TITLE: Disposable Gloves for Use in Healthcare Settings: A Review of the Clinical and Cost-Effectiveness, Safety, and Guidelines

Transcription

1 TITLE: Disposable Gloves for Use in Healthcare Settings: A Review of the Clinical and Cost-Effectiveness, Safety, and Guidelines DATE: 16 September 2013 CONTEXT AND POLICY ISSUES Disposable glove use has been a norm in healthcare settings to provide barrier protection. To ensure that medical gloves meet the required criteria for exposure protection to users, approval by Health Canada is needed for licensing, and a policy for glove use was developed. 1-3 Advances in glove technology have permitted the introduction of different types of medical gloves, such as vinyl, nitrile, and neoprene gloves, that can reduce the risk of allergic reactions to latex gloves and may maintain fit, comfort and dexterity. 4,5 This review is an update of a previous Rapid Response review on the same topic in 2011, 6 and aims to compare the clinical effectiveness, safety, cost-effectiveness of different types of disposable gloves for use in healthcare settings, with particular interest in the comparison between vinyl and nitrile gloves. The evidence-based guidelines regarding the use of different types of disposable gloves will also be reviewed. RESEARCH QUESTIONS 1. What is the clinical effectiveness of different types of disposable gloves for use in healthcare settings? 2. What is the safety of different types of disposable gloves for use in healthcare settings? 3. What is the cost-effectiveness of different types of disposable gloves for use in healthcare settings? 4. What are the evidence-based guidelines regarding the use of different types of disposable gloves for use in healthcare settings? Disclaimer: The Rapid Response Service is an information service for those involved in planning and providing health care in Canada. Rapid responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. Rapid responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material and may contain material in which a third party owns copyright. This report may be used for the purposes of research or private study only. It may not be copied, posted on a web site, redistributed by or stored on an electronic system without the prior written permission of CADTH or applicable copyright owner. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners own terms and conditions.

2 KEY FINDINGS Findings from limited evidence showed there were no statistically significant differences in touch sensitivity or psychomotor performance between latex and nitrile gloves, despite a significant difference in subjective comfort rating. Facing a significant difference in manufacturer s suggested retail prices for different brand gloves and without evidence on the cost-effectiveness of different types of gloves for use in healthcare settings, the decision to purchase a specific type of glove at the present time should be a balance between glove comfort and glove costs. More evidence on the safety, clinical and cost-effectiveness of different disposable gloves in health care settings are needed. METHODS Literature Search Strategy A limited literature search was conducted on key resources including PubMed, The Cochrane Library (2013, Issue 7), University of York Centre for Reviews and Dissemination (CRD) databases, Canadian and major international health technology agencies, as well as a focused Internet search. No filters were applied to limit the retrieval by study type. Where possible, retrieval was limited to the human population. The search was also limited to English language documents published between April 1, 2011 and August 13, Internet links were provided, where available. Selection Criteria and Methods Table 1: Selection Criteria Population Intervention Comparator Outcomes Study Designs Nurses and healthcare workers Disposable gloves Including: vinyl, nitrile, latex, any others May be compared to each other (especially vinyl vs nitrite) Safety/barrier quality Effectiveness to prevent pathogen transmission Allergy potential Strength/durability Recommended duration for use Cost-effectiveness Health technology assessments, systematic reviews, meta-analyses, economic evaluations, and guidelines. If no systematic reviews were identified, randomized controlled trials (RCTs), and non-rcts were selected for inclusion. Exclusion Criteria Articles were excluded if they did not meet the selection criteria in Table 1, if they were not clinical studies (e.g. bench test studies), if they were published prior to April 2011, if they were Disposable Gloves: Clinical and Cost-Effectiveness 2

3 duplicate publications of the same study, or if they were referenced in a selected systematic review. Critical Appraisal of Individual Studies The quality of the included study was assessed using the Downs and Black checklist. 7 Numeric scores were not calculated. Instead, the strengths and limitations of the study are summarized and presented. SUMMARY OF EVIDENCE Quantity of Research Available The literature search yielded 182 citations. After screening of abstracts from the literature search and from other sources, 4 potentially relevant studies were selected for full-text review. One study was included in the review. 8 The PRISMA flowchart in Appendix 1 details the process of the study selection. Summary of Study Characteristics A detailed summary of the included study is provided in Appendix 2. Study design This report included one randomized controlled study that looked at the impact of different sterile glove brands on tactile and psychomotor performance of health care providers compared to no glove use. Population Forty-two anesthesia providers were enrolled and completed the included trial (nine anesthesiologists, seven nurse anesthetists, 20 residents and six student nurse anesthetists). Participants with known latex allergies or sensorimotor impairment were excluded. All participants had prior exposure to the gloves tested. Interventions and comparators Five glove brands were tested including three latex gloves and two nitrile gloves: 1) Molnlycke-Biogel latex, powder-free; 2) Ansell Sensi-Touch latex, powdered; 3) Cardinal-Esteem with Neu-Thera nitrile, latex-free, powder-free; 4) Ansell Perry Orthopaedic latex, powdered; and 5) Cardinal-Esteem Tru-Blu stretchy nitrile, non-sterile, latex-free, powder-free. With the exception of Cardinal-Esteem Tru-Blu gloves, all other types of gloves were sterile gloves. For each type of glove, glove use was compared with bare hands (no gloves). Disposable Gloves: Clinical and Cost-Effectiveness 3

