Devices for home evaluation of women's health concerns

American Journal of Health-System Pharmacy

Volumn 65, Issue 4, 2008, Pages 299-314

  Scolaro, Kelly L ^a,b   Lloyd, Kimberly Braxton ^c,d   Helms, Kristen L ^d  

^a St Petersburg Campus ^*

^b UNIVERSITY OF FLORIDA HEALTH   (United States)

^c AUBURN UNIVERSITY   (United States)

^d AUBURN UNIVERSITY   (United States)

Author keywords

Breast neoplasms; Colonic neoplasms; Home tests; Menopause; Ovulation; Pregnancy; Urinary tract infections; Vaginal diseases; Women

Indexed keywords

CHORIONIC GONADOTROPIN; ESTRADIOL; ESTRONE GLUCURONIDE; FOLLITROPIN; GUAIAC; LUTEINIZING HORMONE; PROGESTERONE; TESTOSTERONE;

BASAL BODY TEMPERATURE; BREAST CANCER; BREAST SELF EXAMINATION; COLON CANCER; COST; DIAGNOSTIC ACCURACY; DIAGNOSTIC VALUE; EQUIPMENT; FEMALE; FERTILITY; HOME CARE; HUMAN; MENOPAUSE; MENSTRUAL CYCLE; MONEY; MYCOSIS; OVULATION; PREDICTION; PREGNANCY; PREGNANCY TEST; PRIORITY JOURNAL; REVIEW; SALIVA ANALYSIS; URINALYSIS; URINARY TRACT INFECTION; URINE DIPSTICK TEST; VAGINITIS; ANALYTICAL EQUIPMENT; APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; BREAST TUMOR; CHEMISTRY; COLON TUMOR; INSTRUMENTATION; METHODOLOGY; OVULATION DETECTION; SALIVA; SELF CARE; UTERINE CERVIX MUCUS; WOMEN'S HEALTH;

BREAST NEOPLASMS; BREAST SELF-EXAMINATION; CERVIX MUCUS; COLONIC NEOPLASMS; EQUIPMENT AND SUPPLIES; FEMALE; HUMANS; MENOPAUSE; OVULATION DETECTION; PREGNANCY; PREGNANCY TESTS; REAGENT KITS, DIAGNOSTIC; SALIVA; SELF CARE; URINARY TRACT INFECTIONS; VAGINITIS; WOMEN'S HEALTH;

EID: 39549091941     PISSN: 10792082     EISSN: None     Source Type: Journal    
DOI: 10.2146/ajhp060565     Document Type: Review

References (99)

