Thopaz+ Portable Digital System for Managing Chest Drains: A NICE Medical Technology Guidance.

The Thopaz+ portable digital system was evaluated by the Medical Technologies Advisory Committee (MTAC) of the National Institute for Health and Care Excellence (NICE). The manufacturer, Medela, submitted a case for the adoption of Thopaz+ that was critiqued by Cedar, on behalf of NICE. Due to a lack of clinical evidence submitted by the manufacturer, Cedar carried out its own literature search. Clinical evidence showed that the use of Thopaz+ led to shorter drainage times, a shorter hospital stay, lower rates of chest drain re-insertion and higher patient satisfaction compared to conventional chest drainage when used in patients following pulmonary resection. One comparative study of the use of Thopaz+ in patients with spontaneous pneumothorax was identified and showed shorter drainage times and a shorter length of hospital stay compared to conventional drainage. No economic evidence was submitted by the manufacturer, but a simple decision tree model was included. The model was improved by Cedar and showed a cost saving of £111.33 per patient when Thopaz+ was used instead of conventional chest drainage in patients following pulmonary resection. Cedar also carried out a sub-group analysis of the use of Thopaz+ instead of conventional drainage in patients with pneumothorax where a cost saving of £550.90 was observed. The main cost driver for the model and sub-group analysis was length of stay. The sub-group analysis was based on a single comparative study. However, the MTAC received details of an unpublished audit of Thopaz+ which confirmed its efficacy in treating patients with pneumothorax. Thopaz+ received a positive recommendation in Medical Technologies Guidance 37.

Parafricta Bootees and Undergarments to Reduce Skin Breakdown in People with or at Risk of Pressure Ulcers: A NICE Medical Technologies Guidance.

As part of the development of the National Institute for Health and Care Excellence (NICE) Medical Technologies Guidance on Parafricta Bootees and Undergarments to reduce skin breakdown in people with, or at risk of, pressure ulcers, the manufacturer (APA Parafricta Ltd) submitted clinical and economic evidence, which was critically appraised by an External Assessment Centre (EAC) and subsequently used by the Medical Technologies Advisory Committee (MTAC) to develop recommendations for further research. The University of Birmingham and Brunel University, acting as a consortium, were commissioned to act as the EAC, independently appraising the submission. This article is an overview of the original evidence submitted, the EAC's findings and the final NICE guidance. Very little comparative evidence was submitted to demonstrate the effectiveness of Parafricta Bootees or Undergarments. The sponsor submitted a simple cost analysis to estimate the costs of using Parafricta in addition to current practice-in comparison with current practice alone-in hospital and community settings separately. The analysis took a National Health Service (NHS) perspective. The basis of the analysis was a previously published comparative study, which showed no statistical difference in average lengths of stay between patients who wore Parafricta Undergarments and Bootees, and those who did not. The economic model incorporated the costs of Parafricta but assumed shorter lengths of stay with Parafricta. The sponsor concluded that Parafricta was cost saving relative to the comparators. The EAC made amendments to the sponsor's analysis to correct for errors and to reflect alternative assumptions. Parafricta remained cost saving in most analyses, and the savings per prevalent case ranged from £757 in the hospital model to £3455 in the community model. All analyses were severely limited by the available data on effectiveness-in particular, a lack of good-quality comparative studies.

The TURis System for Transurethral Resection of the Prostate: A NICE Medical Technology Guidance.

