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Health Technology Assessment... 2003To evaluate the effectiveness and cost-effectiveness of tension-free vaginal tape (TVT) in comparison with the standard surgical interventions currently used. (Comparative Study)
Comparative Study Review
OBJECTIVES
To evaluate the effectiveness and cost-effectiveness of tension-free vaginal tape (TVT) in comparison with the standard surgical interventions currently used.
DATA SOURCES
Literature searches were carried out on electronic databases and websites for data covering the period 1966--2002. Other sources included references lists of relevant articles; selected experts in the field; abstracts of a limited number of conference proceedings titles; and the Internet.
REVIEW METHODS
A systematic review of studies including comparisons of TVT with any of the comparators was conducted. Alternative treatments considered were abdominal retropubic colposuspension (including both open and laparoscopic colposuspension), traditional suburethral sling procedures and injectable agents (periurethral bulking agents). The identified studies were critically appraised and their results summarised. A Markov model comparing TVT with the comparators was developed using the results of the review of effectiveness and data on resource use and costs from previously conducted studies. The Markov model was used to estimate costs and quality-adjusted life-years for up to 10 years following surgery and it incorporated a probabilistic analysis and also sensitivity analysis around key assumptions of the model.
RESULTS
Based on limited data from direct comparisons with TVT and from systematic reviews, laparoscopic colposuspension and traditional slings have broadly similar cure rates to TVT and open colposuspension, whereas injectable agents appear to have lower cure rates. TVT is less invasive than colposuspension and traditional sling procedures, and is also usually performed under regional or local anaesthesia. The principal operative complication is bladder perforation. There are currently no randomised controlled trial (RCT) data beyond 2 years post-surgery, and long-term effects are therefore currently not known reliably. TVT was more likely to be considered cost-effective compared with the other surgical procedures. Increasing the absolute probability of cure following TVT reduced the likelihood that TVT would be considered cost-effective.
CONCLUSIONS
The long-term performance of TVT in terms of both continence and unanticipated adverse effects is not known reliably at the moment. Despite relatively few robust comparative data, it appears that in the short to medium term TVT's effectiveness approaches that of alternative procedures currently available, and is of lower cost. As TVT is a less invasive procedure, it is possible that some women who would currently be managed non-surgically will be considered eligible for TVT. Increased adoption of TVT will require additional surgeons proficient in the technique. It is likely that some of the higher rates of complications, e.g. bladder perforation, reported for TVT are associated with a 'learning curve'. Appropriate training will therefore be needed for surgeons new to the operation, in respect of both the technical aspects of the procedure and the choice of women suitable for the operation. Further research suggestions include unbiased assessments of longer term performance from follow-up of controlled trials or population-based registries; more data from methodologically sound RCTs using standard outcome measures; a surveillance system to detect longer term complications, if any, associated with the use of tape; and rigorous evaluation before extending the use of TVT to women who are currently managed non-surgically.
Topics: Colposcopy; Cost-Benefit Analysis; Female; Humans; Prostheses and Implants; Quality-Adjusted Life Years; Technology Assessment, Biomedical; Treatment Outcome; Urethra; Urinary Incontinence, Stress; Urologic Surgical Procedures; Vagina
PubMed: 13678548
DOI: 10.3310/hta7210 -
JBJS Essential Surgical Techniques 2020The most common type of rotator cuff lesion is a tear of the supraspinatus tendon, with arthroscopic rotator cuff repair representing an established treatment option....
The most common type of rotator cuff lesion is a tear of the supraspinatus tendon, with arthroscopic rotator cuff repair representing an established treatment option. Several double-row techniques have been described to achieve complete coverage of the rotator cuff footprint. Among these is the bridging, double-row, transosseous-equivalent rotator cuff repair, which has become one of the most popular techniques for its maximized contact area and initial fixation strength. However, medial cuff failure is a common complication following this procedure. To reduce medial strangulation and overall surgical time, all-knotless anchor repair has been introduced as an alternative technique. The arthroscopic knotless, bridging, double-row, transosseous-equivalent technique is performed with the patient in the beach-chair position via lateral operative and viewing portals. A medial row of suture anchors is placed in the usual fashion. The tendon is then perforated twice per anchor with use of a suture-passer device, after which the suture limbs are bridged over the tendon and fixed in a lateral row of anchors. Excellent functional outcomes as well as satisfaction in >90% of patients have been reported with the supraspinatus knotted double-row, bridging, transosseous-equivalent repair. No significant differences have been reported for clinical results and tendon integrity on magnetic resonance imaging when comparing knot-tying and knotless double-row transosseous-equivalent rotator cuff repair; however, the rate of medial cuff failure was lower among knotless procedures. The major steps of the procedure, which are demonstrated in this video article, include (1) diagnostic arthroscopy; (2) supraspinatus tear visualization and debridement; (3) decortication of the footprint on the greater tuberosity; (4) placement of the medial row of anchors loaded with nonabsorbable suture tape; (5) separate suture passage of each limb, perforating the tendon with use of a suture passer; (6) fixation of the tape in the lateral row of anchors, creating a bridging configuration; and (7) anterolateral acromioplasty with use of an arthroscopic burr. Complications are rare following this procedure. As postoperative rehabilitation is essential for tendon healing, the operative arm should be placed in an abduction brace for 6 weeks, with only passive mobilization.
