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Clinical and cost effectiveness of booklet based vestibular rehabilitation for chronic dizziness in primary care: single blind, parallel group, pragmatic, randomised controlled trial.

Yardley L, Barker F, Muller I, Turner D, Kirby S, Mullee M, Morris A, Little P - BMJ (2012)

Bottom Line: At 12 weeks, scores on the vertigo symptom scale in the telephone support group did not differ significantly from those in the routine care group (adjusted mean difference -1.79 (95% confidence interval -3.69 to 0.11), P=0.064).At one year, both intervention groups improved significantly relative to routine care (telephone support -2.52 (-4.52 to -0.51), P=0.014; booklet only -2.43 (-4.27 to -0.60), P=0.010).Analysis of cost effectiveness acceptability curves showed that both interventions were highly cost effective; at very low QALY values, the booklet only approach was most likely to be cost effective, but the approach with additional telephone support was most likely to be cost effective at QALY values more than £1200 (€1488; $1932).

View Article: PubMed Central - PubMed

Affiliation: Faculty of Human and Social Sciences, University of Southampton, Southampton SO17 1BJ, UK. L.Yardley@soton.ac.uk

ABSTRACT

Objective: To determine the clinical and cost effectiveness of booklet based vestibular rehabilitation with and without telephone support for chronic dizziness, compared with routine care.

Design: Single blind, parallel group, pragmatic, randomised controlled trial.

Setting: 35 general practices across southern England between October 2008 and January 2011.

Participants: Patients aged 18 years or over with chronic dizziness (mean duration >five years) not attributable to non-vestibular causes (confirmed by general practitioner) and that could be aggravated by head movement (confirmed by patient).

Interventions: Participants randomly allocated to receive routine medical care, booklet based vestibular rehabilitation only, or booklet based vestibular rehabilitation with telephone support. For the booklet approach, participants received self management booklets providing comprehensive advice on undertaking vestibular rehabilitation exercises at home daily for up to 12 weeks and using cognitive behavioural techniques to promote positive beliefs and treatment adherence. Participants receiving telephone support were offered up to three brief sessions of structured support from a vestibular therapist.

Main outcome measures: Vertigo symptom scale-short form and total healthcare costs related to dizziness per quality adjusted life year (QALY).

Results: Of 337 randomised participants, 276 (82%) completed all clinical measures at the primary endpoint, 12 weeks, and 263 (78%) at one year follow-up. We analysed clinical effectiveness by intention to treat, using analysis of covariance to compare groups after intervention, controlling for baseline symptom scores. At 12 weeks, scores on the vertigo symptom scale in the telephone support group did not differ significantly from those in the routine care group (adjusted mean difference -1.79 (95% confidence interval -3.69 to 0.11), P=0.064). At one year, both intervention groups improved significantly relative to routine care (telephone support -2.52 (-4.52 to -0.51), P=0.014; booklet only -2.43 (-4.27 to -0.60), P=0.010). Analysis of cost effectiveness acceptability curves showed that both interventions were highly cost effective; at very low QALY values, the booklet only approach was most likely to be cost effective, but the approach with additional telephone support was most likely to be cost effective at QALY values more than £1200 (€1488; $1932). Using the booklet approach with telephone support, five (three to 12) patients would need to be treated for one patient to report subjective improvement at one year.

Conclusions: Booklet based vestibular rehabilitation for chronic dizziness is a simple and cost effective means of improving patient reported outcomes in primary care.

Trial registration: ClinicalTrials.gov NCT00732797.

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Related in: MedlinePlus

Fig 1 CONSORT diagram showing patient flow through trial
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fig1: Fig 1 CONSORT diagram showing patient flow through trial

Mentions: We randomised 337 participants; at 12 weeks, 276 (82%) completed the follow-up questionnaires, including the primary outcome, whereas 312 (93%) responded to the single item assessment of subjective improvement. At 12 months, 263 participants (78%) completed the follow-up questionnaires and 295 (88%) completed the single item assessment of subjective improvement. Figure 1 shows the flow of participants through the trial. Of 5223 patients sent an invitation, most did not reply (3250, 62%); but among the 1461 (28%) who completed the refusal slip, a large proportion (1052, 72%) reported that they were no longer dizzy. Table 1 shows participants’ characteristics at baseline. We observed baseline differences between study groups for sex, age when leaving school, duration of dizziness, consultation with a healthcare professional in the past year, and number of patients exceeding the threshold for anxiety or depression on the hospital anxiety and depression scale. As a result, we adjusted our sensitivity analysis for these imbalances (web appendix).


