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The role of physician characteristics in clinical trial acceptance: testing pathways of influence.

Eight videotaped vignettes were developed that assessed the effects of three physician-related experimental variables (in a 2 x 2 x 2 factorial design) on clinical trial (CT) knowledge, video knowledge, information processing, CT beliefs, affective evaluations (attitudes), and CT acceptance. It was hypothesized that the physician variables (community versus academic-based affiliation, enthusiastic versus neutral presentation of the trial, and new versus previous relationship with the patient) would serve as communication cues that would interrupt message processing, leading to lower knowledge gain but more positive beliefs, attitudes, and CT acceptance. A total of 262 women (161 survivors and 101 controls) participated in the study. The manipulated variables primarily influenced the intermediary variables of post-test CT beliefs and satisfaction with information rather than knowledge or information processing. Multiple regression results indicated that CT acceptance was associated with positive post-CT beliefs, a lower level of information processing, satisfaction with information, and control status. Based on these results, CT acceptance does not appear to be based on a rational decision-making model; this has implications for both the ethics of informed consent and research conceptual models.

Breast Neoplasms↗

Acceptability of Norplant at a well-woman clinic in Turkey.

OBJECTIVE: To make an assessment of the acceptability and cost of subdermal implants, a new method in Turkey, in a free-choice environment. METHODS: The records of women attending a university well-woman clinic in Istanbul, Turkey, were analyzed retrospectively. Among other contraceptives registered in the country, the women were offered subdermal contraceptive implants (Norplant) during counselling sessions. The women who chose implants were invited to attend for follow-up three times during the first 12 months and were advised to return annually thereafter. An estimation of cost was performed for Norplant, using the government price of the implant and the wage rates of public-sector staff. An estimation of cost was also performed for oral contraceptives. RESULTS: Among the 5650 women who applied to the Clinic for contraception between 1 January 1995 and 31 December 1998, 274 women decided to use implants, giving an initial acceptance rate of 5.1%. Continuation rates were 91.8%, 71.6% and 42.5% at 12 months, 24 months and 36 months, respectively. There were no pregnancies within the study period. The only demographic characteristic that was positively related to the acceptability of Norplant was younger age. The cost of contraception with Norplant was found to be lower than that for oral contraceptives. CONCLUSION: The high initial acceptance and continuation rates, combined with its high efficacy, make Norplant a valuable tool for Turkey's National Family Planning Program. Contraception with Norplant is also a cost-effective method, at least for the public sector.

Adult↗

The acceptability of self-collected samples for HPV testing vs. the pap test as alternatives in cervical cancer screening.

OBJECTIVE: To explore the acceptability of the self-collection of samples for human papillomavirus (HPV) testing in comparison with that of the Pap test. METHODS: The study population consisted of 1069 women 20 years and older who were eligible for coverage through the Mexican Institute of Social Security (IMSS). These women were randomly selected among participants in a larger study to evaluate the use of HPV testing as an alternative in cervical cancer screening. All participants provided a self-collected vaginal sample for HPV testing according to explicit instructions and underwent a Pap test. Afterwards, each woman was interviewed about her experience and opinion regarding the two procedures. Acceptability was measured by a calculated score based on discomfort, pain, embarrassment, privacy, perception of personal treatment during the Pap test, and understanding of how to perform the self-sampling method. RESULTS: Ninety-three percent of women experienced sufficient privacy with the Pap test, whereas 98% of women reported that privacy with the self-sampling procedure was acceptable. The Pap test consistently provoked more discomfort, pain, and embarrassment than self-sampling. Sixty-eight percent of the women who indicated a test preference chose self-sampling. Preference for this method was positively associated with monthly household income. Women reported a preference for self-sampling because it is more comfortable (71.2%) and causes less embarrassment (55.8%). CONCLUSIONS: Self-sampling is more acceptable than the Pap test and could improve coverage rates of early detection programs. The incorporation of self-collected samples to detect HPV could encourage participation in screening programs among those women who reject the Pap test because of the necessary pelvic examination.

Adult↗

The acceptability of an investigational vaginal microbicide, PRO 2000 Gel, among women in a phase I clinical trial.

