A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system.

Fear of the speculum and feelings of vulnerability during the gynecologic exams are two of the biggest barriers to cervical cancer screening for women. To address these barriers, we have developed a novel, low-cost tool called the Callascope to reimagine the gynecological exam, enabling clinician and self-imaging of the cervix without the need for a speculum. The Callascope contains a 2 megapixel camera and contrast agent spray mechanism housed within a form factor designed to eliminate the need for a speculum during contrast agent administration and image capture. Preliminary bench testing for comparison of the Callascope camera to a $20,000 high-end colposcope demonstrated that the Callascope camera meets visual requirements for cervical imaging. Bench testing of the spray mechanism demonstrates that the contrast agent delivery enables satisfactory administration and cervix coverage. Clinical studies performed at Duke University Medical Center, Durham, USA and in Greater Accra Regional Hospital, Accra, Ghana assessed (1) the Callascope's ability to visualize the cervix compared to the standard-of-care speculum exam, (2) the feasibility and willingness of women to use the Callascope for self-exams, and (3) the feasibility and willingness of clinicians and their patients to use the Callascope for clinician-based examinations. Cervix visualization was comparable between the Callascope and speculum (83% or 44/53 women vs. 100%) when performed by a clinician. Visualization was achieved in 95% (21/22) of women who used the Callascope for self-imaging. Post-exam surveys indicated that participants preferred the Callascope to a speculum-based exam. Our results indicate the Callascope is a viable option for clinician-based and self-exam speculum-free cervical imaging.Clinical study registration ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/record/ NCT00900575, Pan African Clinical Trial Registry (PACTR) https://www.pactr.org/ PACTR201905806116817.

Piloting the Use of Smartphones, Reminders, and Accountability Partners to Promote Skin Self-Examinations in Patients with Total Body Photography: A Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to evaluate the use of a mobile application (app) in patients already using total body photography (TBP) to increase skin self-examination (SSE) rates and pilot the effectiveness of examination reminders and accountability partners. DESIGN: Randomized controlled trial with computer generated randomization table to allocate interventions. SETTING: University of Pennsylvania pigmented lesion clinic. PARTICIPANTS: 69 patients aged 18 years or older with an iPhone/iPad, who were already in possession of TBP photographs. INTERVENTION: A mobile app loaded with digital TBP photos for all participants, and either (1) the mobile app only, (2) skin examination reminders, (3) an accountability partner, or (4) reminders and an accountability partner. MAIN OUTCOME MEASURE: Change in SSE rates as assessed by enrollment and end-of-study surveys 6 months later. RESULTS: Eighty one patients completed informed consent, however 12 patients did not complete trial enrollment procedures due to device incompatibility, leaving 69 patients who were randomized and analyzed [mean age 54.3 years, standard deviation 13.9). SSE rates increased significantly from 58% at baseline to 83% at 6 months (odds ratio 2.64, 95% confidence interval 1.20-4.09), with no difference among the intervention groups. The group with examination reminders alone had the highest (94%) overall satisfaction, and the group with accountability partners alone accounted for the lowest (71%). CONCLUSION: A mobile app alone, or with reminders and/or accountability partners, was found to be an effective tool that can help to increase SSE rates. Skin examination reminders may help provide a better overall experience for a subset of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02520622.

Direct comparison of two vaginal self-sampling devices for the detection of human papillomavirus infections.

