Symposium: ethical considerations in HIV preventive vaccine research: examining the 18 UNAIDS guidance points. The 18 UNAIDS guidance points.
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AIDS Vaccines↗
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Comparative analysis of unaided emmetropic and unaided noncorrected myopic underwater visual acuity.
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Adolescent↗
Speech recognition performance of patients with sensorineural hearing loss under unaided and aided conditions using linear and compression hearing AIDS.
OBJECTIVES: This study compared speech recognition performance on the Northwestern University Auditory Test No. 6 (NU-6) and the Connected Speech Test (CST) for three hearing aid circuits (peak clipping [PC], compression limiting [CL], and wide dynamic range compression [WDRC]) in adults with symmetrical sensorineural hearing loss. The study also questioned whether or not hearing aid benefit for the three circuits was dependent upon the speech level and the signal-to-babble ratio (S/B) and upon the degree and slope of hearing loss. DESIGN: Unaided speech recognition performance for NU-6 and CST materials presented from a loudspeaker at 0 degrees was measured during Visit 1, and both unaided and aided performance was measured at 3-mo intervals during Visits 2 to 4. The NU-6 was presented in quiet at a conversational speech level of 62 dB SPL. The CST was presented in 10 listening conditions-three S/B (-3, 0, and 3 dB) at each of three speech levels (soft speech at 52 dB SPL, conversational speech at 62 dB SPL, and loud speech at 74 dB SPL) and in quiet at 74 dB SPL. Uncorrelated multi-talker babble was presented from two loudspeakers at 45 degrees on each side of the main speaker. Hearing aid benefit was examined for 360 subjects divided into four groups of hearing loss, pure tone average <40 dB HL and slope <10 dB/octave or >10 dB/octave and hearing loss >40 dB HL for the two slope categories. RESULTS: Hearing aid benefit (aided minus unaided performance) measured on the NU-6 in quiet exceeded 31 rau for all three circuits. Although small statistical advantages were found for the WDRC, the differences were approximately 2% and are not considered clinically relevant. Unaided CST performance showed a complex relationship between presentation level and signal-to-babble ratio that was further confounded by the degree of hearing loss. For the two mild hearing loss groups and for each of the three nominal signal-to-babble ratios, CST performance decreased by 20 rau for the -3 dB S/B to 6 rau for the 3 dB S/B as speech level increased from 52 to 74 dB SPL. In contrast, unaided performance increased by 32 to 13 rau with signal level for all signal-to-babble ratios for the two >40 dB hearing loss groups. Overall, aided CST performance exceeded unaided performance for all 10 conditions. As expected, hearing aid benefit was greatest (27 rau) for soft speech and smallest for loud speech (6 rau). Differences among the hearing aid circuits were small with only one significant difference; the WDRC at 62/0 was poorer by 3 rau than the other two circuits. When the CST data were analyzed as a function of hearing loss, five pair-wise comparisons were significant. In contrast to the unaided performance, aided performance for all hearing loss groups decreased as presentation level increased, even though the signal-to-babble ratio was constant. CONCLUSIONS: All three hearing aids circuits provided benefit over the unaided condition in both quiet and noise. The greatest benefit was measured for soft speech in the more severe hearing loss groups. Although only small differences were measured among the three hearing aid circuits, significant differences favored the PC and CL circuits over the WDRC in the mild hearing loss groups and favored the WDRC over the PC in the more severe, sloping hearing loss group. An interesting interaction between speech level, signal-to-babble ratio, degree of hearing loss, and amplification was found. For a constant signal-to-babble ratio, recognition performance decreased as speech level increased from 52 to 74 dB SPL. The effect was most marked in the milder hearing loss groups and in the aided conditions, and occurred at even the lowest speech levels.
Adult↗
Unaided speech in long-term tube-free tracheostomy.