1. Coile RC Jr. Futurescan 2003: a forecast of healthcare trends 2003-2007. Chicago: Health Administration Press; 2003.
2. Agency for Healthcare Research and Quality. Women's health care in the United States: selected findings from the 2004 national healthcare quality and disparities reports. Fact sheet. AHRQ publication no. 05-P021.2005 May. www.ahrq.gov/qual/nhqrwomen/nhqrwomen.htm (accessed 2007 Apr 24).
3. Freedonia Group. Patient monitoring systems to 2008. www.freedoniagroup. com/Patient-Monitoring-Systems.html (accessed 2006 Aug 10).
4. Shifren JL. Infertility. In: Carlson KJ, Eisenstat SA, Frigoletto FD et al., eds. Primary care of women. 2nd ed. St. Louis, MO: Mosby; 2002:352-7.
5. Lieu CL, Yoshida T. Infertility. In: DiPiro JT, Talbert RL, Yee GC et al., eds. Pharmacotherapy: a pathophysiologic approach. 5th ed. New York: McGraw-Hill Medical; 1999:1431-41.
6. Zetek Fertility and Conception. Ovacue Fertility Monitor product information. 2005. www.zetek.net/ovacue_fertility_monitor.htm (accessed 2007 May 10).
7. Jacobs MH, Blasco L, Sondheimer SJ. Ovulation prediction by monitoring salivary and vaginal electrical resistance with the peak ovulation predictor. Obstet Gynecol. 1989; 73:817-22.
8. Behre HM, Kuhlage J, Gabner C et al. Prediction of ovulation by urinary hormone measurements with the home use Clear-Plan Fertility Monitor: comparison with transvaginal ultrasound scans and serum hormone measurements. Hum Reprod. 2000; 15:2478-82.
9. Guida M, Tommaselli GA, Palomba S et al. Efficacy of methods for determining ovulation in a natural family planning program. Fertil Steril. 1999; 72:900-4.
10. Fehring RJ, Gaska N. Evaluation of the Lady Free Biotester in determining the fertile period. Contraception. 1998; 57:325-8.
11. Hall JE. Amenorrhea. In: Carlson KJ, Eisenstat SA, Frigoletto FD et al., eds. Primary care of women. 2nd ed. St. Louis, MO: Mosby; 2002:328-35.
12. Ruggiero RJ. Women's health: contraception. In: Koda-Kimble MA, Young LY, Kradjan WA et al., eds. Applied therapeutics: the clinical use of drugs. 7th ed. Baltimore: Lippincott Williams &. Wilkins; 2001:43-1-43-4.
13. Quattrocchi E, Hove I. Ovulation 8; pregnancy: home testing products. www.uspharmacist.com/oldformat.asp?url=newlook/files/feat/acf3003.htm (accessed 2007 May 8).
14. Wilcox AJ, Weinberg CR, Baird DD. Timing of sexual intercourse in relation to time of ovulation: effects on the probability of conception, survival of the baby, and sex of the baby. N Engl J Med. 1995; 333:1517-21.
15. Bryce RL, Shuter B, Sinosich MJ et al. The value of ultrasound, gonadotropin, and estradiol measurements for precise ovulation prediction. Fertil Steril. 1982; 37:42-5.
16. Kenigsberg D. New tests for the prediction of ovulation. Clin Obstet Gynecol. 1989; 32:533-40.
17. U.S. Department of Health and Human Services Office on Women's Health. Basal body temperature (BBT) chart. 2005 Jul 8. www.womenshealth.gov/pregnancy/ tools/bbt-chart-blank.pdf (accessed 2007 May 10).
18. Mayo Foundation for Medical Education and Research. How to get pregnant, basal body temperature (BBT). 2007 Jan 1. www.mayoclinic.com/health/how-to-get- pregnant/PR00103 (accessed 2007 May 10).
19. Charting your way to conception, www.fertilityfriend.com (accessed 2007 May 10).
20. Ovusoft, LLC. Taking charge of your fertility. www.ovusoft.com/products (accessed 2007 May 10).
21. Corsan GH, Ghazi D, Kemmann E. Home urinary luteinizing hormone immunoassays: clinical applications. Fertil Steril. 1990; 53:591-601.
22. Eichner SF, Timpe EM. Urinary based ovulation and pregnancy: point of care testing. Ann Pharmacother. 2004; 38:325-31.
