept of importance to both people with dementia and their family members and as the foundation for quality care. There were subtle differences in how this concept was expressed by people with dementia themselves and their family members. However, for both groups, access to meaningful activities and opportunities to feel useful and valued were identified as important ways to support personhood in residential care. Separate to this theme of personhood, family members also talked about the importance of a supportive physical environment in the care home, while for the people with dementia themselves maintaining a connection with family was an important contributor to their experience of good quality residential care. CONCLUSIONS: Supporting personhood was identified as a critical key concept underpinning quality residential aged care, from the perspective of both people with cognitive impairment and their family members. This highlights the important contribution that the psychological and social characteristics of care make to providing a good quality residential care experience from the perspective of consumers with dementia.

Adolescent, parent and societal preferences and willingness to pay for meningococcal B vaccine: A Discrete Choice Experiment.

OBJECTIVE: Meningococcal B (MenB) vaccines have been licensed in many countries with private purchase the only option until recently, when a funded programme was introduced in the UK. The aim of this study was to explore adolescent/parental values for a variety of salient vaccine attributes (cost, effectiveness, side effect profile) to assess preferences and willingness-to-pay (WTP) for a MenB vaccine. METHODOLOGY: A national cross-sectional population study was conducted in Australia using Discrete Choice Experiment methodology to assess adolescent/parent/adult preferences for attributes related to MenB vaccine. RESULTS: 2003 adults and 502 adolescents completed the survey in 2013. The majority of participants were willing to be vaccinated with MenB vaccine with vaccination opt-out chosen by 11.9% of adolescents and parents, and 18.2% of non-parent adults. A mixed logit regression model examining adolescent/adult preferences indicated consistent findings; the higher the effectiveness, the longer the duration of protection, the less chance of adverse events and the lower the cost, the more likely respondents were to agree to vaccination. For an ideal MenB vaccine, including the most favoured level of each attribute summed together (90% effectiveness, 10 year duration, 1 injection, no adverse events) adolescents would pay AU$251.60 and parents AU$295.10. Adolescents and parents would pay AU$90.70 or AU$127.20 for 90% vaccine effectiveness vs AU$18.50 or AU$16.70 for 70% effectiveness and would want to be financially compensated for 50% effectiveness; pay AU$63.30 or AU$76.40 for 10 years protection; and pay AU$48.50 or AU$49.20 for no vaccine related adverse events. A slight fever post vaccination was a preferred choice with parents and adolescents willing to pay AU$9.60 or AU$12.30 for this attribute. CONCLUSIONS: Vaccine effectiveness, adverse events and duration of immunity are important drivers for parental and adolescent decisions about WTP for MenB vaccine and should be included in discussions on the benefits, risks and cost.

Palliative parenteral nutrition use in patients with intestinal failure as a consequence of advanced pseudomyxoma peritonei: a case series.

Pseudomyxoma peritonei (PMP) is a rare condition complicated by intra-abdominal spread that can cause multilevel gastrointestinal (GI) obstruction. Parenteral nutrition (PN) use in the context of palliative care and malignancy remains controversial. We describe the use of palliative PN in three patients with progressive PMP causing multilevel GI obstruction and intestinal failure. All patients received > 90 days of PN. PN was safe in this cohort of patients. However, patient selection and the timing of intervention are important factors when considering the initiation of PN.

What sort of follow-up services would Australian breast cancer survivors prefer if we could no longer offer long-term specialist-based care? A discrete choice experiment.