Clinical and cost effectiveness of booklet based vestibular rehabilitation for chronic dizziness in primary care: single blind, parallel group, pragmatic, randomised controlled trial.

Yardley L, Barker F, Muller I, Turner D, Kirby S, Mullee M, Morris A, Little P - BMJ (2012)

Fig 1 CONSORT diagram showing patient flow through trial
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC3368486&req=5

fig1: Fig 1 CONSORT diagram showing patient flow through trial
Mentions: We randomised 337 participants; at 12 weeks, 276 (82%) completed the follow-up questionnaires, including the primary outcome, whereas 312 (93%) responded to the single item assessment of subjective improvement. At 12 months, 263 participants (78%) completed the follow-up questionnaires and 295 (88%) completed the single item assessment of subjective improvement. Figure 1 shows the flow of participants through the trial. Of 5223 patients sent an invitation, most did not reply (3250, 62%); but among the 1461 (28%) who completed the refusal slip, a large proportion (1052, 72%) reported that they were no longer dizzy. Table 1 shows participants’ characteristics at baseline. We observed baseline differences between study groups for sex, age when leaving school, duration of dizziness, consultation with a healthcare professional in the past year, and number of patients exceeding the threshold for anxiety or depression on the hospital anxiety and depression scale. As a result, we adjusted our sensitivity analysis for these imbalances (web appendix).

Bottom Line: At 12 weeks, scores on the vertigo symptom scale in the telephone support group did not differ significantly from those in the routine care group (adjusted mean difference -1.79 (95% confidence interval -3.69 to 0.11), P=0.064).At one year, both intervention groups improved significantly relative to routine care (telephone support -2.52 (-4.52 to -0.51), P=0.014; booklet only -2.43 (-4.27 to -0.60), P=0.010).Analysis of cost effectiveness acceptability curves showed that both interventions were highly cost effective; at very low QALY values, the booklet only approach was most likely to be cost effective, but the approach with additional telephone support was most likely to be cost effective at QALY values more than £1200 (€1488; $1932).

View Article: PubMed Central - PubMed

Affiliation: Faculty of Human and Social Sciences, University of Southampton, Southampton SO17 1BJ, UK. L.Yardley@soton.ac.uk

ABSTRACT

Objective: To determine the clinical and cost effectiveness of booklet based vestibular rehabilitation with and without telephone support for chronic dizziness, compared with routine care.

Design: Single blind, parallel group, pragmatic, randomised controlled trial.

Setting: 35 general practices across southern England between October 2008 and January 2011.

Participants: Patients aged 18 years or over with chronic dizziness (mean duration >five years) not attributable to non-vestibular causes (confirmed by general practitioner) and that could be aggravated by head movement (confirmed by patient).

Interventions: Participants randomly allocated to receive routine medical care, booklet based vestibular rehabilitation only, or booklet based vestibular rehabilitation with telephone support. For the booklet approach, participants received self management booklets providing comprehensive advice on undertaking vestibular rehabilitation exercises at home daily for up to 12 weeks and using cognitive behavioural techniques to promote positive beliefs and treatment adherence. Participants receiving telephone support were offered up to three brief sessions of structured support from a vestibular therapist.

Main outcome measures: Vertigo symptom scale-short form and total healthcare costs related to dizziness per quality adjusted life year (QALY).

Results: Of 337 randomised participants, 276 (82%) completed all clinical measures at the primary endpoint, 12 weeks, and 263 (78%) at one year follow-up. We analysed clinical effectiveness by intention to treat, using analysis of covariance to compare groups after intervention, controlling for baseline symptom scores. At 12 weeks, scores on the vertigo symptom scale in the telephone support group did not differ significantly from those in the routine care group (adjusted mean difference -1.79 (95% confidence interval -3.69 to 0.11), P=0.064). At one year, both intervention groups improved significantly relative to routine care (telephone support -2.52 (-4.52 to -0.51), P=0.014; booklet only -2.43 (-4.27 to -0.60), P=0.010). Analysis of cost effectiveness acceptability curves showed that both interventions were highly cost effective; at very low QALY values, the booklet only approach was most likely to be cost effective, but the approach with additional telephone support was most likely to be cost effective at QALY values more than £1200 (€1488; $1932). Using the booklet approach with telephone support, five (three to 12) patients would need to be treated for one patient to report subjective improvement at one year.

Conclusions: Booklet based vestibular rehabilitation for chronic dizziness is a simple and cost effective means of improving patient reported outcomes in primary care.

Trial registration: ClinicalTrials.gov NCT00732797.

Show MeSH
Related in: MedlinePlus