The transurethral resection in saline (TURis) system was notified by the company Olympus Medical to the National Institute of Health and Care Excellence's (NICE's) Medical Technologies Evaluation Programme. Following selection for medical technologies guidance, the company developed a submission of clinical and economic evidence for evaluation. TURis is a bipolar surgical system for treating men with lower urinary tract symptoms due to benign prostatic enlargement. The comparator is any monopolar transurethral resection of the prostate (mTURP) system. Cedar, a collaboration between Cardiff and Vale University Health Board, Cardiff University and Swansea University in the UK, acted as an External Assessment Centre (EAC) for NICE to independently critique the company's submission of evidence. Eight randomised trials provided evidence for TURis, demonstrating efficacy equivalent to that of mTURP for improvement of symptoms. The company presented meta-analyses of key outcome measures, and the EAC made methodological modifications in response to the heterogeneity of the trial data. The EAC analysis found that TURis substantially reduced the relative risks of transurethral resection syndrome (relative risk 0.18 [95 % confidence interval 0.05-0.62]) and blood transfusion (relative risk 0.35 [95 % confidence interval 0.19-0.65]). The company provided a de novo economic model comparing TURis with mTURP. The EAC critiqued the model methodology and made modifications. This found TURis to be cost saving at £70.55 per case for existing Olympus customers and cost incurring at £19.80 per case for non-Olympus customers. When an additional scenario based on the only available data on readmission (due to any cause) from a single trial was modelled, the estimated cost saving per case was £375.02 for existing users of Olympus electrosurgery equipment and £284.66 per case when new Olympus equipment would need to be purchased. Meta-analysis of eight randomised trials showed that TURis is associated with a statistically significantly reduced risk of transurethral resection syndrome and a reduced need for blood transfusion-two factors that may drive cost saving for the National Health Service. The clinical data are equivocal as to whether TURis shortens the hospital stay. Limited data from a single study suggest that TURis may reduce the rate of readmission after surgery. The NICE guidance supports adoption of the TURis technology for performing transurethral resection of the prostate in men with lower urinary tract symptoms due to benign prostatic enlargement.

ViibraTip for Testing Vibration Perception to Detect Diabetic Peripheral Neuropathy: A NICE Medical Technology Guidance.

VibraTip™ was selected by the Medical Technologies Advisory Committee (MTAC) to undergo evaluation through the National Institute for Health and Care Excellence (NICE). VibraTip™ provides a vibratory stimulus for the purpose of detecting diabetic peripheral neuropathy (DPN) in patients with type 1 or 2 diabetes mellitus, and is intended to replace the current practice of using the 128 Hz tuning fork or 10 g monofilament (comparators). The sponsor (McCallan Medical) provided clinical and economic submissions which were evaluated by an External Assessment Centre (EAC). Of six diagnostic studies identified, the EAC considered that only one was directly relevant to the assessment. This study indicated VibraTip™ had a sensitivity of 0.79 (95 % CI 0.69-0.90) and specificity of 0.82 (95 % CI 0.74-0.90) for DPN using a neurothesiometer at 25 V as a reference standard. This was non-inferior to the comparators, but the sample size (n = 141) was too small to draw unequivocal conclusions and it is unclear how generalisable results were to clinical practice. The sponsor presented a de facto cost-minimisation model that in the base case showed minimal cost savings and, in sensitivity analysis which assumed diagnostic superiority of VibraTip™, showed large savings. The EAC appraised this model and concluded it was flawed as it was not evidence based and costs were likely to be unrealistic. The MTAC considered that the technology showed promise but decided the case for adoption was not proven, and therefore made a research recommendation as is reflected in NICE Medical Technology Guidance 22.

The geko™ electro-stimulation device for venous thromboembolism prophylaxis: a NICE medical technology guidance.

The geko™ device is a single-use, battery-powered, neuromuscular electrostimulation device that aims to reduce the risk of venous thromboembolism (VTE). The National Institute for Health and Care Excellence (NICE) selected the geko™ device for evaluation, and invited the manufacturer, Firstkind Ltd, to submit clinical and economic evidence. King's Technology Evaluation Centre, an External Assessment Centre (EAC) commissioned by the NICE, independently assessed the evidence submitted. The sponsor submitted evidence related to the geko™ device and, in addition, included studies of other related devices as further clinical evidence to support a link between increased blood flow and VTE prophylaxis. The EAC assessed this evidence, conducted its own systematic review and concluded that there is currently limited direct evidence that geko™ prevents VTE. The sponsor's cost model is based on the assumption that patients with an underlying VTE risk and subsequently treated with geko™ will experience a reduction in their baseline risk. The EAC assessed this cost model but questioned the validity of some model assumptions. Using the EACs revised cost model, the cost savings for geko™ prophylaxis against a 'no prophylaxis' strategy were estimated as £197 per patient. Following a second public consultation, taking into account a change in the original draft recommendations, the NICE medical technologies guidance MTG19 was issued in June 2014. This recommended the adoption of the geko™ for use in people with a high risk of VTE and when other mechanical/pharmacological methods of prophylaxis are impractical or contraindicated in selected patients within the National Health Service in England.

Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomised controlled trials.

OBJECTIVE: To determine the efficacy and tolerability of topical pimecrolimus and tacrolimus compared with other treatments for atopic dermatitis. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Electronic searches of the Cochrane Library, Medline, and Embase. STUDY SELECTION: Randomised controlled trials of topical pimecrolimus or tacrolimus reporting efficacy outcomes or tolerability. EFFICACY: investigators' global assessment of response; patients' global assessment of response; proportions of patients with flares of atopic dermatitis; and improvements in quality of life. Tolerability: overall rates of withdrawal; withdrawal due to adverse events; and proportions of patients with burning of the skin and skin infections. DATA SYNTHESIS: 4186 of 6897 participants in 25 randomised controlled trials received pimecrolimus or tacrolimus. Both drugs were significantly more effective than a vehicle control. Tacrolimus 0.1% was as effective as potent topical corticosteroids at three weeks and more effective than combined treatment with hydrocortisone butyrate 0.1% (potent used on trunk) plus hydrocortisone acetate 1% (weak used on face) at 12 weeks (number needed to treat (NNT) = 6). Tacrolimus 0.1% was also more effective than hydrocortisone acetate 1% (NNT = 4). In comparison, tacrolimus 0.03% was more effective than hydrocortisone acetate 1% (NNT = 5) but less effective than hydrocortisone butyrate 0.1% (NNT = -8). Direct comparisons of tacrolimus 0.03% and tacrolimus 0.1% consistently favoured the higher strength formulation, but efficacy differed significantly between the two strengths only after 12 weeks' treatment (rate ratio 0.80, 95% confidence interval 0.65 to 0.99). Pimecrolimus was far less effective than betamethasone valerate 0.1% (NNT = -3 at three weeks). Pimecrolimus and tacrolimus caused significantly more skin burning than topical corticosteroids. Rates of skin infections in any of the comparisons did not differ. CONCLUSIONS: Both topical pimecrolimus and topical tacrolimus are more effective than placebo treatments for atopic dermatitis, but in the absence of studies that show long term safety gains, any advantage over topical corticosteroids is unclear. Topical tacrolimus is similar to potent topical corticosteroids and may have a place for long term use in patients with resistant atopic dermatitis on sites where side effects from topical corticosteroids might develop quickly. In the absence of key comparisons with mild corticosteroids, the clinical need for topical pimecrolimus is unclear. The usefulness of either treatment in patients who have failed to respond adequately to topical corticosteroids is also unclear.

The effectiveness of GnRHa with and without 'add-back' therapy in treating premenstrual syndrome: a meta analysis.