4 Outcomes The study examined psychomotor performance (tactile, fine motor/dexterity, hand-eye coordination); glove comfort and performance. Participants underwent different validated psychomotor aptitude tests, namely Semmes- Weinstein Monofilament test (SWM), Crawford Small Parts Dexterity Test (CSPDT), and Purdue Pegboard Test (PPT). The SWM test assessed touch sensitivity; the CSPDT assessed fine motor dexterity and coordination; and the PPT assessed speed associated with hand-eye coordination. Participants performed each test 6 times, once with bare hands and once with each of five different glove types. Participants also rated the gloves based on their perception of performance and comfort, using a Likert scale. Summary of Critical Appraisal The included studies had hypotheses, main interventions and outcomes clearly described. The included studies are cross-over randomized in design. Estimates of random variability and actual probability values were provided. Participants were blinded to all results during testing. Limitations of the study are that its generalizability was limited to anesthesia providers, duration of glove use was not taken into account, bias of the participant on the type of glove tested, and the physician investigator was not blinded to the intervention studied. Details of the strengths and limitations of the included study are summarized in Appendix 3. Summary of Findings Main findings of included studies are summarized in detail in Appendix What is the clinical effectiveness of different types of disposable gloves for use in healthcare settings? The literature search identified one randomized controlled study that evaluated the performance of health care providers using different glove brands, and their costs. 8 Touch sensitivity All glove types had a statistically significant reduction in touch sensitivity in all nerve distributions compared with bare hands. Compared to non-sterile gloves, only latex Perry Orthopaedic gloves gave a statistically significant reduction in touch sensitivity within the radial and median nerve distributions. Fine motor dexterity and coordination There was no statistically significant difference between all glove types compared with bare hands. There was also no statistically significant difference between all sterile gloves compared to non-sterile gloves. Disposable Gloves: Clinical and Cost-Effectiveness 4

5 Speed associated with hand-eye coordination Only latex Perry Orthopaedic gloves had a statistically significant reduction in speed associated with hand-eye coordination compared with bare hands and compared with non-sterile gloves. Comfort There was a statistically significant difference among all glove types, with nitrile, latex-free, powder-free Cardinal-Esteem and latex, powder-free Biogel rated highest, and latex, powdered Perry Orthopaedic the lowest. Annual cost The manufacturer s suggested retail price for latex powder-free Biogel (US$18, no reference date provided) is three times the price for nitrile latex-free, powder-free Cardinal-Esteem, six times the price for latex, powdered Perry Orthopaedic, and 18 times the price for latex, powdered Sensi-Touch. For an institution that purchased 500,000 units per year, the annual cost for Biogel is US$9 million, while the costs for Esteem, Perry Orthopaedic and Sensi-Touch are US$2.8 million, US$1.5 million and US$0.5 million, respectively. 2. What is the safety of different types of disposable gloves for use in healthcare settings? The literature search did not identify any study on the safety of different types of disposable gloves for use in healthcare settings. 3. What is the cost-effectiveness of different types of disposable gloves for use in healthcare settings? The literature search did not identify any study on the cost-effectiveness of different types of disposable gloves for use in healthcare settings. 4. What are the evidence-based guidelines regarding the use of different types of disposable gloves for use in healthcare settings? Limitations The literature search did not identify any evidence-based guidelines regarding the use of different types of disposable gloves for use in healthcare settings The limited number of studies included in the review caution the interpretation of the findings. There were no studies on comparative clinical effectiveness, safety, and cost effectiveness between the two types of gloves of main interest, which are vinyl gloves and nitrile gloves. There are no evidence-based guidelines regarding the use of disposable gloves for use in healthcare settings. The findings from the included study lack generalizability since participants are limited to anesthesia providers. The impact on dexterity of other medical specialties is unknown, and it is unclear whether the same features may be preferred across specialties. Testing of each glove lasted approximately 30 minutes, so the impact of prolonged use is unknown. Disposable Gloves: Clinical and Cost-Effectiveness 5