OBJECTIVES/HYPOTHESIS: Objectives of the current study were as follows: 1) to determine whether a self-sustaining, tube-free tracheostomy with unaided speech capability can be achieved, 2) to propose new surgical techniques to enhance voluntary constriction of a tube-free tracheostoma to improve cough and speech production, and 3) to explain the mechanism involved in unaided speech after long-term tracheostomy. The hypotheses were that long-term, tube-free tracheostomy could minimize the unwanted effects of conventional tube-dependent tracheotomy; that surgical shunting of the trachea to the skin surface can be established through a short, skin-lined, self-supporting, nostril-like opening; and that patients could generate speech and cough without the need to occlude the stoma or use stents and/or one-way valves if such a long-term tube-free tracheostoma were established. STUDY DESIGN: A prospective study of tube-free tracheostomy intended to establish unaided cough and speech. METHODS: Thirty-five patients who underwent long-term flap tracheostomies between 1992 and 1999 with the prospective intent of establishing a self-sustaining stoma without the need for tubes or stents were reviewed. The patients were trained to intentionally constrict the stoma for production of unaided speech and cough. The pertinent techniques developed for successful achievement of these characteristics are presented and reviewed. A new surgical technique using a local tendinous muscular sling was designed to further improve the efficacy of stomal constriction. RESULTS: A tube-free stoma was successfully established in all 35 patients. Eighteen patients achieved effective intentional constriction of the stoma and thereby were capable of unaided speech production. Four patients required an additional new surgical sling procedure to optimize unaided cough and speech production. Thirteen patients achieved only limited unaided speech production, but were satisfied to do nothing further. CONCLUSIONS: New surgical techniques and postoperative management to create a modified tube-free tracheostomy with self-constricting capabilities can enable production of effective cough and near-normal generation of unaided speech. In this manner, the airway can be secured with little or no voice compromise.
Adolescent↗
Child sexual abuse--genital tract findings in prepubertal girls. II. Comparison of colposcopic and unaided examinations.
In recent years the inspection of the vulva of sexually abused girls by magnification with a colposcope has become increasingly popular. However, data concerning the usefulness of colposcopy in such evaluations are lacking. In a prospective study, 130 prepubertal girls (mean age 5.5 years) who were identified by child protective agencies to be victims of sexual abuse were evaluated both by an unaided examination and by colposcopy. If the colposcopic findings differed from those of the unaided inspection, the macroscopic examination was repeated to determine whether the abnormality could have been detected without magnification. Altogether, 92 of the 130 girls were found to have abnormal findings. In the majority of girls with abnormalities (96%), the abnormalities were observed during the unaided examination. Of the four patients in whom the findings were detected initially by the colposcopic examination, these findings were observed during the repeat unaided examination. The findings were observed by colposcopic examination alone in only one patient. We conclude that unaided examination is adequate for the evaluation of most victims of sexual abuse.
Child↗
Is the unaided ear effect independent of auditory aging?
As a group, adults with bilateral symmetric sensorineural hearing loss (SNHL) who receive a monaural hearing aid fitting experience a progressive decline in their word recognition score (WRS) for monosyllabic word materials in the unaided ear but not in the aided ear. However, adults with binaural fittings do not demonstrate a similar deterioration in their WRS. In an effort to determine the role of senescent auditory changes on the unaided ear effect, a retrospective investigation was carried out on a group of hearing aid wearers. Using NU-6 to assess the WRS, this investigation attempted to answer the following question: is the unaided ear effect related to asymmetric senescent auditory changes? The present results indicate that the unaided ear effect is not related to such an asymmetric effect since it is shown to occur in adults with SNHL whether in the fourth or seventh decade of life.
Adult↗
Improved methods and assumptions for estimation of the HIV/AIDS epidemic and its impact: Recommendations of the UNAIDS Reference Group on Estimates, Modelling and Projections.
UNAIDS and WHO produce biannual country-specific estimates of HIV/AIDS and its impact. These estimates are based on methods and assumptions that reflect the best understanding of HIV epidemiology and demography at the time. Where significant advances are made in epidemiological and demographic research, the methods and assumptions must evolve to match these advances. UNAIDS established an Epidemiology Reference Group in 1999 to advise them and other organisations on HIV epidemiology and methods for making estimates and projections of HIV/AIDS. During the meeting of the reference group in 2001, four priority areas were identified where methods and assumptions should be reviewed and perhaps modified: a) models of the HIV epidemic, b) survival of adults with HIV-1 in low and middle income countries, c) survival of children with HIV-1 in low and middle income countries, and d) methods to estimate numbers of AIDS orphans. Research and literature reviews were carried out by Reference Group members and invited specialists, prior to meetings held during 2001-2. Recommendations reflecting the consensus of the meeting participants on the four priority areas were determined at each meeting. These recommendations were followed in UNAIDS and WHO development of country-specific estimates of HIV/AIDS and its impact for end of 2001.