PURPOSE: Vaginal microbicides will provide a woman-initiated prevention strategy that could substantially reduce rates of HIV infection. The acceptability of microbicides will greatly influence the use and, hence, effectiveness of such products. In this study, the acceptability of an investigational microbicide, PRO 2000 Gel (Indevus Pharmaceuticals, Inc., Lexington, MA), was assessed, and women's opinions about microbicides and their potential for real world use were gathered. METHODS: Quantitative and qualitative data were collected from 30 U.S. and 33 South African women. All sexually active HIV-uninfected women and all sexually abstinent HIV-infected women participating in this phase I clinical trial stated in a survey that they would use PRO 2000 Gel if they had reason to be concerned about HIV and the product were available. Qualitative data, however, provided insight into the nuances of acceptability ratings. Women rated product safety, ease of use, and positive effects on sexual pleasure among the most important characteristics of acceptable microbicides. RESULTS: Opinions regarding product leakage, contraceptive capability, and the ability to be used without partners noticing, as well as characteristics of the product itself, varied substantially based on the context of sex and perceptions of risk within each individual woman's life. CONCLUSIONS: As microbicide development continues and the first investigational products move into efficacy trials, the needs and preferences of those women who constitute the potential users of microbicides become paramount. Providing woman-initiated microbicides that are safe, easy to use, and pleasurable will be key to the impact these products will have on the AIDS epidemic worldwide.

Administration, Intravaginal↗

Elders' acceptability ratings of behavioral treatments and pharmacotherapy for the management of geriatric behavioral disturbances.

The management of geriatric behavioral disturbances presents a challenge for both caregivers and care receivers. Previously, we have investigated caregivers' and health care professionals' perceptions of the acceptability of behavioral treatments and pharmacotherapy. However, the perceptions of the potential or actual recipients of these interventions are equally important. In this study, vignette methodology assessed elderly individuals' acceptance of two behavioral treatments and one pharmacologic intervention using Kazdin's Treatment Evaluation Inventory. Respondents assigned the highest treatment acceptability ratings to behavioral treatments and the lowest to drug therapy. The place of patient residence described in the vignettes (community or nursing home) mediated treatment acceptability ratings.

Aged↗

Acceptability of the tuberculosis service: scale development.

Health workers require reliable, easily administered and scored measures to evaluate acceptability of a health service. A 13-item attitude scale was developed to determine acceptability of the tuberculosis (TB) service. The objectives of this study were to: ascertain reliability (internal consistency) of the scale and confirm, through factor analysis, that acceptability of the TB service was based on cognitive and affective reactions. The sample comprised 487 black adult interviewees (67 TB patients on ambulatory therapy and 420 non-TB community members) from two urban townships in the Transvaal, South Africa. The reliability coefficient revealed a high level of internal consistency for the scale (r = 0.84). A principal components analysis, with orthogonal and oblique rotations, was conducted. Two factors accounted for 45.4% of the variance. The highest loadings on Factor I involved an empathic dimension (friendly, helpful, encouraging and communicative). Factor II tended to focus on the organizational elements of the system, such as availability, consistency of information, length of waiting time and maintenance of contact. It was concluded that this scale was a reliable, easily administered and scored measure of acceptability, with underlying affective and cognitive components.

Adult↗

Is screening for tuberculosis acceptable to immigrants? A qualitative study.

BACKGROUND: Screening of immigrants has been a widespread response to the global resurgence of tuberculosis but has been criticized as discriminatory and stigmatising. Acceptability is an essential but neglected ethical prerequisite of screening programmes, particularly those targeting vulnerable groups such as refugees. No data exist concerning acceptability of tuberculosis screening. We therefore examined the responses of immigrants to screening for tuberculosis in a range of settings. METHODS: We carried out a qualitative interview study of a maximum diversity sample of 53 immigrants offered screening for tuberculosis in east London. We recruited people screened in three settings: a social service centre for asylum seekers, a hospital clinic for new entrants and primary care. We confirmed validity of our findings at a focus group of asylum seekers. RESULTS: The opportunity to be screened for tuberculosis was valued highly by recipients. Moreover, many saw being screened as a socially responsible activity. Of the minority raising concerns, few mentioned the possibility of discrimination. Acceptability was high irrespective of setting, with respondents expressing preference for their chosen place of screening. CONCLUSION: Screening for tuberculosis was highly acceptable to recipients in these settings. Screening should be offered in a range of settings.

Adolescent↗

Field acceptability and effectiveness of the routine utilization of zidovudine to reduce mother-to-child transmission of HIV-1 in West Africa.

