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PubMed1990

Towards vaccine optimisation.

New molecular technologies have accelerated the search for sub-unit candidate vaccines. However, once identified the use of a candidate antigen must be optimised to reap the maximum benefit from the eventual vaccine. This optimisation should take into account both the needs of the target population, and the various ways of potentiating the protective immune response induced. One must be sure that the final product will be used. Hence, vaccine optimisation should strive toward meeting the needs of a specific epidemiological problem within the economic constraints of a given situation. This may be possible using novel delivery systems designed to limit the number of doses needed, improve the stability or facilitate the delivery of a particular vaccine. In meeting the needs of a target population in a field situation, one must also keep in mind certain safety factors that go beyond the usual regulatory constraints. The immune response to vaccine candidates can be potentiated in many ways. The ability to preferentially induce specific protective effector mechanisms: i.e., antibody isotypes, T-cell subsets, and T-cell sub-subsets, is becoming a reality. Carrier molecules designed to avoid the problems of epitope suppression and competition, and perhaps an eventual "carrier jam," are being developed. Adjuvants and immunostimulants may also help, but the critical issue here remains their acceptability for use in man. Finally novel strategies for the induction of the immune response may also potentiate the immune response in the optimisation of vaccines.

Adjuvants, Immunologic↗
PubMedDate not supplied

An evaluation of the Nashville REACH 2010 community health screening strategy.

Community-based screening is 1 of 4 strategies selected by the Nashville REACH 2010 project for reducing disparities in heart disease and diabetes among African Americans in North Nashville, Tenn. We evaluated our screening efforts by asking 4 questions: (1) Are the screening participants representative of the target population? (2) How often were screening participants with possible undiagnosed hypertension, high cholesterol, and diabetes identified? (3) How often were screening participants with an elevated risk for developing hypertension, high cholesterol, and diabetes identified? and (4) How often did we identify screening participants with known hypertension, high cholesterol, and diabetes whose disease management was suboptimal? Results from 1757 persons screened were compared to telephone surveys from 16,199 Nashville residents. Those screened were younger and healthier than the target population. Rates of potentially undiagnosed cases among African Americans were 0.8% for diabetes, 17.4% for hypertension, and 32.7% for high cholesterol. High-risk individuals were identified 13.1% of the time for diabetes, 45.3% of the time for hypertension, and 21.3% of the time for total cholesterol. Rates of poorly controlled known disease were 23.5% for diabetes, 39.0% for hypertension, and 58.2% for total cholesterol. Although we reached a younger and healthier group than the community population, community-based screenings identified many people with potential health risks. We present a model of how to organize and implement successful community-based screening.

Adult↗
PubMedDate not supplied

Quality of abstracts of papers reporting original cost-effectiveness analyses.

BACKGROUND: Although many peer-reviewed journals have adopted standards for reporting cost-effectiveness analyses (CEAs), guidelines do not exist for the accompanying abstracts. Abstracts are the most easily accessed portion of journal articles, yet little is known about their quality. The authors examined the extent to which abstracts of published CEAs include key data elements (intervention, comparator, target population, study perspective) and assessed the effect of journal characteristics on reporting quality. METHODS: Systematic review of the English-language medical literature from 1998 through 2001. The authors searched MEDLINE for original CEAs reported in costs per quality-adjusted life years(i.e., cost-utility analyses). Two independent readers abstracted data elements and met to resolve discrepancies. RESULTS: Among the 303 abstracts reviewed, a clear description of the intervention was present in 94%, comparator in 71%, target population in 85%, and study perspective in 28%. All 4 data elements were reported in 20% of abstracts, 3 elements in 49%, 2 in 22%, and 0 or 1 in 9%. In journals with CEA-specific abstract reporting requirements, structured abstract requirements, or impact factors>or=10, significantly more data were included in abstracts than in journals without these features (P<0.01 for all comparisons). CONCLUSIONS: Abstracts of published CEAs frequently omit data elements critical to proper study interpretation. An explicit core set of reporting standards is needed, based on the standards by the US Public Health Service's Panel on Cost-Effectiveness for reporting of CEAs, but specific to the accompanying abstracts.