BACKGROUND AND OBJECTIVES: Two devices for vaginal self-sampling of dry cell material (Evalyn Brush, Rovers Medical Devices; Qvintip, Aprovix) were compared using the Abbott RealTime High Risk HPV test. STUDY DESIGN: Both self-sampling devices (change of order with every patient) including instructions for use and a questionnaire were handed to 146 patients in a colposcopy clinic prior to scheduled colposcopies with collection of cervical reference specimens by gynaecologists using a broom-like device. Matched self-collected and physician collected specimens were transferred to ThinPrep medium and tested for the presence of hr-HPV. Biopsies were taken if indicated by colposcopy. RESULTS: Evaluation of 136 patients with complete data (136/146; 93.2%) showed high agreement of overall hr-HPV detection rates between self-collected and clinician-collected specimens (Evalyn: 91.2% [kappa 0.822]; Qvintip: 89.0% [kappa 0.779]). Colposcopy and histological evaluation revealed 55 women without cervical intraepithelial neoplasia (CIN), 32 CIN1, 34 CIN2, 14 CIN3 and one adenocarcinoma in situ. Hr-HPV testing detected all CIN3+ cases on the clinician-taken or Evalyn self-samples (14/14) and 93% of them on the Qvintip samples (13/14). There was no significant difference regarding the sensitivity for CIN2+ or CIN3+ and specificity of hr-HPV testing on self- vs. clinician samples and on Evalyn vs. Qvintip. Based on signal intensities of ß-globin, the observed DNA concentration with Evalyn samples (mean CN: 22.0; 95%-CI: 21.5-22.6) was found to be significantly higher compared to that of Qvintip samples (mean CN: 23.8; 95%-CI 23.2-24.4), regardless of the order of self-sampling (p<0.0001). Most women considered self-sampling easy and comfortable. Qvintip was considered easier than the Evalyn Brush to understand (p<0.001) and to use (p=0.002). DISCUSSION: This study confirms that hr-HPV testing with a clinically validated PCR-based HPV assay is as accurate on self-samples as on clinician-samples without significant difference between both self-sampling devices.

CLOCK CHART(®): a novel multi-stimulus self-check visual field screener.

PURPOSE: CLOCK CHART(®) is a multi-stimulus-type self-check visual field screening sheet developed by our group. The test chart is rotated during the examination, and the visual field abnormalities are pointed out by the patients themselves. In this study, we evaluated the clinical usefulness of this chart in patients with glaucoma. METHODS: We studied 114 eyes of 114 glaucoma patients (average age 60.0 ± 11.1 years) and 45 eyes of 45 normal individuals (average age 45.0 ± 16.4 years) using CLOCK CHART(®). The static visual fields were obtained using the Octopus 101 G2 program and classified using the Aulhorn classification as modified by Greve (stages 0-I to IV) and by mean defect (MD; early <6 dB; moderate 6 ≤ MD ≤12 dB; severe >12 dB).The sensitivity and specificity of CLOCK CHART(®) for detecting visual field abnormalities were evaluated within the entire 25° field and at the 5°, 10°, 15°, 20°, and 25° eccentricity zones. The visual field agreement between the results of CLOCK CHART(®) and the static visual fields were also evaluated. RESULTS: In glaucomatous eyes, the sensitivity of CLOCK CHART(®) was 85, 93, and 100 % for Greve stages I, II and III-VI, respectively, and 87, 93, and 97 % for the MD value in early, moderate, and severe eyes, respectively. The agreement of the visual field defect area in CLOCK CHART(®) with the static fields was 85 and 100 % with Greve stages 0-I to I and II-VI, respectively, and 91, 96, and 96 % in early, moderate and severe glaucomatous eyes according to MD, respectively. The specificity of CLOCK CHART(®) was 89 %. CONCLUSION: CLOCK CHART(®) is a simple and reliable self-check screening chart for detecting visual field abnormalities in patients with glaucoma.

Smartphone applications for melanoma detection by community, patient and generalist clinician users: a review.

Smartphone health applications ('apps') are widely available but experts remain cautious about their utility and safety. We reviewed currently available apps for the detection of melanoma (July 2014), aimed at general community, patient and generalist clinician users. A proforma was used to extract and assess each app that met the inclusion criteria, and we undertook content analysis to evaluate their content and the evidence applied in their development. Thirty-nine apps were identified with the majority available only for Apple users. Over half (n = 22) provided information or education about melanoma, ultraviolet radiation exposure prevention advice, and skin self-examination strategies, mainly using the ABCDE (A, Asymmetry; B, Border; C, Colour; D, Diameter; E, Evolving) method. Half (n = 19) helped users take and store images of their skin lesions either for review by a dermatologist or for self-monitoring to identify change, an important predictor of melanoma; a similar number (n = 18) used reminders to help users monitor their skin lesions. A few (n = 9) offered expert review of images. Four apps provided a risk assessment to patients about the probability that a lesion was malignant or benign, and one app calculated users' future risk of melanoma. None of the apps appeared to have been validated for diagnostic accuracy or utility using established research methods. Smartphone apps for detecting melanoma by nonspecialist users have a range of functions including information, education, classification, risk assessment and monitoring change. Despite their potential usefulness, and while clinicians may choose to use apps that provide information to educate their patients, apps for melanoma detection require further validation of their utility and safety.