OBJECTIVE: To determine the effectiveness of gonadotrophin-releasing hormone analogues (GnRHa) with and without hormonal add-back therapy in the management of premenstrual syndrome. DESIGN: Randomised controlled trials were identified by searching multiple databases. SETTING: Exeter and North Devon Research and Development Support Unit and Keele University Academic Unit of Obstetrics and Gynaecology. POPULATION: Women with pre-diagnosed premenstrual syndrome and/or premenstrual dysphoric disorder. METHODS: A meta-analysis of published randomised placebo-controlled trials assessing the use of GnRHa in the management of premenstrual syndrome. The standardised mean difference for each individual study and subsequently an overall standardised mean difference were calculated after demonstrating the consistency or homogeneity of the study results. MAIN OUTCOME MEASURES: Overall improvement in premenstrual symptomatology and effectiveness of GnRHa with additional hormonal add-back therapy were the main outcome measures assessed in this analysis. A secondary analysis was performed to assess the effectiveness of GnRHa in treating physical and emotional symptoms. RESULTS: Overall standardised mean difference for all trials that assessed the efficacy of GnRHa was -1.19 (95% confidence interval [CI] -1.88 to -0.51). The equivalent odds ratio was 8.66 (95% CI 2.52 to 30.26) in favour of GnRHa. GnRHa were more efficacious for physical than behavioural symptoms, although the difference was not statistically significant. The addition of hormonal add-back therapy to GnRHa did not appear to reduce the efficacy of GnRHa alone; standardised mean difference 0.12 (95% CI -0.35 to 0.58). CONCLUSIONS: GnRHa appear to be an effective treatment in the management of premenstrual syndrome. The addition of hormonal add-back therapy to reduce side effects does not reduce efficacy.

Menstrual symptometrics: a simple computer-aided method to quantify menstrual cycle disorders.

OBJECTIVE: To validate a menstrual symptometrics device that can quantify menstrual blood loss, dysmenorrhea, and the premenstrual syndrome against traditional methods of collecting data on symptoms. DESIGN: Validation study. SETTING: Academic research clinic for menstrual cycle disorders. PARTICIPANT(S): Women 18-50 years of age who presented with menstrual cycle disorders. Controls were recruited from lists of patients requesting sterilization and from hospital staff. INTERVENTION(S): Participants were asked to complete the menstrual symptometrics device and to record pain, blood loss, and premenstrual symptoms by using traditional methods (paper-based scales and the alkaline hematin method) for two cycles. MAIN OUTCOME MEASURE(S): Agreement between traditional methods of quantifying menstrual cycle disorders and data obtained from the menstrual symptometrics device, and acceptability of the latter technique to patients. RESULT(S): A high level of agreement was observed between the traditional methods and the menstrual symptometrics device in quantifying and diagnosing menorrhagia, dysmenorrhea, and the premenstrual syndrome. Most patients preferred the menstrual symptometrics device as a data collection tool. CONCLUSION(S): The menstrual symptometrics device is a rapid and accurate method of quantifying blood loss, pain, and premenstrual symptoms. It has a high level of patient acceptability and can provide instant pictorial feedback on symptoms for patients and clinicians.

Prescribing patterns in premenstrual syndrome.

BACKGROUND: Over 300 therapies have been proposed for premenstrual syndrome. To date there has been only one survey conducted in the UK of PMS treatments prescribed by GPs, a questionnaire-based study by the National Association of Premenstrual Syndrome in 1989. Since then, selective serotonin re-uptake inhibitors have been licensed for severe PMS/PMDD, and governmental recommendations to reduce the dosage of vitamin B6 (the first choice over-the-counter treatment for many women with PMS) have been made. This study investigates the annual rates of diagnoses and prescribing patterns for premenstrual syndrome (1993-1998) within a computerised general practitioner database. METHODS: Retrospective survey of prescribing data for premenstrual syndrome between 1993-1998 using the General Practice Research Database for the West Midlands Region which contains information on 282,600 female patients RESULTS: Overall the proportion of women with a prescription-linked diagnosis of premenstrual syndrome has halved over the five years. Progestogens including progesterone were the most commonly recorded treatment for premenstrual syndrome during the whole study period accounting for over 40% of all prescriptions. Selective serotonin-reuptake inhibitors accounted for only 2% of the prescriptions in 1993 but rose to over 16% by 1998, becoming the second most commonly recorded treatment. Vitamin B6 accounted for 22% of the prescriptions in 1993 but dropped markedly between 1997 and 1998 to 11%. CONCLUSIONS: This study shows a yearly decrease in the number of prescriptions linked to diagnoses for premenstrual syndrome. Progestogens including progesterone, is the most widely prescribed treatment for premenstrual syndrome despite the lack of evidence demonstrating their efficacy.