OBJECTIVE: To ascertain the field acceptability and effectiveness of the routine utilization of zidovudine in reducing mother-to-child transmission (MTCT) of HIV in breastfed children after a randomized clinical trial demonstrated its efficacy in Côte d'Ivoire and Burkina Faso. METHODS: Pregnant women aged 18 years or older, who had confirmed HIV-1 infection, haemoglobinemia greater than 7 g/dl were enrolled in an open label cohort at 36-38 weeks' gestation to receive an oral short course of zidovudine. Paediatric HIV infection was defined as a positive HIV-1 polymerase chain reaction, or if aged 15 months or older, a positive HIV serology. RESULTS: The acceptability of HIV pretest counselling was significantly higher in the cohort (90.3%) than in the trial (83.7%) (P < 0.001), but the return rate for HIV test results and for inclusion was low. A similar proportion of women accepted starting zidovudine in the cohort, 30.4% compared with 27.3% in the trial (P = 0.13). The proportions of women who took more than 80% of the expected zidovudine regimen were 81.8% before labour, 86.7% during labour, and 88.1% during the postpartum period, compared with those observed during the trial, 78.1, 81.1, and 85%, respectively. The MTCT probability at age 15 months was 19.6% in the cohort (n = 185) versus 21.2% in the trial (P = 0.52). CONCLUSION: The major drawback with the implementation of a short zidovudine regimen to reduce MTCT is HIV counselling and testing procedures. For women who consent, zidovudine is well accepted and efficacious under routine circumstances.

Adolescent↗

Acceptance and adherence with antiretroviral therapy among HIV-infected women in a correctional facility.

We examined attitudinal and demographic correlates of antiretroviral acceptance and adherence among incarcerated HIV-infected women. Structured interviews were conducted with 102 HIV-infected female prisoners eligible for antiretroviral therapy. Three quarters of the women were currently taking antiretroviral agents, of whom 62% were adherent to therapy. Satisfaction was very high with the HIV care offered at the prison; 67% had been first offered antiretroviral agents while in prison. Univariate and multivariate analyses showed acceptance of the first offer of antiretroviral therapy to be associated with trust in medication safety, lower educational level, and non-black race. Current acceptance of therapy was associated with trust in the medication's efficacy and safety. Medication adherence was correlated with the patient-physician relationship and presence of emotional supports. Nearly one half of these HIV-seropositive women were willing to take experimental HIV medications in prison. This was correlated with satisfaction with existing health care, the presence of HIV-related social supports, and perceived susceptibility to a worsening condition. Acceptance and adherence with antiretroviral agents appear to be significantly associated with trust in medications, trust in the health care system, and interpersonal relationships with physicians and peers. Development of models of care that encourage and support such relationships is essential for improving adherence to antiretroviral therapy, especially for populations that have historically been marginalized from mainstream medical care systems.

Adult↗

Acceptance for preventive genetic testing and prophylactic surgery in women with a family history of breast and gynaecological cancers.

The fear of family members of patients with breast or gynaecologic cancer of developing a similar disease is often high. We investigated the acceptance for genetic testing of untested women with a positive family history and their attitude for prophylactic surgery. A total of 659 women with a familial history of breast or gynaecologic cancer were asked to answer a questionnaire regarding their interest in genetic testing for breast cancer as well as for gynaecologic carcinoma and their interest in prophylactic surgery. Genetic testing is seen to be accepted by the majority of participants: 85.0 and 77.8% chose a genetic test for breast and gynaecologic cancer, respectively. Prophylactic surgery was much less chosen; prophylactic mastectomy as well as prophylactic hysterectomy or bilateral prophylactic oophorectomy was an option only for a minority of women. Genetic testing for risk assessment of healthy women with a positive family history was observed to be accepted by a majority of participants. Prophylactic surgery was an option only for a minority and was not acceptable for most of the women.

Adult↗

Understanding and overcoming barriers to human papillomavirus vaccine acceptance.

New vaccines designed to prevent human papillomavirus (HPV) infection have the potential to reduce the incidence of serious illness and death worldwide among women, substantially reduce the emotional suffering associated with abnormal Papanicolaou (Pap) test results and the diagnosis of cervical cancer, and save significant health care dollars. However, these benefits may not be fully realized until the vaccine is accepted by patients, parents, and health care practitioners. Furthermore, there may be unique issues related to the acceptance of a vaccine designed to prevent a sexually transmitted infection that is poorly understood by many women. Among the acceptance issues are: individual comfort with a sexually transmitted infection (STI) vaccine; parental comfort with vaccination of their preadolescent/early adolescent daughters; physician comfort with recommending a human papillomavirus vaccine to women and parents of preadolescents; and physician communication skills related to talking with women and parents about the vaccine. Potentially difficult as it might be to implement a vaccination program, vaccination and prevention of HPV-associated disease are still infinitely preferable to observation and treatment. This article will review some of the potential barriers to HPV Vaccine acceptance, with a particular focus on factors relevant to female patients, parents, and health care providers.

