Anne-Maree Keenan

Effect of the early use of the anti–tumor necrosis factor adalimumab on the prevention of job loss in patients with early rheumatoid arthritis

OBJECTIVE To compare work disability and job loss in early rheumatoid arthritis (RA) patients receiving adalimumab plus methotrexate (adalimumab + MTX) versus MTX alone. METHODS In this multicenter, randomized, controlled trial, patients with RA for <2 years who had never taken MTX and who self-reported work impairment were randomized to adalimumab + MTX or placebo + MTX for 56 weeks. Primary outcome was job loss of any cause and/or imminent job loss at or after week 16. Secondary outcomes included disease activity, function (Health Assessment Questionnaire [HAQ] score), and RA quality of life (RAQoL) questionnaire score. Work was evaluated with work diaries and the RA Work Instability Scale. RESULTS Although job loss during the 56-week study was significantly lower with adalimumab + MTX (14 of 75 patients) compared with MTX alone (29 of 73 patients; P=0.005), the primary end point was not met (12 of 75 versus 20 of 73 patients; P=0.092), likely owing to early drop out in the MTX group. There were significant improvements in American College of Rheumatology 20% response criteria, 28-joint Disease Activity Score, DeltaHAQ, DeltaRAQoL, and working time lost in the adalimumab + MTX group. Twenty-four serious adverse events were reported in 17 participants, with no differences between groups. CONCLUSION Adalimumab + MTX reduced job loss and improved productivity in early RA when compared with MTX alone, which supports the early use of anti-tumor necrosis factor therapy and suggests its cost efficacy.

Efficacy of foot orthoses. What does the literature tell us

This paper reviews the literature relating to foot orthoses, in particular foot orthoses that attempt to alter biomechanical function. Whilst few well-controlled studies have been performed, the findings from the available literature are generally positive. The authors provide an overview of this literature and then summarise the findings. The literature is categorised into six research outcome areas: (i) patient satisfaction, (ii) pain and deformity, (iii) plantar pressures, (iv) position and motion, (v) muscle activity, and (vi) oxygen consumption. In addition, the difficulties associated with researching foot orthoses are discussed.

Foot Type and Overuse Injury in Triathletes

Abnormal foot morphology has been suggested to contribute to overuse injuries in athletes. This study investigated the relationship between foot type and injury incidence in a large sample of competitive triathletes not wearing foot orthoses during a 6-month retrospective analysis and a 10-week prospective cohort study. Foot alignment was measured using the Foot Posture Index and the Valgus Index, and participants were assigned to supinated, pronated, and normal foot-type groups. Overall, 131 triathletes sustained 155 injuries during the study. Generally, foot type was not a major risk factor for injury; however, there was a fourfold increased risk of overuse injury during the competition season in athletes with a supinated foot type. The results of this study show that triathletes with a supinated foot type are more likely to sustain an overuse injury.

Remission induction comparing infliximab and high-dose intravenous steroid, followed by treat-to-target: a double-blind, randomised, controlled trial in new-onset, treatment-naive, rheumatoid arthritis (the IDEA study)

Objectives In disease modifying antirheumatic drug (DMARD)-naive early rheumatoid arthritis (RA), to compare the efficacy of methotrexate (MTX) and infliximab (IFX) with MTX and intravenous corticosteroid for remission induction. Methods In a 78-week multicentre randomised controlled trial, double-blinded to week 26, 112 treatment-naive RA patients (1987 American College of Rheumatology classification criteria) with disease activity score 44 (DAS44)>2.4 were randomised to MTX + IFX or MTX + single dose intravenous methylprednisolone 250 mg. A treat-to-target approach was used with treatment escalation if DAS44>2.4. In the IFX group, IFX was discontinued for sustained remission (DAS44<1.6 for 6 months). The primary outcome was change in modified total Sharp-van der Heijde score (mTSS) at week 50. Results The mean changes in mTSS score at week 50 in the IFX and intravenous steroid groups were 1.20 units and 2.81 units, respectively (adjusted difference (95% CI) −1.45 (−3.35 to 0.45); p=0.132). Radiographic non-progression (mTSS<2.0) occurred in 81% vs 71% (OR 1.77 (0.56 to 5.61); p=0.328). DAS44 remission was achieved at week 50 in 49% and 36% (OR 2.13 (0.91 to 5.00); p=0.082), and at week 78 in 48% and 50% (OR 1.12 (0.47 to 2.68); p=0.792). Exploratory analyses suggested higher DAS28 remission at week 6 and less ultrasound synovitis at week 50 in the IFX group. Of the IFX group, 25% (14/55) achieved sustained remission and stopped IFX. No substantive differences in adverse events were seen. Conclusions In DMARD-naive early RA patients, initial therapy with MTX+high-dose intravenous steroid resulted in good disease control with little structural damage. MTX+IFX was not statistically superior to MTX+intravenous steroid when combined with a treat-to-target approach.

