Nicky A Cullum

Publications (160) View all

• Article: Economic evaluation of a randomized controlled trial of ultrasound therapy for hard-to-heal venous leg ulcers.

  L-H Chuang, M O Soares, J M Watson, J M Bland, N Cullum, C Iglesias, A R Kang'ombe, D Torgerson, E A Nelson
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  ABSTRACT: A pragmatic, multicentre randomized controlled trial (VenUS III) was conducted to determine whether low-dose ultrasound therapy increased the healing rate of hard-to-heal leg ulcers. This study was a cost-effectiveness analysis of the trial data. Cost-effectiveness and cost-utility analyses were conducted alongside the VenUS III trial, in which patients were randomly allocated to either ultrasound treatment administered weekly for 12 weeks along with standard care, or standard care alone. The time horizon was 12 months and based on the UK National Health Service (NHS) perspective. The base-case analysis showed that ultrasound therapy added to standard care was likely to be more costly and provide no extra benefit over standard care alone. Individuals who received ultrasound treatment plus standard care took a mean of 14.7 (95 per cent confidence interval - 32.7 to 56.8) days longer to heal, had 0.009 (-0.042 to 0.024) fewer quality-adjusted life years and had higher treatment costs by £ 197.88 (-35.19 to 420.32). Based on these point estimates, ultrasound therapy plus standard care for leg ulcers was dominated by standard care alone. The analysis of uncertainty showed that this treatment strategy is unlikely to be cost-effective. Ultrasound treatment was not cost-effective for hard-to-heal leg ulcers and should not be recommended for adoption in the NHS.
  British Journal of Surgery 04/2011; 98(8):1099-106. · 4.61 Impact Factor
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  Article: VenUS III: a randomised controlled trial of therapeutic ultrasound in the management of venous leg ulcers.

  J M Watson, A R Kang'ombe, M O Soares, L-H Chuang, G Worthy, J M Bland, C Iglesias, N Cullum, D Torgerson, E A Nelson
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  ABSTRACT: To compare the clinical effectiveness and cost-effectiveness of low-dose ultrasound delivered in conjunction with standard care against standard care alone in the treatment of hard-to-heal venous ulcers. A multicentre, pragmatic, two-armed randomised controlled trial with an economic evaluation. Community nurse services; community leg ulcer clinics; hospital outpatient leg ulcer clinics, among both urban and rural settings in England, Scotland, Northern Ireland and Ireland. Patients with a venous leg ulcer of > 6 months' duration or > 5 cm2 and an ankle-brachial pressure index of ≥ 0.8. In total, 337 patients were recruited to the study. Participants in the intervention group received low-dose ultrasound (0.5 W/cm2) delivered at 1 MHz, pulsed pattern of 1 : 4, applied to periulcer skin (via a water-based contact gel) weekly for up to 12 weeks alongside standard care. Standard care consisted of low-adherent dressings and compression therapy, renewed as recommended by the patient's nurse and modified if required to reflect changes in ulcer and skin condition. The output of the ultrasound machines was checked every 3 months to confirm intervention fidelity. The primary end point was time to healing of the largest eligible ulcer (reference ulcer). Secondary outcomes were time to healing of all ulcers, proportion of patients healed, percentage and absolute change in ulcer size, proportion of time patients were ulcer free, cost of treatments, health-related quality of life (HRQoL), adverse events, withdrawal and loss to follow-up. There was a small, and statistically not significant, difference in the median time to complete ulcer healing of all ulcers in favour of standard care [median 328 days, 95% confidence interval (CI) 235 days, inestimable] compared with ultrasound (median 365 days, 95% CI 224 days, inestimable). There was no difference between groups in the proportion of patients with ulcers healed at 12 months (72/168 in ultrasound vs 78/169 standard care), nor in the change in ulcer size at 4 weeks. There was no evidence of a difference in recurrence of healed ulcers. There was no difference in HRQoL [measured using the Short Form questionnaire-12 items (SF-12)] between the two groups. There were more adverse events with ultrasound than with standard care. Ultrasound therapy as an adjuvant to standard care was found not to be a cost-effective treatment when compared with standard care. The mean cost of ultrasound was £197.88 (bias-corrected 95% CI -£35.19 to £420.32) higher than standard care per participant per year. There was a significant relationship between ulcer healing and area and duration at baseline. In addition, those centres with high recruitment rates had the highest healing rates. Low-dose ultrasound, delivered weekly during dressing changes, added to the package of current best practice (dressings, compression therapy) did not increase ulcer healing rates, affect quality of life (QoL) or reduce recurrence. It was associated with higher costs and more adverse events. There is no evidence that adding low-dose ultrasound to standard care for 'hard-to-heal' ulcers aids healing, improves QoL or reduces recurrence. It increases costs and adverse events. The relationship between ulcer healing rates and patient recruitment is worthy of further study. Current Controlled Trials ISRCTN21175670. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 13. See the HTA programme website for further project information.
  Health technology assessment (Winchester, England). 03/2011; 15(13):1-192.
• Article: Coping style and depression influence the healing of diabetic foot ulcers: observational and mechanistic evidence.

