Is Etanercept 25 mg Once Weekly as Effective as 50 mg at Maintaining Response in Patients with Ankylosing Spondylitis? A Randomized Control Trial.

OBJECTIVE: To investigate, in a pilot randomized controlled trial, whether etanercept (ETN) 25 mg once weekly is effective at maintaining a clinical response in patients with ankylosing spondylitis (AS) who have responded to the standard 50 mg dose. METHODS: Adults with AS not responding to conventional therapies were prescribed ETN 50 mg once weekly for 6 months. Responders as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) were randomly assigned to taper to 25 mg once weekly or continue on 50 mg and followed for a further 6 months. The primary outcome measure was maintenance of a 50% reduction in the BASDAI or fall in BASDAI by ≥ 2 units and a ≥ 2-unit reduction in BASDAI spinal pain as measured on a 10-point visual analog scale at 6 months postrandomization. RESULTS: Of 89 patients assessed for eligibility, 59 were enrolled; 47 (80%) had sufficient clinical response and were eligible for randomization, 24 were assigned to continue receiving ETN 50 mg, and 23 to taper to 25 mg. After 6 months, 20 (83%) of the 50 mg arm maintained clinical response compared with 12 (52%) of the 25 mg arm (a difference of -31%, 95% CI -58% - -5%). CONCLUSION: Although this pilot study demonstrates that treatment with ETN 25 mg was less effective at maintaining treatment response in the stepdown phase, 52% of participants maintained treatment response. Future research should address which patients are suitable for tapering.

Evaluation of the effectiveness of manual chest physiotherapy techniques on quality of life at six months post exacerbation of COPD (MATREX): a randomised controlled equivalence trial.

BACKGROUND: Manual chest physiotherapy (MCP) techniques involving chest percussion, vibration, and shaking have long been used in the treatment of respiratory conditions. However, methodological limitations in existing research have led to a state of clinical equipoise with respect to this treatment. Thus, for patients hospitalised with an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), clinical preference tends to dictate whether MCP is given to assist with sputum clearance. We standardised the delivery of MCP and assessed its effectiveness on disease-specific quality of life. METHODS: In this randomised, controlled trial powered for equivalence, 526 patients hospitalised with acute COPD exacerbation were enrolled from four centres in the UK. Patients were allocated to receive MCP plus advice on airway clearance or advice on chest clearance alone. The primary outcome was a COPD specific quality of life measure, the Saint Georges Respiratory Questionnaire (SGRQ) at six months post randomisation. Analyses were by intention to treat (ITT). This study was registered, ISRCTN13825248. RESULTS: All patients were included in the analyses, of which 372 (71%) provided evaluable data for the primary outcome. An effect size of 0·3 standard deviations in SGRQ score was specified as the threshold for superiority. The ITT analyses showed no significant difference in SGRQ for patients who did, or did not receive MCP (95% CI -0·14 to 0·19). CONCLUSIONS: These data do not lend support to the routine use of MCP in the management of acute exacerbation of COPD. However, this does not mean that MCP is of no therapeutic value to COPD patients in specific circumstances.

Findings from the MATREX study: a treatment protocol for the delivery of manual chest therapy in respiratory care.

BACKGROUND: One of the difficulties in comparing the numerous studies on manual chest therapy (MCT) is the wide variety of techniques used and terms employed to describe the intervention. This lack of consistency in therapeutic approach and the absence of defined tools for evaluation have led to a continued air of skepticism about its true value. This paper presents a treatment protocol used in a large randomized controlled trial examining the efficacy and cost effectiveness of MCT for patients hospitalized with exacerbations of COPD. METHODS: Consensus development meetings with key physical therapists were held to identify the essential elements of MCT, address potential areas of ambiguity, and provide a set of clear parameters within which treatment would be based and recorded. This iterative approach resulted in a treatment protocol that combined best clinical practice with the research evidence available to date. RESULTS: In the Management of Exacerbations of COPD (MATREX) trial, 658 sessions of MCT were delivered by physical therapists over a 3 year period. A high level of adherence to the treatment protocol was seen for all but one of the protocol elements. CONCLUSIONS: With respect to the essential elements of MCT, the treatment protocol used in the MATREX trial offers sufficient flexibility to the therapist, while being robust enough to maintain clinical trial integrity. The level of adherence by therapists indicates its professional acceptability with respect to delivering and evaluating this therapy.

A Depression Recognition and Treatment package for families living with Stroke (DepReT-Stroke): study protocol for a randomised controlled trial.

BACKGROUND: Depression occurs in up to 50% of patients after stroke and limits rehabilitation and recovery. Mood disorders are also highly prevalent in carers; their mental health intertwined with the physical and mental wellbeing of the person they are caring for. We argue that working with families, rather than patients alone may improve the treatment of depression in both patients and their carers enhancing the mental wellbeing and quality of life of both. METHODS: A single blind cluster randomised controlled trial to evaluate whether families after stroke who are treated with the Depression Recognition and Treatment package (DepReT-Stroke) in addition to treatment as usual (TAU) show improved mental well being compared to those families who receive only TAU. We aim to recruit one hundred and twenty-six families (63 in each group). The DepReT-Stroke intervention will help families to consider the various treatment options for depression, make choices about which are likely to fit best with their lives and support them in the use of self-help therapies (e.g. computerised Cognitive Behavioural Therapy or exercise). An essential component of the DepReT-Stroke package will be to help people adhere to their chosen treatment(s). The primary outcome will be the Mental Component Subscale of the SF-36 assessed at baseline and again six months post intervention. Effectiveness of the intervention will be determined using analysis of co-variance; comparing the mean change in MCS scores from baseline to six months follow-up adjusting for the clustering effects of baseline scores and family. An economic evaluation of the intervention will help us determine whether the intervention represents a cost-effective use of resources. DISCUSSION: Depression both for patients and their carers is common after stroke. Our Depression Recognition and Treatment package (DepReT-stroke) may help clinicians be more effective at detecting and managing a common co-morbidity that limits rehabilitation and recovery. TRIAL REGISTRATION: ISRCTN: ISRCTN32451749 Research Ethics Committee Reference Number: 10/H0310/23 Grant Reference Number: (NIHR) PB-PG-0808-17056.

Serum transferrin receptor status of healthy adult Arabs.

Several studies have provided reference ranges for the concentration of serum transferrin receptor (sTfR) in various white populations, but there is a dearth of relevant reference sTfR data in non-whites. The aim of this investigation was to establish sTfR reference ranges and mean values for a healthy non-white Arab population that could be used also for Arabs worldwide. sTfR and serum ferritin concentrations were estimated by immunoassays and blood counts were determined by conventional methods. Analysis of the data of 114 volunteer Arab blood donors (91 male, 23 female) revealed a higher mean sTfR concentration in males of 22.6+/-8.1 nmol/L (range 10.9-38.7 nmol/L) compared to that in females of 18.7+/-4.4 nmol/L (range 10.7-25.8 nmol/L, p=0.001). There was no significant correlation of sTfR concentration with age, serum ferritin level, or blood haemoglobin level, but a strong inverse correlation was demonstrated with mean cell volume and mean cell haemoglobin of red cells. Iron-replete volunteer subjects with alpha-thalassaemia trait appear to have relatively high mean sTfR concentration. We recommend the use of gender-dependent sTfR reference values for Arabs.