Contoured, prefabricated foot orthoses demonstrate comparable mechanical properties to contoured, customised foot orthoses: a plantar pressure study

BackgroundFoot orthoses have been demonstrated to be effective in the management of a range of conditions, but there is debate as to the benefits of customised foot orthoses over less expensive, prefabricated devices.MethodsIn a randomised, cross-over trial, 15 flat-footed participants aged between 18 and 45 years were provided with semi-rigid, customised orthoses and semi-rigid, contoured, prefabricated orthoses. Pressures and forces were measured using an in-shoe system with subjects wearing shoes alone, wearing customised orthoses, and again when wearing contoured prefabricated orthoses. Two weeks acclimatisation was included between cross-over of therapy. Repeated measures ANOVA models with post-hoc, pair-wise comparisons were used to test for differences.ResultsWhen compared to wearing shoes alone, wearing either the customised orthoses or the prefabricated orthoses was associated with increases in force and force time integrals in the midfoot region. Peak and maximum mean pressure and pressure-time, and force-time integrals were reduced in both the medial and lateral forefoot. There were, however, no significant differences between the customised orthoses and the prefabricated orthoses at any site.ConclusionThere was a similar change in loading with both the semi-rigid customised and the semi-rigid prefabricated orthoses when compared to the shoe alone condition. However, while customised devices offered minor differences over prefabricated orthoses in some variables, these were not statistically significant. The results suggest that there may be only minor differences in the effects on plantar pressures between the customised and the less expensive prefabricated orthoses tested in this study, however further research is warranted.

Foot orthosis prescription habits of Australian and New Zealand podiatric physicians.

This research project investigated the orthotic prescription habits of podiatric physicians in Australia and New Zealand. A 23-item questionnaire was distributed to all members of the Australian Podiatry Association and the New Zealand Society of Podiatrists. When asked what type of foot orthoses they prescribe most often, 72% of respondents reported functional foot orthoses; the next most common response was prefabricated orthoses (12%). A typical prescription for functional foot orthoses consisted of a modified Root style orthosis, balanced to the neutral calcaneal stance position, with the shell made from polypropylene and an ethyl vinyl acetate (EVA) rearfoot post applied. The majority of podiatric physicians surveyed used a commercial orthotic laboratory to fabricate their orthoses. However, New Zealand respondents were three times more likely to prescribe prefabricated foot orthoses, and males were twice as likely as females to manufacture the orthoses themselves rather than use a commercial orthotic laboratory.

An evaluation of two foot-specific, health-related quality-of-life measuring instruments

In the past decade, health-related quality-of-life (HRQoL) assessment has become an important tool to measure change as a result of treatment in clinical trials. The aim of this project was to compare and contrast two foot-specific HRQoL questionnaires: the Foot Function Index (FFI) and the Foot Health Status Questionnaire (FHSQ). To assist in this process, a quasi-experimental trial was performed to evaluate the effectiveness of foot orthoses in improving HRQoL in people suffering from plantar fasciitis. The results from this study found that the FFI is generally less responsive to change, particularly in the domain of Activity Limitation. Nevertheless, significant improvements were found for two out of the three domains (Pain and Disability, but not Activity Limitation) for the FFI, as well as the overall score of FFI. In contrast, all four domains (Pain, Function, Footwear and General Foot Health) of the FHSQ showed significant improvement. Our experience with the questionnaires also revealed that certain questions in the Activity Limitation domain of the FFI can lead to inconsistent scoring, thus casting doubts over the suitability of this domain for use with patients with plantar fasciitis. Therefore, the FHSQ has several advantages when evaluating HRQoL in patients being treated with foot orthoses for plantar fasciitis, and should be viewed as the preferred questionnaire.