BACKGROUND: Early diagnosis and improved treatment outcomes have increased breast cancer survival rates that, in turn, have led to increased numbers of women undergoing follow-up after completion of primary treatment. The current workload growth is unsustainable for breast cancer specialists who also provide care for women newly diagnosed or with a recurrence. Appropriate and acceptable follow-up care is important; yet, currently we know little about patient preferences. The aim of this study was to explore the preferences of Australian breast cancer survivors for alternative modes of delivery of follow-up services. METHODS: A self-administered questionnaire (online or paper) was developed. The questionnaire contained a discrete choice experiment (DCE) designed to explore patient preferences with respect to provider, location, frequency and method of delivery of routine follow-up care in years 3, 4 and 5 after diagnosis, as well as the perceived value of 'drop-in' clinics providing additional support. Participants were recruited throughout Australia over a 6-month period from May to October 2012. Preference scores and choice probabilities were used to rank the top 10 most preferred follow-up scenarios for respondents. RESULTS: A total of 836 women participated in the study, of whom 722 (86.4%) completed the DCE. In the absence of specialist follow-up, the 10 most valued surveillance scenarios all included a Breast Physician as the provider of follow-up care. The most preferred scenario is a face-to-face local breast cancer follow-up clinic held every 6 months and led by a Breast Physician, where additional clinics focused on the side effects of treatment are also provided. CONCLUSION: Beyond the first 2 years from diagnosis, in the absence of a specialist led follow-up, women prefer to have their routine breast cancer follow-up by a Breast Physician (or a Breast Cancer Nurse) in a dedicated local breast cancer clinic, rather than with their local General Practitioner. Drop-in clinics for the management of treatment related side effects and to provide advice to both develop and maintain good health are also highly valued by breast cancer survivors.

Economic evaluation for protein and energy supplementation in adults: opportunities to strengthen the evidence.

Malnutrition is a costly problem for health care systems internationally. Malnourished individuals require longer hospital stays and more intensive nursing care than adequately nourished individuals and have been estimated to cost an additional £7.3 billion in health care expenditures in the United Kingdom alone. However, treatments for malnutrition have rarely been considered from an economic perspective. The aim of this systematic review was to identify the cost effectiveness of using protein and energy supplementation as a widely used intervention to treat adults with and at risk of malnutrition. Papers were identified that included economic evaluations of protein or energy supplementation for the treatment or prevention of malnutrition in adults. While the variety of outcome measures reported for cost-effectiveness studies made synthesis of results challenging, cost-benefit studies indicated that the savings for the health system could be substantial due to reduced lengths of hospital stay and less intensive use of health services after discharge. In summary, the available economic evidence indicates that protein and energy supplementation in treatment or prevention of malnutrition provides an opportunity to improve patient wellbeing and lower health system costs.

Measuring and valuing quality of life for public health research: application of the ICECAP-O capability index in the Australian general population.

OBJECTIVES: To assess the applicability of the newly developed ICECAP-O capability index in the measurement and valuation of quality of life in a large community based sample of the Australian general population. With origins in Sen's capability theory, the ICECAP-O may more fully encapsulate the multi-dimensional outcomes of public health policies and interventions than traditional health economic constructs. METHODS: 2,937 Australian residents participated in face-to-face interviews. The relationships between ICECAP-O scores according to age groups (<65 or >65 years) and socio-economic status were investigated using descriptive statistics and multivariable linear regression models. RESULTS: Lower income levels and being unemployed or physically unable to work were negatively associated with capability for both age groups. Capability was strongly and positively associated with marriage and cohabitation in the younger age group, whilst being Australian-born was a positive indicator for the older group. CONCLUSIONS: The results provide insights into the assessment of capability in the Australian general population. The ICECAP-O shows promise for application in the measurement and valuation of quality of life in general population surveys, and incorporation into economic evaluations of public health interventions.

A guide for identification and continuing care of adult congenital heart disease patients in primary care.

BACKGROUND: Surgical and other advances in the treatment and care of congenital heart disease have resulted in a significant increase in the number of adults with congenital heart disease (ACHD), many of whom have no regular cardiology follow-up. Optimised care for ACHD patients requires continuity of specialist and shared care and education of practitioners and patients. The challenges for managing ACHD were identified by a Health Needs Assessment in the North West and are addressed within the UK Department of Health's ACHD Commissioning Guide. MATERIALS AND METHODS: An ACHD model of care was recommended in the North West of England and developed by the three North West Cardiac & Stroke Networks. Within this, a Task Group focused on the role of primary care in the identification and continuing care of ACHD patients. A feasibility study demonstrated that existing diagnostic Read Codes can identify ACHD patients on general practice registers. An ACHD Toolkit was developed to provide algorithms to guide the appropriate management of ACHD patients through primary, secondary and/or specialist ACHD care and to improve education/knowledge amongst primary care staff about ACHD and its wider implications. RESULTS: Early findings during the development of this Toolkit illustrate a wide disparity of provision between current and optimal management strategies. Patients lost to follow-up have already been identified and their management modified. CONCLUSIONS: By focusing on identifying ACHD patients in primary care and organising/delivering ACHD services, the ACHD Toolkit could help to improve quality, timeliness of care, patient experience and wellbeing.