Adolescent↗

Safety, acceptability, and potential efficacy of a topical penile microbicide wipe.

Innovative, low-cost, and acceptable measures are needed to reduce sexually transmitted infections (STIs) including HIV. Use of a topical microbicide wipe for penile cleaning before and after sex might be effective in preventing STIs. However, evaluation of this simple method has not been done. Two studies were conducted in Malawi to determine the safety, acceptability, and potential efficacy of a benzalkonium chloride topical penile microbicide wipe. The first study was a phase 1 dose-escalating clinical trial among low-risk circumcised or uncircumcised HIV-negative men. The second study was a pilot before-after efficacy study among uncircumcised HIV-negative or -positive men. In the first study 24 circumcised and 27 uncircumcised men were enrolled. During the entire study period, 18 adverse events (AEs) were reported, and 3 AEs were confirmed by physical examination. Acceptability concerns did not increase with dose escalation, and adherence to use of the wipe ranged from 89%-95%. In the second study, 27 men were enrolled. Gram stain and culture tests showed significant reductions in frequency of several organisms after use of the wipe, including STI-associated bacteria. This penile wipe is safe, acceptable, and can decrease the frequency of penile colonization with microorganisms. The clinical relevance remains to be determined in larger clinical trials.

Adolescent↗

Safety and acceptability of the candidate microbicide Carraguard in Thai Women: findings from a Phase II Clinical Trial.

OBJECTIVE: To determine the safety and acceptability of vaginal application of Carraguard, a carrageenan-derived candidate microbicide gel. DESIGN: A randomized, placebo-controlled, triple-blinded clinical trial was conducted in Chiang Rai, northern Thailand. METHODS: Women were asked to insert one applicator of study gel vaginally at least three times per week (with or without sex) and to use gel with condoms every time they had sex. Safety was assessed by visual inspection of the vagina and cervix, changes in vaginal flora and self-reported symptoms at day 14, month 1 and then monthly for up to 1 year. Acceptability was assessed through reported use of the gel, return of used and unused applicators, and quarterly interviews. RESULTS: One hundred sixty-five women were randomized: 83 to Carraguard and 82 to the placebo (methylcellulose gel) group. Study gel use was similarly high in both groups throughout the trial with an average of four applicators per week. Carraguard use was not associated with abnormal genital clinical findings, abnormal vaginal flora, Pap smear abnormalities or other abnormal clinical signs or symptoms. Adverse events were mostly mild, not attributed to gel use, and similarly distributed between groups. Participants in both groups reported high acceptability. CONCLUSIONS: Carraguard can safely be used an average of four times per week with or without sex and is acceptable to Thai women. A Phase III efficacy trial of Carraguard is warranted and is currently ongoing in South Africa.

Administration, Intravaginal↗

A study of patients' acceptance towards vaginal birth after caesarean section.

Patients' acceptance towards vaginal birth after Caesarean section (VBAC) was studied in 99 women with previous Caesarean section. Their attitude was strongly related to the chance of success of VBAC. Only 53.3% of patients would accept VBAC if they were told that the chance of success was 70%. A history of vaginal delivery and a negative feeling towards previous operation were positively associated with acceptance of VBAC (p < 0.01), while convenience of elective Caesarean section and fear of vaginal delivery (even although most of them had had no vaginal delivery before) were the commonest reasons for refusal. The major caused of a negative feeling towards the previous Caesarean section were postoperative pain and a long recovery period. There was no significant negative effect on acceptance of VBAC if the previous Caesarean section was performed as an emergency operation for slow progress of labour or cephalopelvic disproportion.

Adult↗

Acceptability to patients of a home hospital.

OBJECTIVE: To examine the acceptability to older patients of receiving care in the home for acute medical conditions that require hospital level care by current standards. DESIGN: Interviews with patients during hospitalization regarding their views of a hypothetical "home hospital." PARTICIPANTS: Patients (n = 87) admitted to a community-based academic medical center with a primary diagnosis of pneumonia, congestive heart failure, or chronic obstructive airway disease, their nurses (n = 111), and resident physicians (67). MEASUREMENTS: A questionnaire was developed to measure several domains of acceptability and expectations for care. RESULTS: A majority of patients agreed that treatment in a home hospital would be more comfortable compared with treatment in a hospital (78.5%), would be less likely to result in an infection (62.5%), and would not be a burden to their family (71.8%). There was less certainty that medical care at home can be as good as in the hospital (56.9%). Nearly three-quarters (72.3%) of patients would choose home hospital if it were available. CONCLUSION: Patients may be ready to accept home hospital as an alternative for acute care. The acceptability of home hospital to acutely ill older patients is a critical factor in the development of this alternative for care and has the potential for improving satisfaction with care, reducing complications, hastening return to function, and, possibly, of lowering costs of care.