Development and validation of a needs-based quality of life instrument for osteoarthritis.

OBJECTIVE To develop and validate a disease-specific quality of life (QOL) measure for osteoarthritis (OA), the OAQoL, using the needs-based conceptual model. METHODS In the first phase of this study, in-depth, semistructured interviews were conducted with 44 OA patients to explore the issues associated with impact of OA and to derive items for a draft OAQoL questionnaire. In phase 2, 17 OA patients were interviewed on the relevance, clarity, and ease of completion of the measure in structured interviews. In phase 3, the draft questionnaire was mailed to 635 patients to test the psychometric properties of the questionnaire using Rasch analysis. Test-retest assessment of the revised questionnaire was performed in phase 4 by mailing the questionnaire to an additional 201 participants, with a second questionnaire repeated 2 weeks later. RESULTS A 38-item draft measure was devised during phase 1 and mailed in phase 2. Rasch analysis of the draft questionnaire (n = 259) indicated initial misfit, which was rectified with the removal of 13 problematic items (chi(2)[75] = 83.602, P = 0.232). For the test-retest assessment (n = 60), 3 additional items were removed, leaving a 22-item OAQoL that demonstrated good fit to the Rasch model (chi(2)[44] = 44.559, P = 0.533) with excellent test-retest correlation (rho = 0.925, P < 0.001; z = -0.06, P = 0.995). CONCLUSION The OAQoL is a simple and easy to use 22-item unidimensional questionnaire developed specifically to assess the impact of OA on QOL. The measure has been developed as a true patient-based questionnaire and demonstrates good psychometric properties, including test-retest reliability.

Effectiveness of Low-Dye Taping for the Short-term Management of Plantar Fasciitis

Low-Dye taping is often used as a short-term treatment for plantar fasciitis. We evaluated the short-term effectiveness of low-Dye taping in relieving pain associated with plantar fasciitis. In this comparative study conducted at a university-based clinic, 65 participants with plantar fasciitis who received low-Dye taping for 3 to 5 days were compared with 40 participants who did not receive taping. Pain before and after treatment was measured using a visual analog pain scale. Analysis of the data was by the intention-to-treat principle, and a linear regression approach to analysis of covariance was used to compare effects. The visual analog pain scale score improved by a mean of 20 mm (from 44 to 24 mm) in the taping group and worsened by a mean of 6 mm (from 51 to 57 mm) in the control group. The analysis of covariance-adjusted difference in therapeutic effect favored the taping group by 31.7 mm (95% confidence interval, 23.6-39.9 mm) and was statistically significant (t = 7.71). In the short term, low-Dye taping significantly reduces the pain associated with plantar fasciitis. These findings are the first quantitative results to demonstrate the significant therapeutic effect of this treatment modality in relieving the symptoms associated with plantar fasciitis.

Wound healing and infection in nail matrix phenolization wounds. Does topical medication make a difference

After nail matrix ablation using phenolization, a medicated wound dressing (10% povidone iodine), an amorphous hydrogel dressing (Intrasite Gel), and a control dressing (paraffin gauze) were evaluated. Forty-two participants, randomly divided into three dressing groups, were evaluated. Healing time did not differ between the 10% povidone iodine (33 days), amorphous hydrogel (33 days), and the control dressing (34 days). For all groups, the clinical infection rate was lower than in previous studies, and there was no clinical difference between groups (one infection in the povidone iodine and control groups; none in the amorphous hydrogel group). However, in the amorphous hydrogel group, other complications, such as hypergranulation, were more likely. This investigation indicated that medicated or hydrogel dressings did not enhance the rate of healing or decrease infection rates.