6 CONCLUSIONS AND IMPLICATIONS FOR DECISION OR POLICY MAKING Findings from the included study showed there were no statistically significant differences in touch sensitivity or psychomotor performance among the tested types of gloves, despite a significant difference in subjective comfort rating. Facing a significant difference in manufacturer s suggested retail prices for different brand gloves and without evidence on the cost-effectiveness of different types of gloves for use in healthcare settings, the decision to purchase a specific type of glove at the present time should be a balance between glove comfort and glove costs. A study assessed the perforation rates of a latex glove (Biogel) and two latex-free polyisoprene gloves (Synthesis Polyco and Cardinal Esteem SMT) following 241 hip and knee arthroplasties, using a water distension test. 9 Latex-free gloves were found to have higher perforation rates compared to latex gloves, and the difference was statistically significant. A study in 2001 using water distension test also found that latex gloves had statistically significant smaller perforation rates than nitrile gloves. 10 Studies on safety/barrier quality of disposable gloves have expanded from prevention of pathogen transmission, to other hazards to healthcare workers, such as prevention of permeability of radioactive materials in nuclear medicine departments. Bench test studies on permeability of gloves used in a nuclear medicine department showed that latex glove (Biosafe PF Plus) showed worst resistance to permeability of [ 99m Tc]-pertechnetate and [ 18 F]-fluorodeoxyglucose than polyvinylchrloride gloves. 11 Bench test studies have shown that protection of rescuers from electrical shock during hands-on defibrillation can be a concern. 12,13 Current flow through examination gloves is not linear with respect to defibrillation voltage, and can abruptly jump up, which may cause the rescuer to interrupt chest compression. 12 The ability of nitrile examination gloves in providing uninterrupted chest compression during defibrillation was studied by measuring electrical resistance across the glove; it found that nitrile disposable gloves did not provide adequate electrical insulation for the rescuer to undertake defibrillation. 13 Together with the findings based on bench test studies from a previous Rapid Response report on the same topic in that stated Latex gloves may be more resistant to punctures than non-latex gloves in the surgical setting. Vinyl gloves are permeable to chemotherapy and are not suitable for use when exposure to cytotoxic agents is possible. No evidence was found that addressed the allergy potential, cost-effectiveness, effectiveness to prevent pathogen transmission, or recommended duration of use of latex versus non-latex gloves, this update report emphasizes the need for more evidence on the safety, clinical and cost-effectiveness of different disposable gloves in health care settings. PREPARED BY: Canadian Agency for Drugs and Technologies in Health Tel: Disposable Gloves: Clinical and Cost-Effectiveness 6

7 REFERENCES 1. Health Canada. List of recognized standards for medical devices [Internet]. Ottawa (ON): Health Canada. Subject: announcement of changes to the therapeutic products directorate's list of recognized standards for medical devices; 2012 Jul 27 [cited 2013 Sep 10]. Available from: 2. International Organization for Standardization. Single-use of medical examination gloves -- part 1: specification for gloves made from rubber latex or rubber solution [Internet]. Geneva (SW): The Organization; Report No.: ISO :2008. [cited 2013 Sep 10]. Available from: 3. Guidelines for latex and other gloves [Internet]. Regina (SK): Saskatchewan Labour, Occupation Health and Safety; [cited 2013 Sep 10]. Available from: 4. Palosuo T, Antoniadou I, Gottrup F, Phillips P. Latex medical gloves: time for a reappraisal. Int Arch Allergy Immunol. 2011;156(3): Standard Infection Control Precautions (SICPs) literature review: Personal Protective Equipment (PPE) - gloves [Internet]. Glasgow (UK): Health Protection Scotland; 2012 Jan. [cited 2013 Aug 20]. Available from: 6. Canadian Agency for Drugs and Technologies in Health. Disposable gloves for use in healthcare settings: a review of the clinical effectiveness, safety, cost-effectiveness, and guidelines [Internet]. Ottawa (ON): The Agency; 2011 May 27. (Rapid response report: summary with critical appraisal). [cited 2013 Aug 19]. Available from: /RC0271_Gloves_in_Healthcare_Settings_Final.pdf 7. Downs SH, Black N. The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions. J Epidemiol Community Health [Internet] Jun [cited 2013 Sep 6];52(6): Available from: 8. Johnson RL, Smith HM, Duncan CM, Torsher LC, Schroeder DR, Hebl JR. Factors that influence the selection of sterile glove brand: a randomized controlled trial evaluating the performance and cost of gloves. Can J Anaesth Jul;60(7): Thomas S, Aldlyami E, Gupta S, Reed MR, Muller SD, Partington PF. Unsuitability and high perforation rate of latex-free gloves in arthroplasty: a cause for concern. Arch Orthop Trauma Surg Apr;131(4): Murray CA, Burke FJ, McHugh S. An assessment of the incidence of punctures in latex and non-latex dental examination gloves in routine clinical practice. Br Dent J [Internet] Apr 14 [cited 2013 Sep 12];190(7): Available from: Disposable Gloves: Clinical and Cost-Effectiveness 7