Comparison of case note review methods for evaluating quality and safety in health care.

OBJECTIVES: To determine which of two methods of case note review--holistic (implicit) and criterion-based (explicit)--provides the most useful and reliable information for quality and safety of care, and the level of agreement within and between groups of health-care professionals when they use the two methods to review the same record. To explore the process-outcome relationship between holistic and criterion-based quality-of-care measures and hospital-level outcome indicators. DATA SOURCES: Case notes of patients at randomly selected hospitals in England. REVIEW METHODS: In the first part of the study, retrospective multiple reviews of 684 case notes were undertaken at nine acute hospitals using both holistic and criterion-based review methods. Quality-of-care measures included evidence-based review criteria and a quality-of-care rating scale. Textual commentary on the quality of care was provided as a component of holistic review. Review teams comprised combinations of: doctors (n = 16), specialist nurses (n = 10) and clinically trained audit staff (n = 3) and non-clinical audit staff (n = 9). In the second part of the study, process (quality and safety) of care data were collected from the case notes of 1565 people with either chronic obstructive pulmonary disease (COPD) or heart failure in 20 hospitals. Doctors collected criterion-based data from case notes and used implicit review methods to derive textual comments on the quality of care provided and score the care overall. Data were analysed for intrarater consistency, inter-rater reliability between pairs of staff using intraclass correlation coefficients (ICCs) and completeness of criterion data capture, and comparisons were made within and between staff groups and between review methods. To explore the process-outcome relationship, a range of publicly available health-care indicator data were used as proxy outcomes in a multilevel analysis. RESULTS: Overall, 1473 holistic and 1389 criterion-based reviews were undertaken in the first part of the study. When same staff-type reviewer pairs/groups reviewed the same record, holistic scale score inter-rater reliability was moderate within each of the three staff groups [intraclass correlation coefficient (ICC) 0.46-0.52], and inter-rater reliability for criterion-based scores was moderate to good (ICC 0.61-0.88). When different staff-type pairs/groups reviewed the same record, agreement between the reviewer pairs/groups was weak to moderate for overall care (ICC 0.24-0.43). Comparison of holistic review score and criterion-based score of case notes reviewed by doctors and by non-clinical audit staff showed a reasonable level of agreement (p-values for difference 0.406 and 0.223, respectively), although results from all three staff types showed no overall level of agreement (p-value for difference 0.057). Detailed qualitative analysis of the textual data indicated that the three staff types tended to provide different forms of commentary on quality of care, although there was some overlap between some groups. In the process-outcome study there generally were high criterion-based scores for all hospitals, whereas there was more interhospital variation between the holistic review overall scale scores. Textual commentary on the quality of care verified the holistic scale scores. Differences among hospitals with regard to the relationship between mortality and quality of care were not statistically significant. CONCLUSIONS: Using the holistic approach, the three groups of staff appeared to interpret the recorded care differently when they each reviewed the same record. When the same clinical record was reviewed by doctors and non-clinical audit staff, there was no significant difference between the assessments of quality of care generated by the two groups. All three staff groups performed reasonably well when using criterion-based review, although the quality and type of information provided by doctors was of greater value. Therefore, when measuring quality of care from case notes, consideration needs to be given to the method of review, the type of staff undertaking the review, and the methods of analysis available to the review team. Review can be enhanced using a combination of both criterion-based and structured holistic methods with textual commentary, and variation in quality of care can best be identified from a combination of holistic scale scores and textual data review.

Supplementary prescribing by community and primary care pharmacists: an analysis of PACT data, 2004-2006.

