Jennifer White

Background: Proximal phalanx finger shaft fractures are common and can impair hand function. There is controversy, but no high-quality evidence, on how they are best treated. We compared the clinical and cost-effectiveness of surgery versus non-surgical splint treatment. Objective: The primary objective was to compare hand function following surgical fixation with hand function following non-surgical splint treatment using the Hand Health Profile of the Patient Evaluation Measure at 6 months post randomisation. Design: Pragmatic multicentre, parallel superiority randomised (1 : 1) trial. Setting: Twenty-four acute hospitals in the United Kingdom National Health Service. Participants: Patients ≥ 16 years with one or more proximal phalanx shaft fracture(s), which can be treated via either surgery or non-surgical splint treatment. Patients with intra-articular, base-metaphyseal, neck, open proximal phalanx fractures, injury ≥ 14 days or unable to adhere to trial procedures/complete questionnaires were excluded. Interventions: Surgery was any mode of surgical fixation that was considered as appropriate by the treating specialist. Non-surgical splint treatment consisted of any technique/material used in routine care, which may involve manipulation of the fracture with analgesia or local anaesthetic, and subsequent bracing through an externally applied support, usually performed in a clinic or therapy room environment. Main outcome measures: The primary outcome measure was the Hand Health Profile of the Patient Evaluation Measure (possible range 11–77, higher scores indicate worst function). Measurements were collected at 6 weeks, 3, 6 and 12 months; 6 months was the primary outcome time point. The primary health outcome for economic evaluation was quality-adjusted life-years in accordance with National Institute for Health and Care Excellence guidelines. Results: Between 9 November 2020 and 2 February 2023, 113 participants were randomised to surgery ( n = 56) or non-surgical treatment ( n = 55); 2 were excluded. Participants were 60% male, with mean age of 38 years. Treatment arms were balanced. Fifty-three participants in the surgical and 46 in the non-surgical group were included in the primary analysis. At 6 months, the mean Patient Evaluation Measure was 27.1 (standard deviation = 13.6, n = 48) in the surgical group and 25 (standard deviation 12.4, n = 41) in the non-surgical group, with no clinically important difference between groups (adjusted difference in means for surgery vs. non-surgical groups 3, 95% confidence interval −1.6 to 7.7). There were no differences at 6 weeks and 3 months. There were more complications in the surgery group. Surgery was more expensive, resulting in an incremental cost-effectiveness ratio of £39,686 per quality-adjusted life-year, with a 3.2% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £20,000. Conclusions: This study supports the conclusion that surgery does not restore better hand function than non-surgical treatment. Surgery results in additional complications and is more expensive. Limitations: We were unable to further determine if surgery is worse than splint or if the two treatments are equivalent, because of slow recruitment and the smaller than the planned sample size. Future work: Research should be directed towards further comparisons of treatments for common hand fractures. Funding: This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR127292.

Background: Education and advice is provided for tinnitus management in all UK audiology clinics. Sound therapy, including provision of hearing aids may be offered, but this is often dependent on a clinician’s decision rather than UK policy. This inconsistent management reflects a lack of evidence around the effectiveness of hearing aids for tinnitus. This open-label, two-arm multicentre randomised controlled feasibility trial gathered data around recruitment, acceptability and outcome assessments to determine the feasibility of conducting a large randomised controlled trial investigating the effectiveness of hearing aids for tinnitus management. Methods: Adults referred to audiology for tinnitus, with an aidable hearing loss were recruited at five UK audiology clinics. They were randomised 1:1 to either education and advice (treatment as usual (TAU), n = 41) or TAU plus hearing aids (n = 42). Outcomes were collected by questionnaires 12 weeks after randomisation. After participation, interviews were conducted with a subset of both participants and clinicians from each trial centre. Results: Eighty three participants from five sites were randomised. Non-aidable hearing loss was the main reason for ineligibility to participate in the trial reported by the sites. Seventy three percent of participants returned the 12-week questionnaires, with return rates by site ranging from 61 to 100%. Fifteen out of 33 participants (45%) reported using hearing aids for the clinician-recommended time, or longer, during the day. The Tinnitus Functional Index (TFI) was the outcome measure most responsive to change. The majority of participants also agreed it was relevant to their tinnitus and hearing loss. Qualitative data demonstrated that the trial was acceptable to participants. Feedback from clinicians revealed a potential lack of equipoise. It also highlighted the differences in referral and treatment pathways between departments and differences in audiometric criteria for fitting hearing aids. Health economic measures were well completed for those returned. No change in health-related quality of life was observed. Costs were higher in the intervention arm, but self-reports of healthcare service use indicated participant confusion in treatment pathways. Conclusions: This feasibility trial is the first step towards obtaining high quality evidence to determine potential clinical effectiveness and cost effectiveness of hearing aids for tinnitus versus usual care. A definitive trial was deemed to be feasible, with some modifications based on feasibility findings and using the TFI as the primary outcome. This trial was funded by the National Institute for Health Research, Research for Patient Benefit Programme (PB-PG-0816–20,014) and registered with ISRCTN (ISRCTN14218416).