23. Inverness Medical. Clearblue Easy, so advanced it is easy: digital ovulation test. 2006. www.clearblueeasy.com/ our_products_digital_ovulation_test_kit.cfm (accessed 2007 May 10).
24. Garcia JE, Jones GS, Wright GL. Prediction of the time of ovulation. Fertil Steril. 1981; 36:308-15.
25. World Health Organization Task Force Investigators. Temporal relationships between ovulation and defined changes in the concentration of plasma estradiol-17β, luteinizing hormone, follicle-stimulating hormone, and progesterone. Am J Obstet Gynecol. 1980; 138:383-90.
26. Miller PB, Soules MR. The usefulness of urinary LH kit for ovulation prediction during menstrual cycles of normal women. Obstet Gynecol. 1996; 87:13-7.
27. When the test really counts. Part two: the fertility window. Consum Rep. 2003; Feb:48-50.
28. Inverness Medical. Clearblue Easy Fertility Monitor: so clear it is easy. 2006. www.clearblueeasy.com/about_us.cfm (accessed 2007 May 10).
29. Your preconception and pregnancy resource center: ovulation testing - saliva tests. www.ovulation-calculator. com/ovulation-tests/saliva-ovulation- predictor.htm (accessed 2007 May 10).
30. Braat DD, Smeenk JM, Manger AP et al. Saliva test as ovulation predictor. Lancet. 1998; 352:1283-4.
31. Freundl G, Godehardt E, Kern PA et al. Estimated maximum failure rates of cycle monitors using daily conception probabilities in the menstrual cycle. Hum Reprod. 2003; 18:2628-33.
32. Roumen FJ, Dieben TO. Ovulation prediction by monitoring salivary electrical resistance with the Cue fertility monitor. Obstet Gynecol. 1988; 71:49-52.
33. Fernando RS, Betz G, Roumen FJ. Ovulation prediction by monitoring salivary electrical resistance with the Cue fertility monitor. Obstet Gynecol. 1988; 72:282-3.
34. Moreno JE, Khan-Dawood FS, Goldzieher JW. Natural family planning: suitability of the Cue method for defining the time of ovulation. Contraception. 1997; 55:233-7.
35. Office of NIH History. A timeline of pregnancy testing. http://history.nih.gov/exhibits/thinblueline/timeline.html (accessed 2006 Aug 10).
36. Home diagnostics/devices. In: Covington TR, ed. Nonprescription drug therapy: guiding patient self-care. 3rd ed. St. Louis, MO: Wolters Kluwer Health; 2004:1181-219.
37. Rosenthal WM, Briggs GC. Home testing and monitoring devices. In: Berardi RR, Kroon LA, McDermott JH et al., eds. Handbook of nonprescription drugs. 15th ed. Washington, DC: American Pharmacists Association; 2006:1048-76.
38. Center for Devices and Radiological Health. www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfPMN/PMN.cfm (accessed 2006 Jul 20).
39. Butler SA, Khanlian SA, Cole LA. Detection of early pregnancy forms of human chorionic gonadotropin by home pregnancy test devices. Clin Chem. 2001; 47:2131-6.
40. Cole LA, Khanlian SA, Sutton JM et al. Accuracy of home pregnancy tests at the time of missed menses. Am J Obstet Gynecol. 2004; 190:100-5.
41. When the test really counts. Part one: earliest pregnancy detection. Consum Rep. 2003; Feb:45-7.
42. Bastian LA, Nanda K, Hasselblad V et al. Diagnostic efficiency of home pregnancy test kits: a meta-analysis. Arch Fam Med. 1998; 7:465-9.
43. Davies S, Byrn F, Cole LA. Human chorionic gonadotropin testing for early pregnancy viability and complications. Clin Lab Med. 2003; 23:257-64.
44. Bringing medicine home: self-test kits monitor your health. Consum Rep. 1996; Ocf:47-55.
45. APhA annual over-the-counter product survey. Pharm Today. 2007; 13(4, suppl 1):1,4,10,14,20,23.
46. Wilcox AJ, Baird DD, Dunson D et al. Natural limits of pregnancy testing in relation to the expected menstrual period. JAMA. 2001; 286:1759-61.