An automated hand-held elastometer for quantifying the passive stiffness of the levator ani muscle in women.

AIM: Design and develop an automated, hand-held instrument (elastometer) to assess in vivo passive stiffness of the pelvic floor muscle. MATERIALS AND METHODS: The elastometer system consisted of a hand piece, real-time controller, and laptop computer. A cable connected the hand-piece to the controller, which communicated with a laptop computer via an ethernet connection. Force sensitivity calibration and displacement accuracy were determined experimentally using a spring load and an Instron mechanical tester. A test re-test series quantified the in vivo repeatability (within a procedure) and reproducibility (between procedures after a 5 min delay) of passive stiffness in volunteers (n = 20). Stiffness was determined from the gradient of the force-displacement curve for each cycle. RESULTS: The force-aperture spring measurements from the elastometer showed consistent (r(2) = 1.0000) agreement with those measured by the Instron. The difference between spring stiffness as measured by the elastometer and the Instron (388.1 N/m cf. 388.5 N/m, respectively) was negligible. The intra-class correlation coefficient for repeatability within procedures was 0.986 95% CI (0.964-0.994) n = 20, and reproducibility between procedures ICC 0.934 (95% CI 0.779-0.981) n = 12. Bland-Altman analysis determined a bias of 0.3 and 18.5 N/m, for repeatability and reproducibility respectively. Neither bias is likely to be clinically significance. CONCLUSION: The elastometer demonstrated very good repeatability and accuracy in the measurement of force/displacement during in vitro testing. There was a high degree of repeatability and reproducibility in stiffness measurements in a test re-test series. Our results demonstrate the elastometer is accurate and reliable and thereby suitable for larger clinical trials.

Exploring risks and benefits of point-of-care tests for healthcare and self-tests for laypersons: an interview study assessing complementary expert perspectives on diagnostic lab-on-a-chip systems.

BACKGROUND: A commercial breakthrough of point-of-care testing (POCT) and self-tests for laypersons (direct-to-consumer applications, DTC) is anticipated based on the advancements in the development of lab-on-a-chip system (LOC) technology. OBJECTIVE: The aim of this study was to investigate risks and benefits of LOC based diagnostic devices for healthcare and private self-testers. METHODS: Interviews with 22 developers/researchers of LOC technology and 10 technology assessment experts were conducted about the (a) need for, (b) benefits, and (c) risks of LOCs for healthcare and as DTC applications. A qualitative content analysis was conducted. RESULTS: Need for LOCs were seen mainly for healthcare, but not as DTC applications for fatal diseases. While benefits were seen mainly for healthcare and partially for DTC applications (e.g. faster diagnostics, more favourable diagnostics, POCT), risks were emphasised especially for DTC applications and less frequently for healthcare (e.g. various technical challenges, misinterpretation of test results, quality/reliability requirements). CONCLUSIONS: Medical expertise is the key imperative for the application of LOC based portable diagnostic devices in healthcare and particularly for self-testing. LOCs have to be designed to be easily operated and interpreted by self-testers. For healthcare, LOCs are envisaged to be a promising emerging technology with various benefits.

Disposable platform provides visual and color-based point-of-care anemia self-testing.