Background: The HI-Light Trial demonstrated that for active, limited vitiligo, combination treatment with potent topical corticosteroid (TCS) and handheld narrowband ultraviolet B offers a better treatment response than potent TCS alone. However, it is unclear how to implement these findings.Aim: We sought to answer three questions: (i) Can combination treatment be used safely and effectively by people with vitiligo?; (ii) Should combination treatment be made available as routine clinical care?; and (iii) Can combination treatment be integrated within current healthcare provision?Methods: This was a mixed-methods process evaluation, including semi-structured interviews with a purposive sample of trial participants, structured interviews with commissioners, and an online survey and focus groups with trial staff. Transcripts were coded by framework analysis, with thematic development by multiple researchers.Results: Participants found individual treatments easy to use, but the combination treatment was complicated and required nurse support. Both participants and site investigators felt that combination treatment should be made available, although commissioners were less certain. There was support for the development of services offering combination treatment, although this might not be prioritized above treatment for other conditions. A ‘mixed economy’ model was suggested, involving patients purchasing their own devices, although concerns regarding the safe use of treatments mean that training, monitoring and ongoing support are essential. The need for medical physics support may mean that a regional service is more practical.Conclusion: Combination treatment should be made available for people seeking treatment for vitiligo, but services require partnership with medical physics and ongoing training and support for patients.

Background: Systematic reviews suggest that narrowband ultraviolet B light combined with treatments such as topical corticosteroids may be more effective than monotherapy for vitiligo.Objective: To explore the clinical effectiveness and cost-effectiveness of topical corticosteroid monotherapy compared with (1) hand-held narrowband ultraviolet B light monotherapy and (2) hand-held narrowband ultraviolet B light/topical corticosteroid combination treatment for localised vitiligo.Design: Pragmatic, three-arm, randomised controlled trial with 9 months of treatment and a 12-month follow-up.Setting: Sixteen UK hospitals – participants were recruited from primary and secondary care and the community.Participants: Adults and children (aged ≥ 5 years) with active non-segmental vitiligo affecting ≤ 10% of their body area.Interventions: Topical corticosteroids [mometasone furoate 0.1% (Elocon^®, Merck Sharp & Dohme Corp., Merck & Co., Inc., Whitehouse Station, NJ, USA) plus dummy narrowband ultraviolet B light]; narrowband ultraviolet B light (narrowband ultraviolet B light plus placebo topical corticosteroids); or combination (topical corticosteroids plus narrowband ultraviolet B light). Topical corticosteroids were applied once daily on alternate weeks and narrowband ultraviolet B light was administered every other day in escalating doses, with a dose adjustment for erythema. All treatments were home based.Main outcome measures: The primary outcome was self-assessed treatment success for a chosen target patch after 9 months of treatment (‘a lot less noticeable’ or ‘no longer noticeable’ on the Vitiligo Noticeability Scale). Secondary outcomes included blinded assessment of primary outcome and percentage repigmentation, onset and maintenance of treatment response, quality of life, side effects, treatment burden and cost-effectiveness (cost per additional successful treatment).Results: In total, 517 participants were randomised (adults,n = 398; and children,n = 119; 52% male; 57% paler skin types I–III, 43% darker skin types IV–VI). At the end of 9 months of treatment, 370 (72%) participants provided primary outcome data. The median percentage of narrowband ultraviolet B light treatment-days (actual/allocated) was 81% for topical corticosteroids, 77% for narrowband ultraviolet B light and 74% for combination groups; and for ointment was 79% for topical corticosteroids, 83% for narrowband ultraviolet B light and 77% for combination. Target patch location was head and neck (31%), hands and feet (32%), and rest of the body (37%). Target patch treatment ‘success’ was 20 out of 119 (17%) for topical corticosteroids, 27 out of 123 (22%) for narrowband ultraviolet B light and 34 out of 128 (27%) for combination. Combination treatment was superior to topical corticosteroids (adjusted risk difference 10.9%, 95% confidence interval 1.0% to 20.9%;p = 0.032; number needed to treat = 10). Narrowband ultraviolet B light was not superior to topical corticosteroids (adjusted risk difference 5.2%, 95% confidence interval –4.4% to 14.9%;p = 0.290; number needed to treat = 19). The secondary outcomes supported the primary analysis. Quality of life did not differ between the groups. Participants who adhered to the interventions for > 75% of the expected treatment protocol were more likely to achieve treatment success. Over 40% of participants had lost treatment response after 1 year with no treatment. Grade 3 or 4 erythema was experienced by 62 participants (12%) (three of whom were using the dummy) and transient skin thinning by 13 participants (2.5%) (two of whom were using the placebo). We observed no serious adverse treatment effects. For combination treatment compared with topical corticosteroids, the unadjusted incremental cost-effectiveness ratio was £2328.56 (adjusted £1932) per additional successful treatment (from an NHS perspective).Limitations: Relatively high loss to follow-up limits the interpretation of the trial findings, especially during the post-intervention follow-up phase.Conclusion: Hand-held narrowband ultraviolet B light plus topical corticosteroid combination treatment is superior to topical corticosteroids alone for treatment of localised vitiligo. Combination treatment was relatively safe and well tolerated, but was effective in around one-quarter of participants only. Whether or not combination treatment is cost-effective depends on how much decision-makers are willing to pay for the benefits observed.Future work: Development and testing of new vitiligo treatments with a greater treatment response and longer-lasting effects are needed.Trial registration: Current Controlled Trials ISRCTN17160087.Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 24, No. 64. See the NIHR Journals Library website for further project information.

