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[Participation refusal by probands in an epidemiologic long-term study--sociodemographic, clinical and psychometric findings].

Usually little is known about probands who participated in an epidemiological longitudinal field survey but refused participation in follow-up investigations. For reasons of data protection and on account of the fact that investigative instruments used in longterm field surveys or panel studies are more focused on well defined issues (opinions, attitudes, assessment of behaviors) and less on personality variables, differentiated statements on probands who explicitly refused cooperation can hardly be made. In our epidemiological longitudinal field study on prevalence and course of psychogenic disorders we have a different situation. Within the limits of our study we had the unique opportunity to gain far-reaching information on probands who refused to participate in preceding investigations in regard to sociodemographic, psychometric and clinical variables. The clientele of refusers we present in our paper mainly comprises elderly, married, rather obsessive-compulsive structured, lower-class females. According to our data interactive aspects are equally responsible for reduced cooperativeness. The significance of our findings for the planning and carrying out of epidemiological longitudinal field surveys is discussed.

Adult↗

Pretreatment attrition in a comparative treatment outcome study on panic disorder.

OBJECTIVE: Whereas the fact of attrition during the course of treatment is well documented, little is known about the factors that affect sample selection before the beginning of a study ("pretreatment attrition"). The present study reports on the degree and sources of pretreatment attrition at two sites of a multicenter study on panic disorder that compared treatment outcomes for imipramine and cognitive behavior therapy. METHOD: Data were collected at two clinical research sites, one with a pharmacological treatment orientation (N = 420) and one with a psychosocial treatment orientation (N = 208). RESULTS: The main source of pretreatment attrition was participant refusal. At both research sites, eligible patients most often refused participation because they were either unwilling to start treatment with imipramine (30.6% and 47.4%, respectively) or discontinue their current medication (22.6% and 35.1%, respectively). CONCLUSIONS: Results from comparative treatment outcome studies are limited not only to people who meet the study criteria but also to those who are willing to begin a medication treatment and discontinue their current medication.

Adolescent↗

Participants and refusers in a telephone interview about hormone replacement therapy were equally likely to be taking it.

OBJECTIVE: To address a major concern in pharmacoepidemiology studies related to whether the characteristics of responders are different from those who refuse to participate. STUDY DESIGN AND SETTING: We compared utilization of postmenopausal hormone replacement therapy (HRT) in women who agreed to participate in a telephone interview on HRT utilization and in women who refused to participate in the telephone interview. Information on HRT utilization among responders and refusers was independently available to us from a claims database (the Healthcare Management Alternatives, HMA, in Philadelphia), showing drugs dispensed to these patients. RESULTS: Out of a random sample of 213 women selected from the claims database whom we contacted, 154 (72.3%) women agreed to participate and 59 (32.7%) women refused. Among the 154 women who agreed to participate, 79 (51.3%, 95% CI: 43.1-59.4%) were shown by the database to have been dispensed an HRT during the 15-month period January 1995 through March 1996. Among the 59 women who refused to participate, 30 (50.8%, 95% CI: 37.5-64.1%) were shown by the database to have been dispensed an HRT during the same period. CONCLUSION: Thus, we have evidence that use of HRT was almost identical in responders and nonresponders.

Estrogen Replacement Therapy↗

Research in home-care telemedicine: challenges in patient recruitment.

This study reports challenges in recruiting patients for a randomized controlled trial of homecare telemedicine. Descriptive statistics on patient eligibility for home-care telemedicine services and patient refusals for participation are provided. Frequency counts of reasons for study exclusion and participant refusal and Chi-square tests to compare race and age-related differences are given. Of 302 home-care patients reviewed, 197 (65.2%) did not meet inclusion criteria. The most common reasons for study exclusion were patients either needing <2 visits per month (n = 59, 30%) or >3 skilled nurse visits per week (n = 46, 23.4%). Of the eligible patients (n = 105), 79 persons (75.2%) refused participation. The most common reasons for refusals were lack of perceived addition benefit of telemedicine (n = 27, 34.2%), and that routine health care was sufficient (n = 23, 29.1%). Higher than expected proportions of patients did not meet chosen eligibility criteria or refused to participate. These results should be helpful in designing home-care telemedicine programs and clinical trials.