BACKGROUND: Anemia, or low blood hemoglobin (Hgb) levels, afflicts 2 billion people worldwide. Currently, Hgb levels are typically measured from blood samples using hematology analyzers, which are housed in hospitals, clinics, or commercial laboratories and require skilled technicians to operate. A reliable, inexpensive point-of-care (POC) Hgb test would enable cost-effective anemia screening and chronically anemic patients to self-monitor their disease. We present a rapid, stand-alone, and disposable POC anemia test that, via a single drop of blood, outputs color-based visual results that correlate with Hgb levels. METHODS: We tested blood from 238 pediatric and adult patients with anemia of varying degrees and etiologies and compared hematology analyzer Hgb levels with POC Hgb levels, which were estimated via visual interpretation using a color scale and an optional smartphone app for automated analysis. RESULTS: POC Hgb levels correlated with hematology analyzer Hgb levels (r = 0.864 and r = 0.856 for visual interpretation and smartphone app, respectively), and both POC test methods yielded comparable sensitivity and specificity for detecting any anemia (n = 178) (<11 g/dl) (sensitivity: 90.2% and 91.1%, specificity: 83.7% and 79.2%, respectively) and severe anemia (n = 10) (<7 g/dl) (sensitivity: 90.0% and 100%, specificity: 94.6% and 93.9%, respectively). CONCLUSIONS: These results demonstrate the feasibility of this POC color-based diagnostic test for self-screening/self-monitoring of anemia. TRIAL REGISTRATION: Not applicable. FUNDING: This work was funded by the FDA-funded Atlantic Pediatric Device Consortium, the Georgia Research Alliance, Children's Healthcare of Atlanta, the Georgia Center of Innovation for Manufacturing, and the InVenture Prize and Ideas to Serve competitions at the Georgia Institute of Technology.

Bioelectrical impedance self-measurement protocol development and daily variation between healthy volunteers and breast cancer survivors with lymphedema.

BACKGROUND: A significant percentage of breast cancer survivors are at risk for lymphedema for which lifelong self-care is required. Previous studies suggest that less than 50% of breast cancer survivors with lymphedema (BCS-LE) perform prescribed self-care tasks and that even wearing a compression sleeve, the most commonly reported self-care activity, is done irregularly. Reasons for poor self-care adherence include perceived lack of results from self-care (no available arm volume data) and perceived inability to manage the condition. METHODS AND RESULTS: A two-part pilot study was conducted to: 1) develop and determine the feasibility of a self-measurement protocol using a single frequency bioelectrical impedance device; and 2) examine daily variation in extracellular volume in healthy and lymphedematous limbs. Healthy and BCS-LE volunteers were recruited to refine and test a self-measurement protocol. Volunteers were trained in the use of the device and measured for 5 consecutive days in a laboratory setting. They were then given the device to use at home for an additional 5 consecutive days of self-measurement. All volunteers completed each scheduled home measurement. Daily variability in both groups was noted. CONCLUSIONS: Home self-measurement using bioelectrical impedance is feasible, acceptable, and captures change. This has implications for both self-care support and for the possibility of incorporating self-measurement using bioelectrical impedance in future clinical trials examining effectiveness of lymphedema treatment.

Mujer con patología mamaria. ¿qué factores se asocian a la práctica de la autoexploración? / Profile of women with breast disease wich does self-exploration. Which are the factors associated with this practice?

