Intrathecal drug delivery systems for the management of chronic non-cancer pain : a systematic review of economic evaluations

Background: Intrathecal drug delivery (ITDD) systems are one of a limited number of management options for chronic non-cancer pain, cancer pain and spasticity. Concerns over their effectiveness and high initial costs led NHS England to decommission ITDD for patients with chronic non-cancer pain. However, the extent to which this decision is in line with existing economic evidence is unclear. The aim of this systematic review is to identify and review the existing evidence on the cost-effectiveness of ITDD for chronic non-cancer pain. Methods: Full and partial economic evaluations on ITDD were identified through systematic searches in MEDLINE, EMBASE, Web of Science and the National Health Service Centre for Reviews and Dissemination databases. Database searches were complemented by hand searching of reference lists of relevant studies and searches of grey literature. Study selection was carried out by two assessors, independently. Study quality assessment was performed to inform critical appraisal of health economics studies. Data were extracted using a data extraction form developed for this study. Results: 4464 unique studies were identified, of which seven met the inclusion criteria. With the exception of one study, the studies found ITDD to be either cost-saving or cost-effective compared to conventional medical management. ITDD becomes cost-ineffective in one further study following price year adjustment to 2016. Conclusions: Study findings show ITDD as not cost-effective only in extremely conservative scenarios. There is limited evidence on the effectiveness of ITDD in non-cancer pain; however, the available economic evidence controverts arguments to refute the treatment on economic grounds

Bluebelle pilot randomised controlled trial of three wound dressing strategies to reduce surgical site infection in primary surgical wounds

Objective Surgical site infection (SSI) affects up to 25% of primary surgical wounds. Dressing strategies may influence SSI risk. The Bluebelle study assessed the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of different dressing strategies to reduce SSI in primary surgical wounds. Design A pilot, factorial RCT. Setting Five UK hospitals. Participants Adults undergoing abdominal surgery with a primary surgical wound. Interventions Participants were randomised to ‘simple dressing’, ‘glue-as-a-dressing’ or ‘no dressing’, and to the time at which the treatment allocation was disclosed to the surgeon (disclosure time, before or after wound closure). Primary and secondary outcome measures Feasibility outcomes focused on recruitment, adherence to randomised allocations, reference assessment of SSI and response rates to participant-completed and observer-completed questionnaires to assess SSI (proposed primary outcome for main trial), wound experience and symptoms, and quality of life (EQ-5D-5L). Results Between March and November 2016, 1115 patients were screened; 699 (73.4%) were eligible and approached, 415 (59.4%) consented and 394 (35.3%) were randomised (simple dressing=133, glue=129 and ‘no dressing’=132). Non-adherence to dressing allocation was 2% (3/133), 6% (8/129) and 15% (20/132), respectively. Adherence to disclosure time was 99% and 86% before and after wound closure, respectively. The overall rate of SSI (reference assessment) was 18.1% (51/281). Response rates to the Wound Healing Questionnaire and other questionnaires ranged from >90% at 4 days to 68% at 4–8 weeks. Conclusions A definitive RCT of dressing strategies including ‘no dressing’ is feasible. Further work is needed to optimise questionnaire response rates

Validation of the Bluebelle Wound Healing questionnaire (WHQ) for assessment of surgical site infection in primary surgical wounds after hospital discharge

Background Accurate assessment of surgical‐site infection (SSI) is crucial for surveillance and research. Self‐reporting patient measures are needed because current SSI tools are limited for assessing patients after leaving hospital. The Bluebelle Wound Healing Questionnaire (WHQ) was developed for patient or observer completion; this study tested its acceptability, scale structure, reliability and validity in patients with closed primary wounds after abdominal surgery. Methods Patients completed the WHQ (self‐assessment) within 30 days after leaving hospital and returned it by post. Healthcare professionals completed the WHQ (observer assessment) by telephone or face‐to‐face. Questionnaire response rates and patient acceptability were assessed. Factor analysis and Cronbach's α examined scale structure and internal consistency. Test–retest and self‐ versus observer reliability assessments were performed. Sensitivity and specificity for SSI discrimination against a face‐to‐face reference diagnosis (using Centers for Disease Control and Prevention criteria) were examined. Results Some 561 of 792 self‐assessments (70·8 per cent) and 597 of 791 observer assessments (75·5 per cent) were completed, with few missing data or problems reported. Data supported a single‐scale structure with strong internal consistency (α greater than 0·8). Reliability between test–retest and self‐ versus observer assessments was good (κ 0·6 or above for the majority of items). Sensitivity and specificity for SSI discrimination was high (area under the receiver operating characteristic (ROC) curve 0·91). Conclusion The Bluebelle WHQ is acceptable, reliable and valid with a single‐scale structure for postdischarge patient or observer assessment of SSI in closed primary wounds

Rationale and design of BISTRO: a randomized controlled trial to determine whether bioimpedance spectroscopy guided fluid management maintains residual kidney function in incident haemodialysis patients