Aged↗

Reimbursement for pediatric diabetes intensive case management: a model for chronic diseases?

OBJECTIVE: Current reimbursement policies serve as potent disincentives for physicians who provide evaluation and management services exclusively. Such policies threaten nationwide availability of care for personnel-intensive services such as pediatric diabetes. This report describes an approach to improving reimbursement for highly specialized, comprehensive pediatric diabetes management through prospective contracting for services. The objective of this study was to determine whether pediatric diabetes intensive case management services are cost-effective to the payer, the patient, and a pediatric diabetes program. METHODS: A contract with a third-party payer was created to reimburse for 3 key pediatric diabetes intensive case management components: specialty education, 24/7 telephone access to an educator (and board-certified pediatric endocrinologist as needed), and quarterly educator assessments of self-management skills. Data were collected and analyzed for 15 months after signing the contract. Within the first 15 months after the contract was signed, 22 hospital admissions for diabetic ketoacidosis (DKA) occurred in 16 different patients. After hospitalizations for DKA, all 16 patients were offered participation in the program. All were followed during the subsequent 1 to 15 months of observation. Ten patients elected to participate, and 6 refused participation. Frequency of rehospitalization, emergency department visits, and costs were compared between the 2 groups. RESULTS: Among the 10 participating patients, there was only 1 subsequent DKA admission, whereas among the 6 who refused participation, 5 were rehospitalized for DKA on at least 1 occasion. The 10 patients who participated in the program had greater telephone contact with the team compared with those who did not (16 crisis-management calls vs 0). Costs (education, hospitalization, and emergency department visits) per participating patient were approximately 1350 dollars less than those for nonparticipating patients. Differences between participating and nonparticipating groups included age (participants were of younger age), double-parent households (participants were more likely to be from double parent households), and number of medical visits kept (participants kept more follow-up visits). No differences in duration of diabetes, months followed in the program, sex, or ethnicity were observed. CONCLUSIONS: Contracting with third-party payers for pediatric diabetes intensive case management services reduces costs by reducing emergency department and inpatient hospital utilizations, likely a result of intensive education and immediate access to the diabetes health care team for crisis management. Such strategies may prove to be cost saving not only for diabetes management but also for managing other costly and personnel-intensive chronic diseases.

Adolescent↗

Patients' refusal to participate in clinical research.

The number of protocol-eligible patients, refusing to participate in a clinical trial is often not mentioned. The aim of this study is to report the number of refusers and to evaluate the reasons for not participating in a clinical study concerning post-operative pain relief and to assess the potential influence on the final study results. Patients refusing to participate in the study were recorded and evaluated for reasons of refusal. The post-operative pain relief techniques applied in this trial are commonly used, but nevertheless the refusal rate was higher than expected. When it was mentioned that an epidural technique was a part of the trial, 16.7% of the total protocol-eligible group refused. The responses of those offered an epidural could be divided into two groups: the adamant pros and cons to this technique. It can be concluded that in order to be able to judge the validity of results and thus for good clinical practice, the number of patients refusing to participate in a clinical trial and their reasons, should be mentioned in all publications.

Analgesia, Epidural↗

External validity of a randomised clinical trial of temporomandibular disorders: analysis of the patients who refused to participate in research.

PURPOSE: To assess the external validity of a randomised clinical trial (RCT) of a painful condition. METHOD: Consecutive patients with painful temporomandibular disorders (TMDs) were invited to participate in a clinical trial. Patients who refused to participate were compared to those who agreed to participate in this study with respect to degree of symptoms at time of presentation. RESULTS: The patients who refused to participate had more pain, and their condition interfered more with their daily life than those who accepted the invitation to participate. CONCLUSION: Selection bias in RCTs of painful conditions can skew the results, and external validity should be analysed before the results are generalised.

Activities of Daily Living↗

Seizures in the elderly: etiology and prognosis.