Antecedentes. En las últimas décadas la lucha contra el cáncer de mama se ha centrado, básicamente, en el tratamiento y en la prevención secundaria (fundamentalmente la detección precoz). La autoexploración mamaria, aunque no se ha demostrado que reduzca la mortalidad, sí es importante respecto a los casos detectados por la propia mujer (se estima que un 90% del total) y principalmente en los cánceres de intervalo. Objetivos. Identificar entre mujeres con cáncer de mama, cuántas realizan la autoexploración y los factores asociados. Describir las características clínico-patológicas de los cánceres en las mujeres que sí realizan la autoexploración. Metodología. En mujeres diagnosticadas de cáncer de mama, en un hospital de la provincia de Cádiz, España, se reconstruye de manera retrospectiva la historia relacionada con el proceso del cáncer, es decir, sintomatología, factores psicosociales que determinan el contacto con el sistema sanitario, realización de prácticas preventivas (participación en el Programa de Detección Precoz del Cáncer de Mama –PDPCM–, autoexploración mamaria,...). Se realiza una descripción clínico-patológica del tumor: síntoma de presentación, tamaño tumoral, ganglios negativos, grado de diferenciación histológica. Resultados. Se estudiaron 149 mujeres con cáncer de mama, de las cuales el 52% realizaba autoexploración. Las mujeres que realizan autoexploración son más jóvenes (54,78 años frente a 65,63), están casadas (66,2%), se encuentran laboralmente activas y tienen un nivel de estudios mayor. La valoración de la aparición del primer síntoma como algo importante se correlaciona positivamente con aquellas mujeres que practican la autoexploración. En cuanto a otras prácticas preventivas, las que se autoexploran son también las que más acuden al programa de detección precoz (74,4% frente a 29,5% en las que no se autoexploran). En cuanto a las características clínico-patológicas del tumor en las mujeres que se autoexploran: el tamaño tumoral medio es de 2,5 cm; el 50,7% se halla bien diferenciado, y en un 59,1% de los casos los ganglios son negativos. Conclusiones. Las mujeres que se autoexploran son más jóvenes, tienen un nivel educativo mayor, están casadas, se encuentran laboralmente activas y suelen participar en otras prácticas preventivas. En ellas, los tumores diagnosticados presentan un menor tamaño, se diagnostican en estadios más precoces y por lo general presentan mejor grado de diferenciación(AU)

Background/Aims: In recent decades the fight against breast cancer has focused primarily on the treatment and secondary prevention (early detection mainly). In the case of breast self-examination, althought it has not been prove to reduce mortality, it is important in cases detected by women themselves (it is estimated 90% of total), mainly in the interval cancers. Objectives: To identify within women with breast cancer, how many do self-examination and identify associated factors. Describe the clinical and pathological features of cancers in women who do perform self-examination. Methodology: In women diagnosed with breast cancer during 2007 in a hospital in the province of Cadiz, Spain, is reconstructed in retrospect the story related the cancer process: symptoms, psychosocial factors that determine the contact with the health system, preventive practices (self-examination, mammography screening). A description of the pathological tumor: presenting symptom, tumor size, node negative, grade of differentiation… Results: We studied 149 women with breast cancer, from whom 52% did self-exploration. Women who performed self-examination were younger (54.78 years) against the women who did not (65.63 years), married (66.2%), active workers and have a higher educational level. The assessment of the first symptoms in these women as «important» is positively correlated with those women who practice self-examination. For other preventive practices, women who does self-examination are also the most actives in early detection programs (74.4% against 29.5% which didn’t do self-examination). For the pathologic characteristics of tumor in women who did self-examination: the tumor size was 2.5 cm, 50.7 / are well differentiated, and 59.1% of cases the nodes are negative. Conclusions: Women who does self-examination are younger, have higher educational level, are married, are active workers and are often involved in other preventive practices. On them, the tumors diagnosed have a smaller size, are diagnosed at earlier stages and usually present better degree of differentiation(AU)

[The magnifying mirror to enable patients with diabetes to self-examine their feet]. / Le miroir grossissant pour l'autosurveillance podologique du patient diabétique.

The treatment of foot wounds is a real public health issue for patients with diabetes. A specific educational tool has been developed for foot self-examination: the magnifying mirror. Its use, during nurse consultations and in the patient's home, actively contributes to foot wound prevention messages and actions.

Self-test device for cytology and HPV testing in rural Appalachian women: an evaluation.

