LEADER 06674nam 2200661Ia 450 001 9910817015603321 005 20200520144314.0 010 $a0-309-17442-2 010 $a1-280-18682-8 010 $a9786610186822 010 $a0-309-59153-8 010 $a0-585-02408-1 035 $a(CKB)110986584752214 035 $a(OCoLC)42329048 035 $a(CaPaEBR)ebrary10055586 035 $a(SSID)ssj0000130027 035 $a(PQKBManifestationID)11148385 035 $a(PQKBTitleCode)TC0000130027 035 $a(PQKBWorkID)10081844 035 $a(PQKB)11302540 035 $a(Au-PeEL)EBL3376390 035 $a(CaPaEBR)ebr10055586 035 $a(OCoLC)923263435 035 $a(MiAaPQ)EBC3376390 035 $a(EXLCZ)99110986584752214 100 $a19980325d1998 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aContraceptive research, introduction, and use $elessons from Norplant /$fPolly F. Harrison and Allan Rosenfield, editors ; Subcommittee for Workshop on Implant Contraceptives: An illuminating case study in current dilemmas and possibilities, Committee on Contraceptive Research and Development, Division of Health Sciences Policy, Institute of Medicine 205 $a1st ed. 210 $aWashington, D.C. $cNational Academy Press$d1998 215 $a1 online resource (vii, 120 pages) $cillustrations 300 $aBased on a workshop held in April 1997. 311 $a0-309-05985-2 320 $aIncludes bibliographical references. 327 $aContraceptive Research, Introduction, and Use -- Copyright -- Acknowledgments -- Contents -- 1 Introduction -- 2 Workshop Report -- EFFICACY AND SAFETY -- Efficacy -- Safety -- Major Health-Related Events -- Significant Health-Related Problems -- Silicone Biocompatibility -- Progestin Effects on Vaginal HIV Transmission -- WHO USES NORPLANT AND HOW -- User Populations -- Method Continuation and Discontinuation -- Side Effects as Factors -- User Satisfaction -- Barriers to Discontinuation -- Cost and Cost-Effectiveness -- Effects of Media Coverage and Litigation on Norplant Use -- INSERTION AND REMOVAL: EXPERIENCE AND IMPLICATIONS -- Technical Aspects -- Case Experiences -- Rates of Complicated Removals -- Implications -- CONSUMER PERSPECTIVES -- Communication and Quality of Care -- Quality of Care -- Informed Decision-Making -- Importance -- Content -- Special Challenges -- Potential for Abuse -- Consumer Involvement -- NEW APPROACHES -- Reproductive Health Technologies Project's "Boom and Bust Initiative -- The WHO Strategic Approach to Contraceptive Introduction -- A ''Government Standards Defense -- 3 Workshop Summary and Analysis -- DATA REVIEW -- Efficacy -- Safety -- User Profiles -- Side Effects -- Continuation and Discontinuation -- User Satisfaction -- Postmarketing Surveillance -- Cost-Effectiveness -- LESSONS LEARNED -- NEXT STEPS: AREAS FOR CONSIDERATION AND ACTION -- Areas for Strengthening or Expansion -- 1. Clinical Research -- 2. Market Research -- 3. "Pre-introduction -- 4. Informed Decision-Making -- 5. Postmarketing Surveillance -- Areas for New Initiative -- 6. Credentialing -- 7. Core Guidelines for Long-Acting Contraceptives -- 8. Costs -- 9. Product Liability -- FINAL COMMENT -- ENDNOTES -- Appendixes -- A Presentation Summaries -- Presentation 1 -- Background -- Methodology -- Findings -- Age and Educational Levels. 327 $aMajor Health-Related Events -- Significant Health-Related Problems -- Continuation and Removals -- Efficacy -- Conclusions -- Presentation 2 -- Background -- Methodology -- Findings -- Pregnancy and Continuation Rates -- Reasons for Discontinuation -- Removal Difficulties -- Mortality and Hospitalization -- Conclusions -- Presentation 3 -- Background -- Methodology -- Findings -- Conclusions -- Presentation 4 -- Background -- Findings -- Composition -- Inflammatory Wound Healing Reaction and Blood Protein Absorption -- Conclusions -- Presentation 5 -- Background -- Methodology -- Findings -- Conclusions -- Presentation 6 -- Background and Methodology -- Findings -- Conclusions -- Presentation 7 -- Background -- Findings -- Conclusions -- Presentation 8 -- Background -- Methodology -- Findings and Conclusions -- Sample Characteristics -- Continuation and Discontinuation -- Media Effects -- Norplant and Coercion -- Presentation 9 -- Background -- Methodology -- Findings -- Sample Characteristics -- Continuation and Discontinuation -- The Question of Coercion -- Postdiscontinuation Experience -- Conclusions -- Presentation 10 -- Background -- Methodology -- Findings -- Conclusions -- Presentation 11 -- Background -- Removal Techniques -- Standard Technique -- Pop-Out Technique -- U Technique -- Removal Difficulties and Training -- Conclusions -- Presentation 12 -- Background -- Methodology -- Findings -- Conclusions -- Presentation 13 -- Background -- Methodology -- Findings -- Conclusions -- Presentation 14 -- Background -- Findings -- Choice -- Removal on Demand -- Tracking Capacity -- Conclusions -- Presentation 15 -- Background -- Discussion -- The Role of the FDA -- The Potential Role of a Federal Standards Defense -- ENDNOTES -- B Norplant: Historical Background -- THE TECHNOLOGY -- HISTORY -- ENDNOTES -- C Workshop Agenda. 327 $aImplant Contraceptives: An Illuminating Case Study in Current Dilemmas and Possibilities 7-8 April 1997 -- NATIONAL ACADEMY OF SCIENCES INSTITUTE OF MEDICINE -- WORKSHOP -- PARTICIPANTS. 330 $aContains an examination of Norplant's efficacy and safety, its user populations, training for insertion and removal, consumer perspectives - quality of care, informed decisionmaking, and consumer involvement - and approaches to contraceptive development and introduction. This book's appendix contains summaries of 17 workshop presentations. 606 $aContraception$xResearch$vCongresses 606 $aBirth control$xResearch$vCongresses 615 0$aContraception$xResearch 615 0$aBirth control$xResearch 676 $a613.9/4 701 $aHarrison$b Polly F$01646797 701 $aRosenfield$b Allan$01646798 712 02$aInstitute of Medicine (U.S).$bCommittee on Contraceptive Research and Development. 712 02$aInstitute of Medicine (U.S.).$bSubcommittee for Workshop on Implant Contraceptives : an Illuminating Case Study in Current Dilemmas and Possibilities. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910817015603321 996 $aContraceptive research, introduction, and use$93993987 997 $aUNINA