BACKGROUND AND OBJECTIVE: Pharmacist prescribing is a relatively new initiative in the extension of prescribing responsibilities to non-medical healthcare professionals. Pharmacist supplementary prescribing was introduced in 2003 and allowed prescribing in accordance with a clinical management plan agreed with a medical practitioner and patient to improve patient access to medicines and better utilize the skills of healthcare professionals. The objective of this research was to examine the volume, cost and trends in pharmacist prescribing in community and primary care using Prescription Analysis and Cost (PACT) data and to suggest possible reasons for the trends. METHODS: Using PACT data at national, chapter and subchapter level for 2004-2006 the volume, costs and trends for pharmacist prescribing were obtained. Supplemental data and statistical analysis from other sources, relating to prescribing of individual drugs, were also utilized. RESULTS: The total number of items prescribed by pharmacists in community and primary care increased from 2706 in 2004 to 31 052 in 2006. In 2006, pharmacist prescribing represented only 0.004% of all prescribing in the community and primary care setting. Cardiovascular medicines were the most frequently prescribed therapeutic class followed by central nervous system, respiratory, endocrine and gastrointestinal medicines. CONCLUSION: Pharmacist prescribing is increasing but represents an extremely small proportion of primary care prescribing. PACT data between 2004 and 2006 reflects pharmacist supplementary prescribing alone and has been in the anticipated therapeutic areas of drugs which treat chronic conditions such as hypertension.

Detection of ESBL bacteria from clinical specimens: evaluation of a new selective medium.

Selective screening media for extended-spectrum beta-lactamase (ESBL)-producing bacteria are needed to guide antibiotic therapy and institute appropriate infection control measures. This study evaluates a selective cefpodoxime-incorporated chromogenic agar (CCA) medium for the detection of ESBLs from clinical specimens. The medium was formulated specifically for this study. For all culture-positive urine samples and wound swabs from intensive care unit (ICU) patients, CCA was compared with standard laboratory testing procedures and HPA/BSAC guidance on ESBL detection. The CCA medium was also evaluated for ESBL faecal carriage from patients on ICU and the haematology ward. These patients had no prior evidence of colonisation or infection with ESBL-producing bacteria. All ESBL isolates underwent minimum inhibitory concentration (MIC) testing to cefpodoxime. The Miles and Misra method and the ecometric methods were used to quality control the microbiological performance of the CCA medium, which proved satisfactory. A total of 750 specimens were examined (690 urines, 40 faeces, 20 wound swabs). From urine cultures, 92 suspect colonies were followed up. Eighteen were cefpodoxime-resistant on routine disc testing and all were confirmed subsequently as ESBL-positive. Conventional laboratory methods identified only two urinary ESBLs. Wound cultures revealed two suspect colonies, both of which were ESBL-positive and were also detected by routine methods. Faecal samples produced 10 suspect colonies, six of which were ESBL-positive. All ESBLs had cefpodoxime MICs >10 mg /L (75% were >256 mg/L). Thus, primary conventional culture methods cannot be relied upon to detect suspect ESBL-producing bacteria.

A randomised controlled trial of acupuncture care for persistent low back pain: cost effectiveness analysis.

OBJECTIVE: To evaluate the cost effectiveness of acupuncture in the management of persistent non-specific low back pain. DESIGN: Cost effectiveness analysis of a randomised controlled trial. SETTING: Three private acupuncture clinics and 18 general practices in York, England. PARTICIPANTS: 241 adults aged 18-65 with non-specific low back pain of 4-52 weeks' duration. INTERVENTIONS: Ten individualised acupuncture treatments over three months from acupuncturists trained in traditional Chinese medicine (n = 160) or usual care only (n = 81). MAIN OUTCOME MEASURE: Incremental cost per quality adjusted life year (QALY) gained over two years. RESULTS: Total costs to the United Kingdom's health service during the two year study period were higher on average for the acupuncture group (460 pounds sterling; 673 euros; 859 dollars) than for the usual care group (345 pounds sterling) because of the costs associated with initial treatment. The mean incremental health gain from acupuncture at 12 months was 0.012 QALYs (95% confidence interval -0.033 to 0.058) and at 24 months was 0.027 QALYs (-0.056 to 0.110), leading to a base case estimate of 4241 pounds sterling per QALY gained. This result was robust to sensitivity analysis. The probabilistic sensitivity analysis showed acupuncture to have a more than 90% chance of being cost effective at a pound20 000 cost per QALY threshold. CONCLUSION: A short course of traditional acupuncture for persistent non-specific low back pain in primary care confers a modest health benefit for minor extra cost to the NHS compared with usual care. Acupuncture care for low back pain seems to be cost effective in the longer term. TRIAL REGISTRATION: ISRCTN80764175 [controlled-trials.com].

Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial).

OBJECTIVES: To establish the cost-effectiveness of surgery and sclerotherapy for the treatment of varicose veins. DESIGN: Randomised controlled trials (RCTs) were carried out for conservative treatment, sclerotherapy and surgery for varicose veins. An economic analysis was carried out alongside the randomised trial. Economic modelling was undertaken based on the primary data collection and a literature review (database searches undertaken in April 2000 and updated in March 2001). SETTING: Primary data collection was from a large district general hospital and a teaching hospital both in England over a 2-year period from January 1999. Cost-effectiveness analysis and economic modelling were carried out using an NHS perspective. PARTICIPANTS: A total of 1009 patients were recruited. INTERVENTIONS: Thirty-four patents were randomised in Group 1 (minor varicose veins with no reflux, randomised between conservative treatment and sclerotherapy), 77 in Group 2 (moderate varicose veins with reflux, randomised between surgery and sclerotherapy) and 246 in Group 3 (severe varicose veins with reflux, randomised between conservative treatment and surgery). The remaining 652 patients formed the observational part of the study. MAIN OUTCOME MEASURES: The cost-effectiveness analysis was based on NHS treatment costs for the 2002--3 financial year, and utilities based on the Short Form 6D (SF-6D) preference-based health measure. For the clinical trial, the outcome measures were health-related quality of life (HRQoL) [Short Form with 36 Items (SF-36), EuroQol quality of life questionnaire (EQ-5D), visual analogue scale (VAS) and standard gamble], symptomatic relief, anatomical extent (for which a new classification was developed and validated), patient satisfaction and the incidence of complications. RESULTS: Of the RCTs, only the Group 3 trial was large enough to provide clear results. This showed that surgical treatment produced better results than conservative treatment in terms of HRQoL, symptomatic relief, anatomical extent and patient satisfaction. Clinical outcomes of surgery and sclerotherapy showed significant improvement in the extent of varicose veins, symptomatic and HRQoL parameters. Cost-effectiveness analysis based on the Group 3 trial showed that the surgery produced an estimated discounted benefit of 0.054 quality-adjusted life-year (QALY) over a 2-year period, with an additional discounted cost of pound 387.45, giving an incremental cost-effectiveness ratio (ICER) of pound 7175 per QALY. Economic modelling suggested that surgery produced a still greater benefit when considered with a 10-year time horizon, with an ICER of pound 1936 per QALY. Injection sclerotherapy produced an incremental benefit of approximately 0.044 QALY at a cost of pound 155 when compared with conservative treatment, giving an ICER of pound 3500 per QALY. When surgery was compared with sclerotherapy, surgery produced greater benefit with a lower ICER (showing extended dominance). CONCLUSIONS: Standard surgical treatment of varicose veins by saphenofemoral ligation, stripping and multiple phlebectomies is a clinically effective and cost-effective treatment for varicose veins, with an ICER well below the threshold normally considered appropriate for the funding of treatments within the NHS. Injection sclerotherapy also appears to be cost-effective, but produces less overall benefit, with a higher ICER than surgery for patients with superficial venous reflux. In minor varicose veins without reflux, sclerotherapy is likely to provide a small average benefit with acceptable cost-effectiveness. Research is needed into methods for accurate and acceptable utility evaluations for conditions with relatively minor effect on HRQoL and also for a validated and standardised method of classification for varicose veins.

The evolution of the emergency care practitioner role in England: experiences and impact.