Background: Preserved residual kidney function (RKF) and normal fluid status are associated with better patient outcomes in incident haemodialysis patients. The objective of this trial is to determine whether using bioimpedance technology in prescribing the optimal post-dialysis weight can reduce the rate of decline of RKF and potentially improve patient outcomes. Methods/Design: 516 patients commencing haemodialysis, aged >18 with RKF of > 3 ml/min/1.73 m2 or a urine volume >500 ml per day or per the shorter inter-dialytic period will be consented and enrolled into a pragmatic, open label, randomized controlled trial. The intervention is incorporation of bioimpedance spectroscopy (BI) determination of normally hydrated weight to set a post-dialysis target weight that limits volume depletion, compared to current standard practice. Clinicians and participants will be blinded to BI measures in the control group and a standardized record capturing management of fluid status will be used in all participants. Primary outcome is preservation of residual kidney function assessed as time to anuria (≤100 ml/day or ≤200 ml urine volume in the short inter-dialytic period). A sample size of 516 was based upon a cumulative incidence of 30% anuria in the control group and 20% in the treatment group and 11% competing risks (death, transplantation) over 10 months, with up to 2 years follow-up. Secondary outcomes include rate of decline in small solute clearance, significant adverse events, hospitalization, loss of vascular access, cardiovascular events and interventions, dialysis efficacy and safety, dialysis-related symptoms and quality of life. Economic evaluation will be carried out to determine the cost-effectiveness of the intervention. Analyses will be adjusted for patient characteristics and dialysis unit practice patterns relevant to fluid management. Discussion: This trial will establish the added value of undertaking BI measures to support clinical management of fluid status and establish the relationship between fluid status and preservation of residual kidney function in incident haemodialysis patients. Trial registration: ISCCTN Number: 11342007, completed 26/04/2016; NIHR Portfolio number: CPMS31766; Sponsor: Keele University Keywords: Fluid status, Body composition, Residual kidney function, Haemodialysis, Bioimpedance, Fluid management, Health economic

Measuring, valuing and including forgone childhood education and leisure time costs in economic evaluation : methods, challenges and the way forward

Economic evaluations carried out to inform the allocation of finite public funds ought to take into account all relevant costs and benefits. When such evaluations adopt a societal perspective, it is important that they include ‘time-related’ costs arising from productivity and leisure time losses due to receipt of care, ill health or both. For programmes that relate to children, similar costs arise from forgone time, though there is a distinct lack of insights into how such costs should be identified, measured and valued. We set out to explore how forgone time—including absence from formal education and childhood leisure time—can be estimated and incorporated into economic evaluations. To do so, we look at theories and approaches to time valuation proposed in different disciplines and we discuss their suitability for use in health economics research. We find that, while there is a sizeable literature on time valuation methods in education, labour and transportation economics, much of this is not directly applicable to economic evaluation of health care interventions for children. We identify gaps in existing methods and practice, we outline challenges in moving forwards and we provide a list of considerations aiming to assist researchers in deciding whether, and how, to include foregone time-related costs in economic evaluation

Bluebelle study (phase A) : a mixed-methods feasibility study to inform an RCT of surgical wound dressing strategies

Objectives Dressing primary surgical wounds is common, but the implications for surgical site infection (SSI) remain unknown. The Bluebelle study aimed to determine the feasibility of a randomised controlled trial (RCT) comparing ‘simple’, ‘complex’ or ‘no’ dressings on abdominal wounds, as prespecified in a funder's research brief. Bluebelle includes exploratory work (phase A) to inform a pilot version of the proposed RCT (phase B). Phase A aimed to investigate current dressing practices and perspectives on the proposed RCT, with a view to refining the forthcoming pilot. Design Mixed methods, including semi-structured interviews and document analysis. Setting 6 UK hospitals. Participants 51 patients and 92 clinical professionals from abdominal surgical specialities. Results Professionals had variable interpretations of what constitutes a ‘dressing’, particularly with respect to ‘glue’—a product listed under ‘wound-closure products’ in the British National Formulary, which some surgeons reportedly applied as a ‘wound covering’. Areas of ambiguity arising from interviews informed development of pragmatic definitions, including specification of conditions under which glue constituted a ‘dressing’. Professionals reported that ‘simple’ dressings were routinely used in practice, whereas ‘complex’ dressings were not. This raised questions about the relevance of comparison groups, prompting the design of a survey to determine the types/frequency of dressing use in abdominal surgery (reported elsewhere). This confirmed that complex dressings were rarely used, while ‘glue as a dressing’ was used relatively frequently. ‘Complex dressings’ were therefore substituted for ‘glue as a dressing’ (following an updated Cochrane review, which found insufficient evidence to determine the effectiveness of ‘glue as a dressing’). Patients and professionals acknowledged uncertainty around dressing use and SSI prevention, but felt dressings may serve practical and/or psychological benefits. This steered development of additional outcome measures for the pilot. Conclusions Pre-trial qualitative research can highlight areas of ambiguity and inform new lines of enquiry in relation to prespecified research briefs, enabling adjustments to RCT design that enhance relevance to practice