OBJECTIVE: To determine the efficacy of a self-test device for obtaining vaginal/cervical samples for HPV DNA and cytologic testing. STUDY DESIGN: We recruited 878 Appalachian women; 775 were able to submit a self-test sample and a provider-collected sample. Each specimen was assessed for cytologic abnormalities and for high-risk HPV infection. RESULTS: Specimen adequacy: 869 of 878 (99%) women had sufficient material for cytologic analysis in provider-collected samples compared to 771 of 775 (99%) self-collected specimens (p = NS). There was sufficient cellular material (DNA) for HPV testing in 724 of 834 (87%) provider-collected samples compared to 690 of 736 (94%) self-collected specimens (p <0.04). In the provider-collected samples, 654 of 869 (75%) women had endocervical cells compared to 103 of 771 (13%) self-collected specimens (p <0.001). HPV assessment: 142 (19%) had high-risk HPV DNA detected. Of those women, 28 (20%) had HPV infection detected on the provider-collected specimen only, 51 (36%) on the self-collected specimen only, and 63 (44%) had HPV DNA on both specimens. CONCLUSION: Our device is sufficient to obtain an adequate number of epithelial cells for cytologic and HPV testing.

[Comparison of Preferential Hyperacuity Perimeter (PHP) test and Amsler grid test in the diagnosis of different stages of age-related macular degeneration]. / Vergleich des Preferential-Hyperacuity-Perimeter (PHP)-Tests mit dem Amsler-Netz-Test bei der Diagnose verschiedener Stadien der altersbezogenen Makuladegeneration.

BACKGROUND: Age-related macular degeneration (ARMD) is the leading cause of blindness in people over 65 years of age. A rapid loss of vision occurs especially in cases with choroidal neovascularisation. Early detection of ARMD and timely treatment are mandatory. We have prospectively studied the results of two diagnostic self tests for the early detection of metamorphopsia and scotoma, the PHP test and the Amsler grid test, in different stages of ARMD. PATIENTS AND METHODS: Patients with ARMD and best corrected visual acuity of 6/30 or better (Snellen charts) were examined with a standardised protocol, including supervised Amsler grid examination and PHP, a new device for metamorphopsia or scotoma measurement, based on the hyperacuity phenomenon in the central 14 degrees of the visual field. The stages of ARMD were independently graded in a masked fashion by stereoscopic ophthalmoscopy, stereoscopic fundus colour photographs, fluorescein angiography, and OCT. The patients were subdivided into 3 non-neovascular groups [early, late (RPE atrophy > 175 microm) and geographic atrophy], a neovascular group (classic and occult CNV) and an age-matched control group (healthy volunteers). RESULTS: 140 patients, with ages ranging from 50 to 90 years (median 68 years), were included in the study. Best corrected visual acuity ranged from 6/30 to 6/6 with a median of 6/12. 95 patients were diagnosed as non-neovascular ARMD. Thirty eyes had early ARMD (9 were tested positive by the PHP test and 9 by the Amsler grid test), and 50 late ARMD (positive: PHP test 23, Amsler grid test 26). The group with geographic atrophy consisted of 15 eyes (positive: PHP test 13, Amsler grid test 10). Forty-five patients presented with neovascular ARMD (positive: PHP test 38, Amsler grid test 36), 34 volunteers served as control group (positive: PHP test 1, Amsler grid test 5). CONCLUSIONS: The PHP and Amsler grid tests revealed comparable results detecting metamorphopsia and scotoma in early ARMD (30 vs. 30 %) and late ARMD (46 vs. 52 %). However, the PHP test more often revealed disease-related functional changes in the groups of geographic atrophy (87 vs. 67 %) and neovascular ARMD (84 vs. 80 %). This implies that the PHP and Amsler grid self tests are useful tools for detection of ARMD and that the PHP test has a greater sensitivity in the groups of geographic atrophy and neovascular AMD.

Clinical evaluation of the intraocular pressure in patients with glaucoma or ocular hypertension by a self-assessable tonometer.