PURPOSE: To determine the etiology, early mortality, predictors of prognosis and diagnostic yields of EEG and CT scans of the head in new-onset seizures in elderly patients. METHODS: EEG records for the north-central region of Saskatchewan, between 01/94 and 12/95 were reviewed to identify all adults aged 60 years or older with new-onset seizures. Information on demographics, seizure type, etiology, EEG and neuroimaging studies, anti-epileptic treatment and course of epilepsy was obtained by review of medical records and interview with the patient and/or family member. RESULTS: Of 88 eligible subjects, 61 (69%) were contacted for follow-up, 19 (22%) were deceased (12 of whom who had a serious underlying etiology to their seizures, which was obvious at the time of initial presentation and led shortly to their demise), 4 (5%) were lost to follow-up and 4 (5%) refused participation. Excluding those refusing participation, 74/84 (88%) patients presented with partial or secondarily generalized seizures. Seizures were cryptogenic in 38/84 (45%), and due to stroke in 19/84 (23%). EEGs were abnormal in 61/84 (73%) cases, with epileptiform discharge in 33/84 (39%). CT scans were abnormal in 57/84 (68%) cases with acute pathology in 29/84 (35%). Of the 61 patients participating in the follow-up interview, 54 (89%) were treated with anti-epileptic medication and seizure control was usually successful. Predictors for ongoing seizures were more than 3 seizures at presentation, epileptiform activity on initial EEG and discontinuation of anti-epileptic medication for lack of efficacy. CONCLUSION: Prognosis of new-onset seizures in elderly patients is favorable if seizures are not symptomatic of a life-threatening disorder.

Aged↗

A follow-up comparison of study participants and refusers within a rural elderly population.

BACKGROUND: Survey rates are known to decline with age. Survey results can be affected by response bias if nonresponders are more, or less, likely than participants to suffer from the condition being studied. For instance, it is possible that older adults with dementia would be less likely to participate in a study of dementing disorders. METHODS: A random sample of a rural U.S. population aged 65+ years yielded 1,422 participants and 912 refusers in addition to others who were ineligible, inaccessible, or untestable. Participants and refusers were compared on age, sex, 5-year mortality, and causes of death suggestive of dementia as listed on death certificates. RESULTS: Compared to participants, refusers were significantly older and more likely to be women, with mortality similar to that of participants at approximately 5-year follow-up. Death certificate data revealed no significant differences in reported causes of death indicating or suggesting dementia. CONCLUSIONS: In this population, those who refused to participate in a dementia survey were not more likely to be ill or demented than those who did participate.

Aged↗

Predictors of refusal to participate: a longitudinal health survey of the elderly in Australia.

BACKGROUND: The loss of participants in longitudinal studies due to non-contact, refusal or death can introduce bias into the results of such studies. The study described here examines reasons for refusal over three waves of a survey of persons aged >or=70 years. METHODS: In a longitudinal study involving three waves, participants were compared to those who refused to participate but allowed an informant to be interviewed and to those who refused any participation. RESULTS: At Wave 1 both groups of Wave 2 non-participants had reported lower occupational status and fewer years of education, had achieved lower verbal IQ scores and cognitive performance scores and experienced some distress from the interview. Those with an informant interview only were in poorer physical health than those who participated and those who refused. Depression and anxiety symptoms were not associated with non-participation. Multivariate analyses found that verbal IQ and cognitive impairment predicted refusal. Results were very similar for refusers at both Waves 2 and 3. CONCLUSIONS: Longitudinal studies of the elderly may over estimate cognitive performance because of the greater refusal rate of those with poorer performance. However, there is no evidence of bias with respect to anxiety or depression.

Activities of Daily Living↗

Response to mail surveys: effect of a request to explain refusal to participate. The ARIC Study Investigators.

As part of a mailed health survey, we investigated the effect on the response rate of a request to explain refusal to participate. Subjects (N = 1,240) were randomized either to receive or not to receive, with the first mailing, a letter requesting an explanation of their decision not to fill out the questionnaire, if they chose that option. There was a slightly higher cumulative response during most of the study from subjects who had been sent the request, but little difference between the two study groups in the ultimate response rate [80% from the intervention group vs 83% from the control group; response rate difference = -3%; 95% confidence limits (CL) = -7%, 1%]. Of 209 individuals who were sent the request and did not return the questionnaire, only 15 (7%) sent back an explanation. A request to explain a refusal to participate in a mail survey neither jeopardized the response rate nor enhanced it.