8 11. Ridone S, Matheoud R, Valzano S, Di MR, Vigna L, Brambilla M. Permeability of gloves used in nuclear medicine departments to [Tc]-pertechnetate and [F]-fluorodeoxyglucose: Radiation protection considerations. Phys Med. 2013;29(5): Sullivan JL, Chapman FW. Will medical examination gloves protect rescuers from defibrillation voltages during hands-on defibrillation? Resuscitation Dec;83(12): Deakin CD, Lee-Shrewsbury V, Hogg K, Petley GW. Do clinical examination gloves provide adequate electrical insulation for safe hands-on defibrillation? I: Resistive properties of nitrile gloves. Resuscitation Jul;84(7): Disposable Gloves: Clinical and Cost-Effectiveness 8

9 Appendix 1: Selection of Included Studies 182 citations identified from electronic literature search and screened 178 citations excluded 4 potentially relevant articles retrieved for scrutiny (full text, if available) No potentially relevant report retrieved from other sources (grey literature, hand search) 4 potentially relevant reports 3 reports excluded (irrelevant design) 1 report included in review Disposable Gloves: Clinical and Cost-Effectiveness 9

10 Appendix 2: Characteristics of Included Study Table A1: Characteristics of Included studies First Author, Year, Country, Study objectives Intervention Comparator(s) Included patients and study types Main clinical outcomes reported Johnson, , Canada To determine whether glove use modifies tactile and psychomotor performance of health care providers when compared with no glove use and to evaluate factors that influence the selection of sterile glove brand (p 700) -Molnlycke-Biogel latex, powder-free -Ansell Sensi-Touch latex, powdered -Cardinal-Esteem with Neu-Thera nitrile, latexfree, powder-free -Ansell Perry Orthopaedic latex, powdered -Cardinal Esteem Tru-Blu stretchy nitrile, latex-free, powder-free -Comparator: no glove use Participants performed each test 6 times, once with bare hands and once with each of five different glove types. Randomized controlled study 42 anesthesia providers (9 anesthesiologists, 7 nurse anesthetists, 20 residents, 6 student nurse anesthetists) Psychomotor performance (tactile, fine motor/dexterity, hand-eye coordination) using CSPDT (fine motor dexterity and coordination), PPT (speed associated with hand-eye coordination) and SWM (touch sensitivity)* Glove comfort and performance using Likert scale (1 = marked negative impact, 2 = some negative impact, 3 = no impact, 4 = some positive impact, 5 = marked positive impact). *CSPDT: Crawford Small Parts Dexterity Test; PPT: Purdue Pegboard Test; SWM: Semmes-Weinstein Monofilament (touch sensitivity test) Disposable Gloves: Clinical and Cost-Effectiveness 10

11 Appendix 3: Summary of Critical Appraisal of Included Study Table A2: Summary of Critical Appraisal of Included Study First Author, Strengths Publication Year Johnson, Randomized controlled trial Hypothesis clearly described Method of selection from source population and representation described Main outcomes, interventions, participants characteristics, and main findings clearly described Estimates of random variability and actual probability values provided Participants blinded to all results during testing Losses to follow-up described (there was no loss) Study had sufficient power to detect a clinically important effect Limitations Generalizability limited to anesthesia providers Duration of glove use was not taken into account Physician investigator not blinded to the intervention studied Disposable Gloves: Clinical and Cost-Effectiveness 11