PURPOSE: To investigate the clinical efficacy of a new patient-operated intraocular pressure tool, the Proview eye pressure monitor (PEPM; Bausch & Lomb, Inc., Rochester, NY), for monitoring intraocular pressure (IOP) in patients with glaucoma or ocular hypertension. PATIENTS AND METHODS: One hundred and forty eyes of 70 Taiwanese patients from the Tri-Service General Hospital (Taiwan, Republic of China) who had been diagnosed with ocular hypertension or glaucoma were studied. After being fully trained during an initial clinic visit, patients measured their own IOP with the PEPM at home. The IOPs were measured again using a Haag-StreitBern Goldmann tonometer (GT; Haag-Streit, Köniz, Switzerland) during subsequent outpatient visits. The training time, assessment of the patients' ease of PEPM use, and accuracy of measured PEPM IOPs in relation to GT IOPs were recorded and analyzed. RESULTS: Relative to GT readings, PEPM readings tended to be overestimated at lower pressure (<10 mmHg) and underestimated at higher pressure (>20 mmHg). Between 10 to 20 mmHg, PEPM measurements did not significantly differ from GT measurements. Up to 80% of the PEPM measurements fell within +/- 3 mmHg of the corresponding GT readings. When consideration was limited to GT readings of > or =21 mmHg, PEPM measured IOPs of > or =21 mmHg with a sensitivity of 80% and a specificity of 90%. The mean satisfaction rating of PEPM use was 88.3 +/- 2.0 (maximum, 100). The mean training time for appropriate use of PEPM was 17.9 +/- 4.0 minutes. The older the patients, the longer the training time that was required. CONCLUSION: Our data suggest that after appropriate training: (1) PEPM and GT measurements correspond well between 10 mmHg and 20 mmHg and (2) PEPM could offer patients with glaucoma or ocular hypertension an easy-to-use, substantially reliable means of selfmonitoring IOP.

Experience with a self-administered device for cervical cancer screening by Thai women with different educational backgrounds.

BACKGROUND: This descriptive study was carried out to test the acceptability of a self-administered device for cervical cancer screening and assess certain risk factors in relation to the cancer in two districts of Khon Kaen province in Northeast Thailand. METHODS: A total of 354 women from the villages were selected (including 143 teachers from secondary and primary schools; 24 health officers from the rural health centres, and 37 nurses from the University Hospital, Khon Kaen University). The Kato device was introduced and used by the women, who were then asked to give their opinion on its usage. RESULTS: The Kato device was generally well accepted by the women. However, many of those with a higher educational background were more sceptical towards the device than their counterparts from the villages. CONCLUSIONS: A suitable approach to strengthen the control of cervical cancer in the rural areas of Thailand might be to introduce the Kato device as an integral part of primary health care. The introduction of the device should go along with health education on the importance of avoiding infection with the papilloma viruses. This message should be transmitted to both females and males.

Improving appropriate use of antifungal medications: the role of an over-the-counter vaginal pH self-test device.

OBJECTIVES: To determine whether patients can understand and use the vaginal pH device in the diagnosis of vaginitis. To compare whether vaginal pH readings determined by patients and healthcare providers are similar. To determine whether vaginal pH can reduce inappropriate over-the-counter (OTC) antifungal medication use and improve the correct diagnosis of vaginitis. METHODS: One hundred and fifty-one women indicated their belief about the cause of their vaginal infection, read the instructions of the vaginal pH device package insert, used the device and interpreted the findings. The patient interpretations were compared with results obtained by healthcare providers, blinded to patient findings. RESULTS: Over 96% of patients stated that they could easily read the instructions, use the vaginal pH device and interpret the readings. They obtained the same readings as healthcare professionals (Kappa = 0.9). Restricting the use of OTC antifungal medications to those individuals with vaginitis symptoms and vaginal pH < or = 4.5 significantly reduced inappropriate use by approximately 50%, Fisher's exact test, p-value = 0.018. Conversely, seeking healthcare provider assessment with vaginal pH > 4.5, leads to correct diagnosis of vaginitis. CONCLUSIONS: The vaginal pH device can be used as an OTC diagnostic tool by consumers when a vaginal infection is suspected. Vaginal pH readings would direct patients whether to purchase an antifungal medication or seek professional diagnosis from a healthcare provider. Understanding and use of this vaginal pH device could reduce inappropriate use of OTC antifungal medications by approximately 50% and improve the correct diagnosis of vaginitis.