PubMed: 34055468
DOI: 10.2106/JBJS.ST.19.00021 -
SecurAcath for Securing Peripherally Inserted Central Catheters: A NICE Medical Technology Guidance.Applied Health Economics and Health... Dec 2018Central venous catheters are commonly used to deliver therapies and to monitor patients, and require securing at the point of percutaneous entry to avoid dislodgement.... (Review)
Review
Central venous catheters are commonly used to deliver therapies and to monitor patients, and require securing at the point of percutaneous entry to avoid dislodgement. SecurAcath is a catheter securement device designed for central venous catheters. The National Institute for Health and Care Excellence, as a part of its Medical Technologies Evaluation Programme, selected this device for evaluation and invited the manufacturer, Interrad Medical, to submit clinical and economic evidence. The King's Technology Evaluation Centre, an External Assessment Centre commissioned by the National Institute for Health and Care Excellence, independently critiqued the manufacturer's submissions. The External Assessment Centre found a lack of evidence comparing SecurAcath with alternative approaches to securement (StatLock, suturing, tape securement), with one unpublished randomised controlled trial providing the strongest evidence. The External Assessment Centre conducted a new systematic review and meta-analysis and concluded that there is some evidence indicating the non-inferiority of SecurAcath compared to StatLock. The External Assessment Centre considered the manufacturer's economic model to be appropriate but made revisions to some parameters and noted significant heterogeneity in the included studies. The revised model indicated that StatLock was more cost effective than SecurAcath for catheter indwell times of up to 5 days; however, for medium- and long-term indwell times, SecurAcath was the most cost-effective option. The National Institute for Health and Care Excellence Medical Technologies Guidance MTG 34, issued in June 2017, recommended the adoption of SecurAcath for securing peripherally inserted central catheters within the National Health Service in England.
Topics: Catheterization, Central Venous; Central Venous Catheters; Humans; Practice Guidelines as Topic; Technology Assessment, Biomedical
PubMed: 30123950
DOI: 10.1007/s40258-018-0427-1 -
European Endodontic Journal Jan 2023According to the American Association of Endodontists (AAE), 22 million endodontic procedures have been performed annually. Root canal treatment is needed to prevent...
OBJECTIVE
According to the American Association of Endodontists (AAE), 22 million endodontic procedures have been performed annually. Root canal treatment is needed to prevent infection and restore function when a tooth is severely infected or decayed. This procedure is the only way to preserve the natural tooth and avoid artificial replacement (implant, denture, etc.). The current study aims to develop an electrochemical reamer (EC-Reamer or EC-R) that can help to disinfect the canal system and thus improve the success rate of root canal treatment.
METHODS
The COMSOL Multiphysics software was utilized to simulate the experimental setup and confirm the current flow in the electrolyte. The benchtop experimental approach follows a specific electrochemical protocol, (i) open circuit potential to monitor the electrochemical stabilization and (ii) potentiostatic scan at -9.0 V as the treatment stage. Identification of feasible reference electrode (RE) and insulation material for the exploratory benchtop studies considered platinum (Pt) and gold (Au) wire as the REs and hot melt adhesive (HMA) and liquid tape as the insulation materials. The antimicrobial effects of EC-R were analysed using Enterococcus faecalis (E. faecalis). One-way ANOVA with the Tukey post hoc test and a significance level of P<0.05 is used to compare the groups with an experimental duration of 60 seconds.
RESULTS
The findings showed that magnitude and current fluctuations created by Pt wire are promising when compared to Au wire, while Pt-HMA pair is chosen considering Pt's good electrochemical inertness and HMA's easy handling, availability, and non-hazardous features. The use of potentiostatic duration of 1 s and 3 s resulted in >99.99% E. faecalis reduction. Duration at 5 s and above resulted in a total bacterial kill. Statistical analysis confirmed a significant difference among the groups tested with commercial and custom-built potentiostats.