Cooperative Behavior↗

A study of women who refused to participate in a community survey of psychiatric disorder.

The bias resulting from nonresponse causes problems for all epidemiological research. This study investigated the characteristics of those who refused to participate in a community survey of female psychiatric disorder. The demographic characteristics of refusers were similar to those previously reported. When compared to responders, those who refused tended to be older, never married and not widowed, of lower socioeconomic status and urban dwellers. No differences in physical illness requiring hospitalization or inpatient and outpatient psychiatric illness, as assessed through hospital records, were discerned between refusers and responders. Reasons for refusal are discussed. The bias problem may get worse as changing community attitudes to privacy and patients' rights lead to greater refusal rates.

Cross-Sectional Studies↗

Characteristics of adolescents who provide neither parental consent nor refusal for participation in school-based survey research.

Schools offer a convenient setting for research on adolescents. However, obtaining active written parental consent is difficult. In a 6th-grade smoking study, students were recruited with two consent procedures: active consent (parents must provide written consent for their children to participate) and implied consent (children may participate unless their parents provide written refusal). Of 4,427 invited students, 3,358 (76%) provided active parental consent, 420 (9%) provided active parental refusal, and 649 (15%) provided implied consent (parental nonresponse). The implied consent procedure recruited more boys, African Americans, students with poor grades, and smokers. This dual-consent procedure is useful for collecting some limited data from students who do not provide active consent or refusal.

Adolescent↗

Predictors of patient refusal to participate in ambulatory-based comprehensive geriatric assessment.

BACKGROUND: Comprehensive Geriatric Assessment (CGA) in ambulatory settings can be effective only if patients who need this intervention are willing to participate in the evaluation and follow the indicated therapy. METHODS: To learn whether older persons' health beliefs and perceptions influence participation in ambulatory-based CGA, we studied subjects who failed a screening assessment offered through a community-based outreach program and were deemed appropriate for CGA. All subjects were interviewed in person following a structured sequence including questions from the RAND Current Health (CH) and Health Worry/Concern (HWC) scales, the Health Locus of Control Scale (HLC), and scales developed to measure health risks and perceived benefits of geriatric assessment. RESULTS: In univariate analysis, the following variables were associated with refusal to participate in CGA status at the p < .05 level: increased worry on HWC and higher scores on three new scales constructed to measure Global Health Risk (GHR), Perceived Global Health Benefits (PGHB), and Perceived Specific Health Benefits (PSHB). For GHR, higher scores indicate greater risk; for PGHB and PSHB, higher scores indicate greater perceived benefit. In multivariate analysis, only educational level, GHR, PGHB, and PSHB scores were independently predictive of refuser status. Correlations with other established health perceptions scales provided support that global health risk and perceived global and specific health benefits are unique constructs. Furthermore, high scores on these scales predicted participation in health improvement programs. CONCLUSIONS: Patients' beliefs about perceived risk and benefit can be measured and predict willingness to participate in ambulatory-based CGA.

Aged↗

Rates of refusal to participate in research studies among men and women.

Studies have indicated that, among persons with serious mental illness, women may be less likely to participate in clinical research studies than men. This study examined refusal rates by gender in four recent studies that included persons with a range of diagnoses and that used various interventions and methods. Examination of the four studies indicated that women are no more likely than men to decline to participate in studies but that women may be underrepresented in target populations. When feasible, oversampling may be useful to increase the participation of women or of any other underrepresented demographic group in research studies.

Adult↗

Psychological measures: reliability in the assessment of stroke patients.