Acute Disease↗

Methyl-accepting chemotaxis protein III and transducer gene trg.

A comparison of the two-dimensional gel patterns of methyl-3H- and 35S-labeled membrane proteins from trg+ and trg null mutant strains of Escherichia coli indicated that the product of trg is probably methyl-accepting chemotaxis protein III. Like the other known methyl-accepting chemotaxis proteins, the trg product is a membrane protein that migrates as more than one species in sodium dodecyl sulfate-polyacrylamide gel electrophoresis, implying that it too is multiple methylated. It appears likely that all chemoreceptors are linked to the tumble regulator through a single class of membrane protein transducers which are methyl-accepting proteins. Three transducers are coded for by genes tsr, tar, and, probably, trg. Another methyl-accepting protein, which is not related to any of these genes, was observed.

Bacterial Proteins↗

Effects of glutamines and glutamates at sites of covalent modification of a methyl-accepting transducer.

Chemotactic transducer proteins of Escherichia coli contain four or five methyl-accepting glutamates that are crucial for sensory adaptation and gradient sensing. Two residues arise from posttranslational deamidation of glutamines to yield methyl-accepting glutamates. We addressed the significance of this arrangement by creating two mutated trg genes: trg(5E), coding for a transducer in which all five modification sites were synthesized as glutamates, and trg(5Q), in which all five were glutamines. We found that the normal (3E,2Q) configuration was not an absolute requirement for synthesis, assembly, or stable maintenance of transducers. Both mutant proteins were methylated, although Trg(5Q) had a reduced number of methyl-accepting sites because two glutamines at adjacent residues were blocked for deamidation and thus could not become methyl-accepting glutamates. The glutamine-glutamate balance had striking effects on signaling state. Trg(5E) was in a strong counterclockwise signaling configuration, and Trg(5Q) was in a strong clockwise signaling induced by ligand binding, and alanines substituted at modification sites had an intermediate effect. Chemotactic migration by growing cells containing trg(5E) or trg(5Q) exhibited reduced effectiveness, probably reflecting perturbations of the counterclockwise/clockwise ratio caused by newly synthesized transducers not modified rapidly enough to produce a balanced signaling state during growth. These defects were evident for cells in which other transducers were not available to contribute to balanced signaling or were present at lower levels than the mutant proteins.

Bacterial Proteins↗

Acceptability of capillary point-of-care testing: a systematic review.

OBJECTIVE: To identify and synthesise evidence on the acceptability and perceived experience of finger-prick point-of-care testing (POCT) among patients and clinicians across healthcare settings. DESIGN: Systematic review conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020) guidelines. DATA SOURCES: Medline, Embase, PsycInfo, CINAHL, Cochrane and Web of Science were searched from inception to January 2024 and re-run in July 2025, supplemented by citation tracking of relevant studies. ELIGIBILITY CRITERIA: Studies reporting patient and clinicians' experiences, perceptions, satisfaction or acceptability relating to finger-prick POCT for any health condition or blood parameter were eligible. Quantitative, qualitative and mixed-methods designs were included. DATA EXTRACTION AND SYNTHESIS: Data were extracted independently by two reviewers and synthesised using thematic analysis and narrative synthesis. Methodological quality was appraised using the Mixed-Methods Appraisal Tool. RESULTS: 21 studies met the inclusion criteria, encompassing 9128 participants (17 quantitative, 3 qualitative, 1 mixed methods). Across diverse clinical contexts, finger-prick POCT was reported as generally acceptable, less distressing and perceived as a convenient alternative to venous sampling in comparative studies. Thematic synthesis identified two major themes: (1) enhancing the patient-clinician relationship through improved engagement, communication and understanding of care and (2) clinical implications of finger-prick POCT on clinicians' workflow, confidence and skill acquisition. Finger-prick POCT was perceived to promote personalised consultations, enable immediate discussion of results and streamline decision-making. Clinicians highlighted its potential to expand task sharing, improve efficiency and strengthen continuity of care, although concerns regarding training, reliability and quality assurance were identified. CONCLUSIONS: Finger-prick POCT is generally acceptable to patients and clinicians, improving comfort, convenience, engagement and perceived efficiency. Implementation should prioritise training, infrastructure and quality assurance frameworks to maximise clinical and experiential benefits. PROSPERO REGISTRATION NUMBER: CRD42024512130.

Humans↗