Background Economic evidence for vitiligo treatments is absent. Objective To determine the cost‐effectiveness of (a) hand‐held narrowband‐UVB (NB‐UVB) and (b) combination of topical corticosteroid (TCS) and NB‐UVB compared to TCS for localised vitiligo. Methods Cost‐effectiveness analysis alongside a pragmatic, 3‐arm, placebo‐controlled RCT with 9 months’ treatment. 517 Adults and children (aged ≥5 years) with active vitiligo affecting <10% of skin recruited from secondary care and community were randomised 1:1:1 to receive: TCS; NB‐UVB; or both. Cost per successful treatment (measured on the Vitiligo Noticeability Scale) was estimated. Secondary cost‐utility analyses measured QALYs using the EQ‐5D‐5L for those aged 11+ and CHU‐9D for those aged 5 to <18. Results Mean (SD) cost per participant was £774.4 (83.71) for NB‐UVB, £813.38 (111.39) for combination treatment and £599.98 (96.18) for TCS. In analyses adjusted for age and target patch location, incremental difference in cost for combination treatment compared to TCS was £211.46 (95% CI 188.10 to 234.81), corresponding to a risk difference of 10.94% (Number‐Needed‐To‐Treat (NNT= 9). Incremental cost was £1,932.35 per successful treatment. The incremental difference in cost for NB‐UVB compared to TCS was £173.44 (95% CI 150.55 to 196.32) with a risk difference of 5.20% (NNT=19). Incremental cost was £3,335.74 per successful treatment. Conclusion Combination treatment, compared to TCS alone, has a lower incremental cost per additional successful treatment than NB‐UVB only. Combination treatment would be considered cost effective if decision makers are willing to pay £1,932 per additional treatment success.

Background: The most common management strategy for tinnitus provided in the UK audiology clinics is education and advice. This may also be combined with some form of sound therapy (e.g. digital hearing aids). While education and advice is generally provided by all clinics, there is a marked variability in provision of hearing aids that depends very much on clinical decisions. A recent Cochrane review concluded a lack of evidence to support or refute hearing aid use as a routine intervention for people with tinnitus and hearing loss. This lack of evidence is reflected in the inconsistency of tinnitus management in the UK. The aim of the HUSH trial is to determine the feasibility of conducting a definitive randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of hearing aids for adults with tinnitus and hearing loss. Methods: This is a multicentre randomised controlled feasibility trial. Up to 100 adults, aged 18 and over, presenting to 5 UK audiology clinics with a complaint of tinnitus and measurable hearing loss are being randomised to receive either (i) education and advice (treatment as usual) or (ii) education and advice with digital hearing aids. Feasibility outcomes are being collected around recruitment, retention, patient and healthcare professional acceptability and clinical outcome assessment. Outcomes are being collected via postal questionnaire at 12 weeks post baseline. A nested interview study will supplement clinical and other outcome data, providing a detailed understanding of participants’ and audiologists’ experience of both tinnitus management and the research processes. Discussion: This feasibility trial will help us to (i) determine if it is feasible to conduct a multicentre RCT comparing treatment as usual and treatment as usual plus digital hearing aids; (ii) optimise the design of a future definitive, multicentre RCT; and (iii) inform which outcome(s) is/are relevant for patients. This work presents an important first step in determining the effectiveness of hearing aids as a tinnitus management strategy. Trial registration: ISRCTN, ISRCTN14218416. Registered on 30 July 2018.

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