OBJECTIVE: To determine whether acute stroke patients can give reliable responses to standardized psychological measures. DESIGN: Survey design with retrospective review of Neurobehavioral Cognitive Status Examination (NCSE) scores. SETTING: A rehabilitation hospital in Philadelphia. PATIENTS: 106 consecutive admissions to stroke services at a rehabilitation hospital were evaluated according to the following inclusion criteria: Patients at least 65 years of age, English speaking, having a documented history of cerebrovascular accident (CVA), possession of receptive speech comprehension, and the ability to maintain attention adequate for participation in the study interview. Of the 47 eligible for participation, 10 patients refused participation and 13 were discharged before the interview could be completed. Thus 24 patients were interviewed, with one patient unable to complete the second half of the interview. MAIN OUTCOME MEASURES: In phase 1, the patient's performance on a structured interview (including the Multidimensional Health Locus of Control Scales (MHLC), Life Orientation Test (LOT), and Center for Epidemiological Studies Depression Scale (CES-D) scales) produced a Total Reliability Score, indicating the overall reliability of the patient's responses. In phase 2, NCSE scores were examined (retrospectively) for their ability to predict the patient's Total Reliability Score on the structured interview. RESULTS: Using Total Reliability Scores, 9 patients were categorized as "passing," 9 were categorized as "uncertain," and 5 were categorized as "failing" the interview. The NCSE was predictive for individuals who had a very low likelihood of being able to respond consistently. The NCSE failed to identify which individuals would respond in a reliable fashion. CONCLUSIONS: It is both possible and important to assess response reliability when using psychological measures soon after stroke. Future research will need to document other potential predictors of interview performance, including combinations of NCSE subscales.

Aged↗

Comparing participants and nonparticipants recruited for an effectiveness study of nicotine replacement therapy.

BACKGROUND: Interventions for smoking cessation have been typically evaluated on reactively recruited samples in clinical trials (efficacy trials). However, to have an impact on smoking rates in a general population, the intervention should also be evaluated with proactively recruited representative samples (effectiveness trials). PURPOSE: The characteristics of participants and two groups of nonparticipants recruited for a population-based nicotine replacement therapy study were compared. METHODS: All members of a large New England Veterans' Administration Medical Center were contacted, and interviews were completed with 3,239 identified smokers (at least 10 cigarettes per day). At the end of the interview, all smokers were offered participation in a multiple intervention study. Of the interviewed smokers, 2,915 verbally agreed to participate in the study (90%). Of those who gave initial verbal consent, 2,054 returned the written informed consent form and became participants (70%). RESULTS: The participants (full consent group) differed significantly from both nonparticipant groups-that is, the smokers who were interviewed but declined participation by active refusal (survey only group) and those who gave verbal consent but passively refused participation by failing to return the written consent form (verbal consent only group). Participants were more likely to be married, younger, and female; to live with others; and to have previously used or considered using nicotine replacement therapy. The survey only group was also more likely to be in the precontemplation stage (54%), whereas the participants were more likely to be in the contemplation (46%) or preparation stage (35%). The verbal consent only group was intermediate of the other two groups in stage-of-change characteristics. CONCLUSIONS: An important finding was that it is possible to recruit a large proportion of a sample of identified smokers to an nicotine replacement therapy study. However, the participants are likely to differ in significant ways from those who either actively or passively decline participation.

Female↗

Recruitment of adults 65 years and older as participants in the Cardiovascular Health Study.

Few large-scale epidemiologic studies have enrolled older adults; hence, little is known about the feasibility of recruiting this group for long-term population-based studies. In this article we present the recruitment experience of the Cardiovascular Health Study (CHS), a population-based, longitudinal study of cardiovascular diseases in adults 65 years and older. Participants were sampled from the Health Care Financing Administration's (HCFA) Medicare eligibility lists in four US communities. Letters were mailed to 11,955 sampled individuals. Persons recruited were required to complete an extensive home interview and then a 4-hour in-clinic examination. Excluded were persons who were expected to be able to complete the baseline examination and who were not expected to return for the 3-year follow-up. Some 3654 participants were recruited from those randomly selected from the Medicare sampling frame. In addition, 1547 other age-eligible persons living in the household with the sampled individuals also participated, yielding a total of 5201 participants. Of those who were contacted, 9.6% were ineligible and 34.9% refused participation. Among those eligible, 38.6% refused and 57.3% were enrolled (the remaining did not refuse but were not enrolled before the recruitment ended). Data from a subsample indicate that compared to those who were ineligible or who refused, enrolled participants were younger, more highly educated, more likely to be married, and less likely to report limitations in activity. Compared to those who were eligible but refused, enrolled participants were less likely to have high blood pressure and stroke and more likely to have quit smoking and to perceive their health status as very good or excellent.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