Acquired Immunodeficiency Syndrome↗
Gender differences in the outcome of an unaided smoking cessation attempt.
There is conflicting evidence concerning gender differences in success at quitting smoking. Information is especially lacking regarding gender differences among unaided quitters who make up the vast majority of those attempting to quit. One hundred thirty-five smokers who made an unaided attempt at quitting were interviewed before quitting and were followed for 1 year after cessation. Relapse rates were extremely high both for men and women, with 62% of participants returning to regular smoking within 15 days after cessation. Women and men were equally likely to maintain short-term abstinence (through 15 days), but women were more than three times as likely to relapse subsequently. Nine percent of men, but no women, had biochemically verified sustained abstinence throughout the 1-year follow-up period. For both men and women, any smoking after the quit attempt inevitably led to full-blown relapse. Most participants resumed regular smoking within 24 hours after the first episode of smoking. Gender differences were observed for several variables related to smoking history, demographics, social support, perceived stress, and motivational factors, but these differences did not explain the increased risk of relapse for women. Our results clearly indicate that women are less likely than men to maintain long-term smoking abstinence following an unaided quit attempt, but reasons for this gender difference need further exploration.
Adult↗
[The UNAIDS strategy in the prevention of HIV/AIDS in the countries of Eastern Europe].
Grounds for the necessity of the formation of effective approaches to the prevention of HIV epidemic with a view to counteract the rapid spread of infection in East European countries are presented. Attention is specially drawn to fact that the epidemic will not be limited by drug users, but will quickly cross the boundaries of this group. The development of preventive measures must be based on the use of the world experience. New effective approaches to work with vulnerable groups (the strategy of harm reduction, work in communities, consultations, etc.) must be widely used. The program of actions of the UNAIDS European Section, stipulating the strengthening and extension of the potential of the countries in the region for the effective counteraction to the epidemic, is formulated. As priority areas, activities covering vulnerable groups and with young people have been determined. The strategy of UNAIDS is realized through 20 UN theme groups on HIV/AIDS in the countries of Eastern Europe. Special attention is drawn to the creation of methodological networks. The creation of a unified strategic plan for counteraction the epidemic of HIV/AIDS is regarded by UNAIDS as its perspective for the future.
Acquired Immunodeficiency Syndrome↗
Ethical considerations in international HIV vaccine trials: summary of a consultative process conducted by the Joint United Nations Programme on HIV/AIDS (UNAIDS).
Research that is initiated, designed or funded by sponsor agencies based in countries with relatively high social and economic development, and conducted in countries that are relatively less developed, gives rise to many important ethical challenges. Although clinical trials of HIV vaccines began ten years ago in the US and Europe, an increasing number of trials are now being conducted or planned in other countries, including several that are considered "developing" countries. Safeguarding the rights and welfare of individuals participating as research subjects in developing countries is a priority. In September, 1997, the Joint United Nations Programme on HIV/AIDS (UNAIDS) embarked on a process of international consultation; its purpose was further to define the important ethical issues and to formulate guidance that might facilitate the ethical design and conduct of HIV vaccine trials in international contexts. This paper summarises the major outcomes of the UNAIDS consultative process.
AIDS Vaccines↗
Estimation of client-assessed hearing aid performance based upon unaided variables.