CONCLUSION
The outcome provided preliminary data for developing an EC-R prototype to enhance the antimicrobial effect during root canal treatment potentially. (EEJ-2022-01-04).
Topics: Dental Pulp Cavity; Root Canal Therapy; Anti-Infective Agents
PubMed: 36748441
DOI: 10.14744/eej.2022.86094 -
Biomedical Engineering Letters Mar 2024This research was conducted to apply polyimide tape, which has the advantages of low price ans strong adhesive strength, to the neural electrode process. In addition, to...
This research was conducted to apply polyimide tape, which has the advantages of low price ans strong adhesive strength, to the neural electrode process. In addition, to maximize the low-cost characteristics, a fabrication process based on UV laser patterning rather than a photolithography process was introduced. The fabrication process started by attaching the gold sheet on the conductive double-sided tape without being torn or crushed. Then, the gold sheet and the double-sided tape were patterned together using UV laser. The patterned layer was transferred to the single-side polyimide tape. For insulation layer, electrode site opened single-sided polyimide tape was prepared. Polydimethylsiloxane was used as an adhesion layer, and alignment between electrode sites and opening sites was processed manually. The minimum line width achieved through the proposed fabrication process was approximately 100 m, and the sheet resistance of the conductive layer was 0.635 /sq. Measured cathodal charge storage capacity was 0.72 mC/cm and impedance at 1 kHz was 4.07 k/cm. Validation of fabricated electrode was confirmed by conducting 30 days accelerated soak test, flexibility test, adhesion test and ex vivo stimulation test. The novel flexible neural electrodes based on single-sided polyimide tape and UV laser patterned gold sheet was fabricated successfully. Conventional neural electrode fabrication processes based on polyimide substrate has a disadvantages such as long fabrication time, expensive costs, and probability of delamination between layers. However, the novel fabrication process which we introduced can overcome many shortcomings of existing processes, and offers great advantages such as simplicity of fabrication, inexpensiveness, flexibility and long-term reliability.
PubMed: 38374899
DOI: 10.1007/s13534-023-00345-0 -
International Journal of Pharmaceutics Oct 2020Leishmaniasis is a neglected disease presenting cutaneous, mucosal and visceral forms and affecting an estimated 12 million mostly low-income people. Treatment of...
Leishmaniasis is a neglected disease presenting cutaneous, mucosal and visceral forms and affecting an estimated 12 million mostly low-income people. Treatment of cutaneous leishmaniasis (CL) is recommended to expedite healing, reduce risk of scarring, prevent parasite dissemination to other mucocutaneous (common with New World species) or visceral forms and reduce the chance of relapse, but remains an unmet need. Available treatments are painful, prolonged (>20 days) and require hospitalisation, which increases the cost of therapy. Here we present the development of optimised topical self-nanoemulsifying drug delivery systems (SNEDDS) loaded with buparvaquone (BPQ, a hydroxynapthoquinone from the open Malaria Box) for the treatment of CL from New World species. The administration of topical BPQ-SNEDDS gels for 7 days resulted in a reduction of parasite load of 99.989 ± 0.019% similar to the decrease achieved with intralesionally administered Glucantime® (99.873 ± 0.204%) in a L. amazonensis BALB/c model. In vivo efficacy was supported by ex vivo permeability and in vivo tape stripping studies. BPQ-SNEDDS and their hydrogels demonstrated linear flux across non-infected CD-1 mouse skin ex vivo of 182.4 ± 63.0 μg cm h and 57.6 ± 10.8 μg cm h respectively localising BPQ within the skin in clinically effective concentrations (227.0 ± 45.9 μg and 103.8 ± 33.8 μg) respectively. These levels are therapeutic as BPQ-SNEDDS and their gels showed nanomolar in vitro efficacy against L. amazonensis and L. braziliensis amastigotes with excellent selectivity index toward parasites versus murine macrophages. In vivo tape stripping experiments indicated localisation of BPQ within the stratum corneum and dermis. Histology studies confirmed the reduction of parasitism and indicated healing in animals treated with BPQ-SNEDDS hydrogels. These results highlight the potential clinical capability of nano-enabled BPQ hydrogels towards a non-invasive treatment for CL.