12 Appendix 4: Main Study Findings and Authors Conclusions Table A3: Main Study Findings and Authors Conclusions First Author, Publication Year Main Study Findings Authors Conclusions Research question 1 (clinical effectiveness of different typed of disposable gloves for use in healthcare settings) Johnson, SWM test [Mean (SD)] (touch sensitivity) - Radial nerve distribution Bare hands: 1.98 (0.37) Non-sterile Tru-Blu: 2.27 (0.37) Biogel: 2.32 (0.25) Sensi-Touch: 2.23 (0.25) Esteem: 2.27 (0.34) Perry Orthopaedic: 2.40 (0.32) Statistically significant difference for all gloves vs bare hands Statistically significant difference for Perry Orthopaedic vs non-sterile gloves - Median nerve distribution Bare hands: 2.16 (0.35) Non-sterile Tru-Blu: 2.32 (0.23) Biogel: 2.38 (0.19) Sensi-Touch: 2.36 (0.26) Esteem: 2.38 (0.18) Perry Orthopaedic: 2.42 (0.10) Statistically significant difference for all gloves vs bare hands Statistically significant difference for Perry Orthopaedic vs non-sterile gloves - Ulnar nerve distribution Bare hands: 2.25 (0.33) Non-sterile Tru-Blu: 2.44 (0.23) Biogel: 2.44 (0.18) Sensi-Touch: 2.37 (0.21) Esteem: 2.39 (0.25) Perry Orthopaedic: 2.52 (0.31) Statistically significant difference for all gloves vs bare hands No statistically significant difference between all sterile gloves vs non-sterile gloves CSPDT, sec [Mean (SD)] (fine motor dexterity and coordination) Bare hands: (38.2) Non-sterile Tru-Blu: (36.8) Biogel: (37.8) Sensi-Touch: (57.8) Esteem: (32.7) Perry Orthopaedic: (40.4) No statistically significant difference for all gloves vs bare hands,or between sterile gloves vs non-sterile gloves PPT, pegs/30sec [Mean (SD)] (speed associated with handeye coordination) Bare hands: 14.4 (2.1) Non-sterile Tru-Blu: 14.5 (1.8) Biogel: 13.9 (1.6) Sensi-Touch: 14.0 (2.0) Esteem: 14.2 (1.9) Given the observed similarities in touch sensitivity and psychomotor performance associated with five different glove types, our results suggest that subjective provider preferences, such as glove comfort, should be balanced against material costs. (p 700) Disposable Gloves: Clinical and Cost-Effectiveness 12

13 Table A3: Main Study Findings and Authors Conclusions First Author, Publication Year Main Study Findings Perry Orthopaedic: 13.1 (1.8) Statistically significant difference between Perry Orthopaedic gloves vs bare hands and vs non-sterile gloves Authors Conclusions Performance [Mean (SD)] (the higher the score, the better the comfort) Non-sterile Tru-Blu: 2.4 (0.8) Biogel: 2.5 (1.0) Sensi-Touch: 2.6 (0.8) Esteem: 2.8 (0.9) Perry Orthopaedic: 2.3 (0.9) No statistically significant difference between the performances of sterile vs non-sterile glove types. Comfort [Mean (SD)] Non-sterile Tru-Blu: 2.5 (0.8) Biogel: 3.0 (1.0) Sensi-Touch: 2.7 (0.8) Esteem: 3.1 (1.0) Perry Orthopaedic: 2.1 (0.9) Statistically significant difference among all glove types, with latex-free, powder-free Esteem and latex powder-free Biogel rated highest Annual cost estimates based on volume of sterile glove use ($US) Cost/pair Biogel $18.00 Esteem $5.75 Perry Ortho $3.00 Sensi-Touch $1.00 Cost for volume purchase based on MSRP (manufacturer s suggested retail price) 25,000/yr, 50,000/yr, 75,000/yr, 100,000/yr, 250,000/yr, 500,000/yr Biogel $450,000.00, $900,000.00, $1,350,000.00, $1,800,000.00, $4,500,000.00, $9,000, Esteem $143,750.00, $287,500.00, $431,250.00, $575,000.00, $1,437,500.00, $2,875, Perry Ortho $75,000.00, $150,000.00, $225,000.00, $300,000.00, $750,000.00, $1,500, Sensi-Touch $25,000.00, $50,000.00, $75,000.00, $100,000.00, $250,000.00, $500, Research question 2 (safety of different typed of disposable gloves for use in healthcare settings) There were no studies identified for this research question Research question 3 (cost- effectiveness of different typed of disposable gloves for use in healthcare settings) There were no studies identified for this research question Research question 4 (evidence-based guidelines regarding the use of different typed of disposable gloves for use in healthcare settings) Disposable Gloves: Clinical and Cost-Effectiveness 13

14 Table A3: Main Study Findings and Authors Conclusions First Author, Main Study Findings Publication Year There were no studies identified for this research question Authors Conclusions CSPDT: Crawford Small Parts Dexterity Test; PPT: Purdue Pegboard Test; SWM test: Semmes-Weinstein Monofilament test Disposable Gloves: Clinical and Cost-Effectiveness 14