The purpose of this study was to investigate the possibility of estimating client-assessed hearing aid performance before hearing aids are purchased. Aided performance was represented by the Profile of Hearing Aid Performance (PHAP, Cox & Gilmore, 1990). Multiple regression was applied to 16 unaided predictor variables and to 8 response variables. The response variables were the scores from the seven PHAP subscales plus the overall PHAP score, which were obtained from 46 participants. Audiologic, demographic, and psychological information was included among the 16 predictor variables. The average widths of 95% prediction intervals showed that, with the exception of the Aversiveness of Sounds and Ease of Communication subscales, PHAP subscale scores were predicted within 15% on average. Eighty percent or more of the individual participants' PHAP scores were predicted within 15% for all but the Aversiveness of Sounds subscale. The predictor variables appearing in regression equations for the greatest number of PHAP subscales include age, Communication Strategies and Personal Adjustment scores from the Communication Profile for the Hearing Impaired (Demorest & Erdman, 1986), Revised Speech Perception in Noise (Bilger, Neutzel, Rabinowitz, & Rzeczkowski, 1984; Kalikow, Stevens, & Elliott, 1977) test scores, comfortable loudness levels, and the difference between National Acoustic Laboratories' target gain (Byrne & Dillon, 1986) and actual insertion gain. Further testing of the models on additional participants would be needed to determine their clinical applicability. In addition to being potentially useful for predicting client-assessed aided performance, the equations obtained in this study identify relationships between the aided and unaided variables that can be applied in the counseling of new hearing aid users.
Aged↗
Unaided speech in tube-free tracheostomy: The supplementary sling procedure.
OBJECTIVE: In some patients after tube-free tracheostomy, air escape hinders voice optimization. Our objective was to determine whether a supplementary sling procedure could reduce air escape and improve unaided speech and cough in these patients. STUDY DESIGN AND SETTING: From September 1998 through June 2001, 12 patients underwent supplementary sling procedures at the Cleveland Clinic. After surgery, stoma constriction and voice production were assessed. RESULTS: Fifteen procedures were performed in 12 patients. Two patients required revision procedures. All 9 patients with sufficient follow-up have markedly improved stoma constriction and speech production. Three patients with less than 3 months' follow-up already show early improvement. CONCLUSION: The supplementary sling procedure effectively reduces air escape and helps unaided speech and cough in patients with tube-free tracheostomata. SIGNIFICANCE: As more patients undergo tube-free tracheostomy, the pool of patients who might benefit from a sling procedure will grow. Indications might extend to postlaryngectomy or post-laryngeal transplant patients.
Adult↗
Study of unaided cross-eyed stereopsis.
The learning of the skill of unaided cross-eyed stereopsis was investigated on a group of young adults. Both pictorial and random-dot stereograms were used; small stereograms were viewed at normal reading distance and large projected stereograms were viewed in an auditorium. The results suggest that this direct stereoscopic technique can be learned within a few minutes by almost everyone in the population represented by the test group. The calculated eye-convergence angles for various conditions of cross-eyed stereoscopic viewing indicate that little eye discomfort is caused by this factor when the stereograms are located at a sufficient distance from the viewers. The comments of subjects support this conclusion. The unexpected prevalence of the aptitude for this skill should have practical application in the unaided three-dimensional visualization of computer-generated stereograms.
Accommodation, Ocular↗
Progression of sensorineural hearing impairment in aided and unaided ears.
The possibility of "adult onset auditory deprivation" has been proposed as a condition of extensive deterioration of speech discrimination in unaided ears. Pure tone thresholds and speech discrimination were studied in a follow-up examination on 500 patients using hearing aids unilaterally. The follow-up time ranged from 5 to 24 years. In average the same amount of deterioration was obtained in both ears. Deterioration in pure tone thresholds increased after the age of 80 years and speech discrimination after 65 years respectively. The results obtained gave no support to the concept of adult onset auditory deprivation in unaided ears.
Aged↗
Use of UNAIDS tools to evaluate HIV voluntary counselling and testing services for mineworkers in South Africa.