Topics: Animals; Antiprotozoal Agents; Hydrogels; Leishmaniasis, Cutaneous; Mice; Mice, Inbred BALB C; Naphthoquinones
PubMed: 32777535
DOI: 10.1016/j.ijpharm.2020.119734 -
Allergy Jan 2021Skin biopsies promote our understanding of atopic dermatitis/AD pathomechanisms in infants/toddlers with early-onset AD, but are not feasible in pediatric populations....
BACKGROUND
Skin biopsies promote our understanding of atopic dermatitis/AD pathomechanisms in infants/toddlers with early-onset AD, but are not feasible in pediatric populations. Tape strips are an emerging, minimally invasive alternative, but global transcriptomic profiling in early pediatric AD is lacking. We aimed to provide global lesional and nonlesional skin profiles of infants/toddlers with recent-onset, moderate-to-severe AD using tape strips.
METHODS
Sixteen tape strips were collected for RNA-seq profiling from 19 infants/toddlers (<5 years old; lesional and nonlesional) with early-onset moderate-to-severe AD (≤6 months) and 17 healthy controls.
RESULTS
We identified 1829 differentially expressed genes/DEGs in lesional AD and 662 DEGs in nonlesional AD, vs healthy skin (fold-change ≥2, FDR <0.05), with 100% sample recovery. Both lesional and nonlesional skin showed significant dysregulations of Th2 (CCL17 and IL4R) and Th22/Th17 (IL36G, CCL20, and S100As)-related genes, largely lacking significant Th1-skewing. Significant down-regulation of terminal differentiation (FLG and FLG2), lipid synthesis/metabolism (ELOVL3 and FA2H), and tight junction (CLDN8) genes were primarily seen in lesional AD. Significant negative correlations were identified between Th2 measures and epidermal barrier gene-subsets and individual genes (FLG with IL-4R and CCL17; r < -0.4, P < .05). Significant correlations were also identified between clinical measures (body surface area/BSA, pruritus ADQ, and transepidermal water loss/TEWL) with immune and barrier mRNAs in lesional and/or nonlesional AD (FLG/FLG2 with TEWL; r < -0.4, P < .05).
CONCLUSION
RNA-seq profiling using tape strips in early-onset pediatric AD captures immune and barrier alterations in both lesional and nonlesional skin. Tape strips provide insight into disease pathomechanisms and cutaneous disease activity.
Topics: Child; Child, Preschool; Dermatitis, Atopic; Eczema; Epidermis; Filaggrin Proteins; Gene Expression Profiling; Humans; Skin
PubMed: 32639640
DOI: 10.1111/all.14490 -
Orthopaedic Journal of Sports Medicine Mar 2022Despite the increasing prevalence of tape-type sutures, whether internal knotless anchors can consistently affix tape-type sutures has not been thoroughly investigated.
BACKGROUND
Despite the increasing prevalence of tape-type sutures, whether internal knotless anchors can consistently affix tape-type sutures has not been thoroughly investigated.
PURPOSE
To evaluate whether substituting tape-type sutures for conventional sutures influences the suture-holding strength of internal knotless anchors.
STUDY DESIGN
Controlled laboratory study. Level of evidence, 5.
METHODS
A total of 3 internal knotless anchors were tested: a spiral core clamping anchor (Footprint Ultra PK), a winged clamping anchor (PopLok), and a spooling anchor (ReelX STT). Four constructs were compared for each type of anchor, with the anchor double or quadruple loaded with tape-type sutures or conventional sutures. The testing protocol comprised preloading suture tension to 10 N; cyclic loading, in which tension increased in increments of 10 N from 10 to 90 N; and a load-to-failure stage set at a speed of 0.5 mm/s. The clinical failure load (CFL) was defined as suture slippage of ≥3 mm. Also, 1-way analysis of variance and power analysis were used to compare the CFLs of the constructs.
RESULTS
For the quadruple-loaded spiral core clamping anchors, a significant reduction in CFLs was seen with conventional sutures over tape-type sutures (138.10 ± 4.73 vs 80.00 ± 12.25 N, respectively; < .001). This reduction was not observed under the double-loaded condition (conventional vs tape type: 76.00 ± 5.48 vs 80.00 ± 10.00 N, respectively). Substitution of the suture materials did not significantly reduce the CFLs for the winged clamping anchors (conventional vs tape type: 40.00 ± 10.00 vs 30.00 ± 7.07 N for double loaded, respectively, and 64.00 ± 13.41 vs 50.00 ± 10.00 N for quadruple loaded, respectively) or the spooling anchors (conventional vs tape type: 62.00 ± 19.23 vs 56.32 ± 20.20N for double loaded, respectively, and 72.00 ± 21.68 vs 84.00 ± 13.42 N for quadruple loaded, respectively).