  K Vedhara, J N V Miles, M A Wetherell, K Dawe, A Searle, D Tallon, N Cullum, A Day, C Dayan, N Drake, P Price, J Tarlton, J Weinman, R Campbell
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  ABSTRACT: Experimental evidence suggests that the healing of diabetic foot ulcers is affected by psychosocial factors such as distress. We examined this proposal in a prospective study, in which we considered the role of psychological distress and coping style in the healing of diabetic foot ulcers over a 24 week period. We also explored the role of salivary cortisol and matrix metalloproteinases (MMPs) as potential mechanisms. For this prospective observational study we recruited 93 (68 men; mean age 60 years) patients with neuropathic or neuroischaemic diabetic foot ulcers from specialist podiatry clinics in secondary care. Clinical and demographic determinants of healing, psychological distress, coping, salivary cortisol and both MMP2 and MMP9 were assessed at baseline. Ulcers were assessed at baseline and at 6, 12 and 24 weeks post-baseline. The primary outcome was ulcer status at 24 weeks, i.e. healed vs not healed. After controlling for clinical and demographic determinants of healing, ulcer healing at 24 weeks was predicted by confrontation coping, but not by depression or anxiety. Patients with unhealed ulcers exhibited greater confrontation coping (model including depression: OR 0.809, 95% CI 0.704-0.929, p = 0.003; model including anxiety: OR 0.810, 95% CI 0.704-0.930, p = 0.003). However, change in ulcer size over the observation period was associated with depression only (p = 0.04, d = 0.31). Healed ulcers by 24 weeks were also associated with lower evening cortisol, higher precursor MMP2 and a greater cortisol awakening response. Confrontation coping and depression predict ulcer healing. Our preliminary enquiry into biological mechanisms suggests that cortisol and precursor MMP2 may underlie these relationships.
  Diabetologia 08/2010; 53(8):1590-8. · 6.81 Impact Factor
• Article: Reflections on the recommendations of the EWMA Patient Outcome Group document.

  R Ashby, J M Bland, N Cullum, J Dumville, J Hall, A Kang Ombe, M Madden, S O Meara, M Soares, D Torgerson, J Watson
  Journal of wound care 07/2010; 19(7):282-5.
• Article: Value of a modified clinical signs and symptoms of infection checklist for leg ulcer management.

  L A Dennis, J C Dumville, N Cullum, J M Bland
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  ABSTRACT: The aim of this study was to analyse the validity of a modified Clinical Signs and Symptoms Checklist used to measure infection in a sample of patients with a leg ulcer. Data from patients recruited to a randomized controlled trial evaluating larval therapy (VenUS II) were analysed using factor analysis to identify the underlying checklist structure. Linear regression analysis identified whether checklist items, patient characteristics and subjective judgement of infection could predict bacterial load. There were several redundant checklist items when implemented in this sample and items forming the scale had low internal consistency (alpha = 0.27). No clear structure to the checklist was detected, with only one underlying theme revealed which had low internal consistency (alpha = 0.45). Predictions of bacterial count were possible using the emerged theme, some checklist items and ankle circumference, but not using clinicians' subjective judgement alone (P = 0.315). The modified Clinical Signs and Symptoms Checklist does not currently represent a valid tool to measure infection in leg ulcers. Some checklist items may predict bacterial load and may be better than subjective judgement alone.
  British Journal of Surgery 03/2010; 97(5):664-70. · 4.61 Impact Factor