BACKGROUND: The emergency care practitioner (ECP) is a generic practitioner who combines extended nursing and paramedic skills. The "new" role emerged out of changing workforce initiatives intended to improve staff career opportunities in the National Health Service and ensure that patients' health needs are assessed appropriately. OBJECTIVE: To describe the development of ECP Schemes in 17 sites, identify criteria contributing to a successful operational framework, analyse routinely collected data and provide a preliminary estimate of costs. METHODS: There were three methods used: (a) a quantitative survey, comprising a questionnaire to project leaders in 17 sites, and analysis of data collected routinely; (b) qualitative interpretation based on telephone interviews in six sites; and (c) an economic costing study. RESULTS: Of 17 sites, 14 (82.5%) responded to the questionnaire. Most ECPs (77.4%) had trained as paramedics. Skills and competencies have been extended through educational programmes, training, and assessment. Routine data indicate that 54% of patient contacts with the ECP service did not require a referral to another health professional or use of emergency transport. In a subset of six sites, factors contributing to a successful operational framework were strategic visions crossing traditional organisational boundaries and appropriately skilled workforce integrating flexibly with existing services. Issues across all schemes were patient safety, appropriate clinical governance, and supervision and workforce issues. On the data available, the mean cost per ECP patient contact is 24.00 pounds sterling, which is less than an ED contact of 55.00 pounds sterling. CONCLUSION: Indications are that the ECP schemes are moving forward in line with original objectives and could be having a significant impact on the emergency services workload.

Cost-effectiveness analysis of surgery versus conservative treatment for uncomplicated varicose veins in a randomized clinical trial.

BACKGROUND: Despite being a common procedure, the cost effectiveness of surgery for varicose veins has not been established. METHODS: Cost-effectiveness analysis was carried out alongside a randomized clinical trial at two vascular units within National Health Service (NHS) hospitals. Some 246 patients with uncomplicated varicose veins and evidence of saphenofemoral or saphenopopliteal reflux were allocated randomly to receive either conservative management or surgical treatment. Incremental cost per quality-adjusted life year (QALY) gained at 24 months following randomization was calculated. RESULTS: Total NHS costs during the 2-year study period were higher for the surgically treated group (733 UK pounds) than for those who had conservative treatment (345 UK pounds). The difference in costs was statistically significant. The mean incremental health gain from surgical treatment at 24 months was 0.083 QALYs, leading to a base-case estimate of 4682 UK pounds per QALY gained. Assuming an implicit threshold maximum willingness-to-pay value of 20 000 UK pounds for a QALY, the probability of surgical treatment for varicose veins falling below this threshold value was 70 per cent. This result was found to be robust to sensitivity analysis. CONCLUSION: For patients with uncomplicated varicose veins and evidence of saphenofemoral or saphenopopliteal reflux, surgical treatment for varicose veins offers a modest health benefit for relatively little additional NHS cost relative to conservative treatment.

Randomized clinical trial comparing surgery with conservative treatment for uncomplicated varicose veins.

BACKGROUND: Surgical treatment of medically uncomplicated varicose veins is common, but its clinical effectiveness remains uncertain. METHODS: A randomized clinical trial was carried out at two large acute National Health Service hospitals in different parts of the UK (Sheffield and Exeter). Some 246 patients were recruited from 536 consecutive referrals to vascular outpatient clinics with uncomplicated varicose veins suitable for surgical treatment. Conservative management, consisting of lifestyle advice, was compared with surgical treatment (flush ligation of sites of reflux, stripping of the long saphenous vein and multiple phlebectomies, as appropriate). Changes in health status were measured using the Short Form (SF) 6D and EuroQol (EQ) 5D, quality of life instruments based on SF-36 and EuroQol, complications of treatment, symptomatic measures, anatomical extent of varicose veins and patient satisfaction. RESULTS: In the first 2 years after treatment there was a significant quality of life benefit for surgery of 0.083 (95 per cent confidence interval (c.i.) 0.005 to 0.16) quality-adjusted life years (QALYs) based on the SF-6D score and 0.13 (95 per cent c.i. 0.016 to 0.25) based on the EQ-5D score. Significant benefits were also seen in symptomatic and anatomical measures. CONCLUSION: Surgical treatment provides symptomatic relief and significant improvements in quality of life in patients referred to secondary care with uncomplicated varicose veins.