CONCLUSION
Substituting tape-type sutures for conventional sutures increased the CFLs of some internal knotless anchors. With specific suture-anchor combinations, quadruple-loaded conventional suture anchors had CFLs higher than those of double-loaded conventional suture anchors.
CLINICAL RELEVANCE
When multiple tape-type sutures are used in conjunction with a clamping anchor, clinicians should note a possible reduction in CFLs and resultant early suture slippage.
PubMed: 35356310
DOI: 10.1177/23259671211072523 -
Journal of Applied Microbiology Feb 2017Pyoderma, predominantly associated with Staphylococcus pseudintermedius, is a common skin infection of dogs that typically requires long-lasting treatments, complicated...
AIMS
Pyoderma, predominantly associated with Staphylococcus pseudintermedius, is a common skin infection of dogs that typically requires long-lasting treatments, complicated by increasing antimicrobial resistance. To investigate new treatment strategies, we aimed at establishing a dog model of pyoderma that closely mimics the natural disease.
METHODS AND RESULTS
We inoculated six laboratory beagles with a methicillin-susceptible strain of S. pseudintermedius. One millilitre of approximately 10 , 10 , 10 CFU per ml was topically applied onto clipped and tape stripped area of dog skin, which was then treated with a dermaroller (microneedle size: 500 μm) immediately after administration. Dogs were monitored daily, suspect pustules were cultured for S. pseudintermedius and evaluated by cytological and histopathological methods. After 24 h, all dogs developed papules and pustules at all three bacterial inoculation sites, which worsened over the next 48 h. Cytological samples of all skin lesions revealed neutrophils with intracellular cocci. Histopathology confirmed subcorneal neutrophilic pustular dermatitis with intralesional cocci and acantholytic keratinocytes, consistent with superficial pyoderma. Staphylococcus pseudintermedius was isolated from pustules of all dogs and confirmed to be the inoculating strain. The results were replicated in all dogs after a wash out period of 6 weeks.
CONCLUSIONS
These data demonstrate the feasibility of establishing a dog model of pyoderma.
SIGNIFICANCE AND IMPACT OF THE STUDY
The new model can be used to evaluate novel prevention and treatment options for canine pyoderma.
Topics: Animals; Dermatitis, Atopic; Disease Models, Animal; Dog Diseases; Dogs; Female; Male; Pyoderma; Staphylococcal Skin Infections; Staphylococcus
PubMed: 27891724
DOI: 10.1111/jam.13362 -
Journal of Applied Clinical Medical... Jul 2017To investigate the inter- and intra-fraction motion associated with the use of a low-cost tape immobilization technique as an alternative to thermoplastic immobilization...
To investigate the inter- and intra-fraction motion associated with the use of a low-cost tape immobilization technique as an alternative to thermoplastic immobilization masks for whole-brain treatments. The results of this study may be of interest to clinical staff with severely limited resources (e.g., in low-income countries) and also when treating patients who cannot tolerate standard immobilization masks. Setup reproducibility of eight healthy volunteers was assessed for two different immobilization techniques. (a) One strip of tape was placed across the volunteer's forehead and attached to the sides of the treatment table. (b) A second strip was added to the first, under the chin, and secured to the table above the volunteer's head. After initial positioning, anterior and lateral photographs were acquired. Volunteers were positioned five times with each technique to allow calculation of inter-fraction reproducibility measurements. To estimate intra-fraction reproducibility, 5-minute anterior and lateral videos were taken for each technique per volunteer. An in-house software was used to analyze the photos and videos to assess setup reproducibility. The maximum intra-fraction displacement for all volunteers was 2.8 mm. Intra-fraction motion increased with time on table. The maximum inter-fraction range of positions for all volunteers was 5.4 mm. The magnitude of inter-fraction and intra-fraction motion found using the "1-strip" and "2-strip" tape immobilization techniques was comparable to motion restrictions provided by a thermoplastic mask for whole-brain radiotherapy. The results suggest that tape-based immobilization techniques represent an economical and useful alternative to the thermoplastic mask.
Topics: Cost-Benefit Analysis; Cranial Irradiation; Head; Healthy Volunteers; Humans; Immobilization; Masks; Reproducibility of Results
PubMed: 28585732
DOI: 10.1002/acm2.12101