HIV voluntary counselling and testing (VCT) is now an integral part of many HIV care and control programmes. However, very little work has been done to assess the quality of VCT services. An evaluation of VCT services for mineworkers in Welkom, South Africa was conducted to assess client and counsellor satisfaction, the quality of the services and to identify barriers to uptake of VCT. A cross-sectional survey was carried out using tools developed by UNAIDS, consisting of semi-structured interviews and observation of counselling sessions. Twenty-two nurse counsellors and six community volunteers were interviewed. Twenty-four counselling sessions were observed and 24 client exit interviews were conducted. Although nine of the 22 nurse counsellors had only in-service rather than formal training for HIV counselling whereas all community volunteers had been formally trained, nurse counsellors demonstrated better interpersonal skills than did community volunteers. Both clients and counsellors identified fear of a positive result as a major barrier to HIV testing. Clients also raised concerns about confidentiality. UNAIDS evaluation tools were a feasible and an acceptable method of assessing VCT in this operational setting. The study identified areas where training needs to be strengthened and suggested ways of improving the services, and changes to the service have now been implemented in line with these recommendations.
Counseling↗
Value of the unaided clinical diagnosis in dyspeptic patients in primary care.
OBJECTIVES: Attempts to establish a clinical diagnosis in dyspeptic patients have generally been unrewarding. However, studies in unselected dyspeptic patients are lacking. The aim of this study was to determine the value of the unaided clinical diagnosis by general practitioners (GP) and by experienced gastroenterologists (GA) in unselected dyspeptic patients in primary care. METHODS: Three hundred forty-seven patients with epigastric pain/discomfort for more than 2 wk who were consulting general practitioners (n = 73), but without alarm symptoms. GPs and GAs gave a provisional diagnosis based on an unstructured interview. All patients underwent endoscopy within 5 days of referral. Validity of the provisional diagnoses was measured using the endoscopic diagnoses as the gold standards. RESULTS: For GPs, the sensitivity of a provisional diagnosis of peptic ulcer was 61% [95% confidence intervals (CI): 46-74%]; for specificity 73%, the 95% CI was 68-78%; and for positive predictive values, it was 28%, the 95% CI was 20-37%. GAs were more reluctant to predict ulcer, leading to a higher specificity: 84% (95% CI: 79-88%), but a similar sensitivity: 55% (95% CI: 40-69%). The GPs were unable to distinguish between functional and organic dyspepsia (chance-corrected overall validity: 9%; 95% CI: 0-18%). GPs and GAs agreed in their provisional diagnosis in only 45% of the patients, in whom the diagnosis was confirmed by endoscopy in 2/3. CONCLUSION: The unaided clinical diagnosis given by the GP and by the GA in dyspeptic patients in primary care is unreliable. Nearly half of patients with ulcer or esophagitis were misclassified, despite a high susceptibility to organic disease. Different patients were problematic for GPs and GAs, which may indicate that most dyspeptic patients do not present with symptoms characteristic of a specific disease.
Adult↗
When the patient chooses: describing unaided decisions in health care.
Patients make health care decisions in a complex and alien environment with little, if any, insightful aid from health care professionals; such professionals may be well intentioned but naive about how to provide decisional support. The search for information is unstructured, and once information is obtained, it is not easily understood by the layperson who may have difficulty understanding ambiguous and uncertain information. This paper addresses issues and concerns pertaining to the representation of unaided decision making in clinical practice among patients in two clinical contexts (breast cancer and cardiovascular disease). An analysis of qualitative clinical interviews provides indicators of naturalistic rule-based approaches patients use when making a medical decision. The relative salience of the alternatives plays a key role in discriminating rapid, intuitive decisions from those that are more deliberative. Empirical descriptions of real-world decision-making processes support a theoretical model of unaided decisions in health care.
Arrhythmias, Cardiac↗
Keratoconus with good unaided visual acuities: two case reports.
BACKGROUND: Ophthalmic evaluation of patients with keratoconus (KC) often reveals highly myopic and irregular astigmatic refractive corrections. Irregular corneal astigmatism and central corneal scarring in patients with KC often result in a loss of best-corrected spectacle acuity. Rigid gaspermeable contact lenses generally optimize visual acuities for patients with KC. CASE REPORTS: Two cases are discussed of patients who manifested clinically diagnosed KC but unusually good unaided Snellen visual acuities (20/25+ or better) in both eyes. CONCLUSION: Good unaided visual acuities are not necessarily inconsistent with the diagnosis of KC.
Adult↗