47. Kahwati L, Haigler L, Rideout S. What is the best way to diagnose menopause? J Fam Pract. 2005; 54:1000-2.
48. Bastian L, Smith C, Nanda K. Is this woman perimenopausal? JAMA. 2003; 289:895-902.
49. Burger H, Dudley E, Hopper J et al. Prospectively measured levels of serum follicle-stimulating hormone, estradiol, and the dimeric inhibins during the menopausal transition in a population-based cohort of women. J Clin Endocrinol Metab. 1999; 84:4025-30.
50. Burger HG, Dudley EC, Hopper JL et al. The endocrinology of the menopausal transition: a cross-sectional study of a population-based sample. J Clin Endocrinol Metab. 1995; 80:3537-45.
51. Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002; 288:321-33.
52. Grady D, Herrington D, Bittner V et al. HERS Research Group. Cardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study follow-up (HERS II). JAMA. 2002; 288:49-57.
53. Hulley S, Furberg C, Barrett-Connor E et al. HERS Research Group. Noncardiovascular disease outcomes during 6.8 years of hormone therapy: Heart and Estrogen/progestin Replacement Study follow-up (HERS II). JAMA. 2002; 288:58-66.
54. Amerifit Nutrition. Estroven Monitor. www.estrovenmonitor.com/FAQ.html (accessed 2006 Jul 28).
55. Synova Healthcare. Menocheck. www.menocheck.com/pages/aboutmenocheck. htm#2 (accessed 2006 Jul 28).
56. Hormone Check. RU25 Plus. www.home-menopause-test.com/faq.html (accessed 2006 Jul 28).
57. ZRT Laboratory. Advanced home testing + assessment. www.zrtlab.com (accessed 2007 May 10).
58. Kaufman E, Lamster I. The diagnostic applications of saliva - a review. Crit Rev Oral Biol Med. 2002; 13:197-212.
59. Dabbs JM, Campbell BC, Gladue BA et al. Reliability of salivary testosterone measurements: a multicenter evaluation. Clin Chem. 1995; 41:1581-4.
60. Shirtcliff EA, Granger DA, Schwartz EB et al. Assessing estradiol in behavior studies using saliva and blood spots: simple radioimmunoassay protocols, reliability, and comparative validity. Horm Behav. 2000; 38:37-147.
61. Hagen J, Gott N, Miller D. Reliability of saliva hormone tests. J Am Pharm Assoc. 2003; 43:724-6.
62. Hormone education and saliva testing kits. http://salivatesting.com/ hormone_health_products/ (accessed 2007 May 10).
63. Home health testing. www.homehealthtesting.com/female-hormone-tests.htm (accessed 2007 May 10).
64. North Bay Diagnostics. www.northbaydiagnostics.com/Store/index.php (accessed 2007 May 10).
65. American Cancer Society. www.cancer.org (accessed 2006 Jun 18).
66. Bond J. Fecal occult blood test screening for colorectal cancer. Gastrointest Endosc Clin N Am. 2002; 12:11-21.
67. Hardcastle J, Chamberlain J. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet. 1996; 348:1471-7.
68. Kronborg O, Fenger C. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet. 1996; 348:1467-71.
69. Mandel J, Bond J, Church T et al. Reducing mortality from colorectal cancer by screening for fecal occult blood. N Engl J Med. 1993; 328:1365-71.
70. Scholefield J. Immunochemical testing for colorectal cancer. Lancet Oncol. 2006; 7:101-13.
71. Fraser C, Matthew C, Mowat N et al. Immunochemical testing of individuals positive for guaiac faecal occult blood test in a screening programme for colorectal cancer: an observational study. Lancet Oncol. 2006; 7:127-31.
72. Bioamerica. EZ Detect. http://ezdetect.com/html/about.html (accessed 2006 Jun 17).
73. First Check. First Check Hemocheck. www.firstcheckfamily.com/?gclid= CJfrirWpzoYCFQxDVAod9yY6-A (accessed 2006 Jun 17).
74. Beckman Coulter. Hemoccult. www.hemoccultfobt.com/healthcare/ health_gen_prod_instr.htm (accessed 2006 Jun 17).
75. Hemosure. Hemosure One Step. www.hemosure.com/product2.asp?CategoryID= Hemo100 (accessed 2006 Jun 17).
76. Greenwald B. A pilot study evaluating two alternate methods of stool collection for the fecal occult blood test. Medsurg Nurs. 2006; 15:89-94.
77. Stokamer C, Tenner C, Chaudhuri J et al. Randomized controlled trial of the impact of intensive patient education on compliance with fecal occult blood testing. J Gen Intern Med. 2005; 82:216-24.
78. American Cancer Society. Breast cancer. www.cancer.org (accessed 2006 Jun 22).
79. Humphrey L, Hefland M, Chan B. Breast cancer screening: a summary of the evidence for the US Preventative Services Task Force. Ann Intern Med. 2002; 137:347-60.
80. Tabar L, Vitak B, Chen H. Beyond randomized controlled trials: organized mammographic screening substantially reduces breast carcinoma mortality. Cancer. 2001; 91:1724-31.
81. Mammatech. Mammacare Personal Learning System. www.mammacare.com (accessed 2006 Jun 22).
82. Craig Medical Distribution. Aware Breast Self Examination and Resource Kit. www.craigmedical.com/products.htm (accessed 2006 Jun 20).
83. Lannin D, Ponn T. What should we teach women about breast self-examination today? J Womens Health. 2005; 14:529-30.
84. Franco AV. Recurrent urinary tract infections. Best Pract Res Clin Obstet Gynaecol. 2005; 19:861-73.
85. U.S. Department of Health and Human Services National Women's Health Information Center. Vaginal yeast infections. www.4woman.gov/faq/yeastinfect.htm (accessed 2006 Aug 10).
86. Multistix and URISTIX package insert. Tarrytown, NY: Bayer; 1992.
87. Pavletic AJ, Hawes SE, Geske JA et al. Experience with routine vaginal pH testing in a family practice setting. Infect Dis Obstet Gynecol. 2004; 12:63-8.
88. Riordan T, Macaulay ME, James JM et al. A prospective study of genital infections in a family-planning clinic. 1. Microbiological findings and their association with vaginal symptoms. Epidemiol Infect. 1990; 104:47-53.
89. Gynex. pHEM-Alert. www.gynex.com (accessed 2007 Apr 24).
90. Synova Healthcare. How Fem-V works. www.fem-v.com/how_works.php (accessed 2007 Apr 24).
91. Devillé WL, Yzermans JC, van Duijn NP et al. The urine dipstick test useful to rule out infections. A meta-analysis of the accuracy. BMC Urol. 2004; 4:1-14.
92. Gupta K, Hooton TM, Roberts PL et al. Patient-initiated treatment of uncomplicated recurrent urinary tract infections in young women. Ann Intern Med. 2001; 135:9-16.
93. Kessary H. Analysis of the VI-SENSE performance - manufacturer data. www.cs-commonsense.com (accessed 2006 Aug 10).
94. Roy S, Caillouette JC, Faden JS et al. Improving appropriate use of antifungal medications: the role of an over-the-counter vaginal pH self-test device. Infect Dis Obstet Gynecol. 2003; 11:209-16.
95. Ferris DG, Nyirjesy P, Sobel JD et al. Over-the-counter antifungal drug misuse associated with patient-diagnosed vulvovaginal candidiasis. Obstet Gynecol. 2002; 99:419-25.
96. Sultana RV, Zalstein S, Cameron P et al. Dipstick urinalysis and the accuracy of the clinical diagnosis of urinary tract infection. J Emerg Med. 2001; 20:13-9.
97. Associated Press. Home genetic tests for disease. 2005 Mar 6. www.cbsnews.com/stories/2005/03/06/health (accessed 2006 Aug 10).
98. Lewis C. Home diagnostic tests: the ultimate house call? FDA Consum Mag. 2001 Nov-Dec. www.fda.gov/fdac/features/2001/601_home.html (accessed 2006 Jun 15).
99. Davidow J. Self-service: at-home diagnostic kits empower patients to take more responsibility for their health. 2006 May 30. www.signonsandiego.com/ uniontrib/20060530/news_lz1c30self.html (accessed 2006 Jun 15).