Cost-Benefit Analysis↗
PubMed2004

Meeting the health care needs of a rural Hispanic migrant population with diabetes.

CONTEXT: There is a need for models of health care that provide accessible, culturally appropriate, quality services to the population of Hispanic migrant farmworkers at risk for or diagnosed with diabetes. PURPOSES: The purposes of this study were to describe the Migrant Health Service, Inc (MHSI), Diabetes Program, the conceptual model on which it is based, and 4 types of outcomes achieved over a 3-year period. METHODS: Types and amounts of medical services and education were studied. Qualitative data obtained from program records and documents were analyzed to determine the nature of the program. Quantitative data were used to measure outcomes of the program. FINDINGS: The multiplecomponent MHSI Diabetes Program is addressing economic, cultural, and language barriers experienced by the target population. The program provides a continuum of health services and education that meet American Diabetes Association (ADA) Clinical Practice Recommendations on diabetes. The program exposes regional health care professionals and university students from numerous academic disciplines to Hispanic farmworker culture. CONCLUSIONS: Evidence-based program management, patient care, and program evaluation are traits of this program, which offers accessible, culturally appropriate, quality health services and education to Hispanic farmworkers. The multicomponent program model has high potential for positively impacting the health of the target population.

Diabetes Mellitus↗
PubMed1991

The potential and limitations of opportunistic screening: data from a computer simulation of a general practice screening programme.

Given the continuing emphasis on preventive medicine in general practice, there is considerable interest in the relative effectiveness of different ways of inviting patients to attend for screening. Recently, opportunistic methods have been advocated as being particularly useful but these methods often fail to reach a high proportion of the target population. Many patients do not consult and when they do they are not always invited to attend for screening. In this study a computer simulation model has been used to examine the effects of these variables in more detail. The notes of a random sample of 190 patients (97 women, 93 men) aged 30-50 years, registered with one general practitioner, were used to provide data for the model. The simulation model showed that increasing the number of screening appointments available each week has only a small effect on screening rates and that a ceiling is reached when 25 appointments per 1000 patients are available. In contrast, increasing the proportion of eligible consulting patients who are invited has a substantial effect such that it could take nearly 12 years to screen 90% of a target population if only one out of every four patients were invited compared with under four years if three out of every four patients were invited. The results suggest therefore that opportunistic screening methods are unlikely to achieve desired screening rates within acceptable time limits. It is argued that to achieve target levels of screening, practices will need to combine opportunistic methods with more formal methods of invitation.

Computer Simulation↗
PubMed2006

Relationship between the method of detection and prognostic factors for breast cancer in a community with a screening programme.

OBJECTIVES: To analyse and compare the prognostic factors of breast cancer in the target population of our community-screening programme as a function of the method of detection and to analyse the differences in the prognostic factors as a function of the patient's age and the screening episode. SETTING: A Breast Cancer-Screening Programme (BCSP) in Northeast Spain. METHODS: Observational study of all primary malignant breast lesions diagnosed in a woman between 50 and 69 years of age between 18 October 1995 and 31 December 2002. The 16 centres that women from the target population might have attended were contacted. RESULTS: A total of 225 (37.2%) of the lesions included were diagnosed through the BCSP, 59 (9.7%) interval cancers were detected, and 321 (53.1%) were detected through other circuits. Node involvement was significantly lower in the lesions detected at screening (32%) in comparison to the interval cancers (41.8%) and those detected through other circuits (47.5%). A significantly larger percentage of the interval tumours (28.6%) and the lesions diagnosed outside the BCSP (22.1%) scored >5.4 on the Nottingham Prognostic Index (NPI) than those diagnosed within the programme (10.9%). The relation between the NPI and the detection method was only statistically significant in the 65-69-year-old age group. The NPI score of the tumours detected by the BCSP showed a statistically significant association with age. CONCLUSION: This analysis has shown notable differences in some prognostic factors for breast cancer according to the method of detection. Association between age and the a priori prognosis of the malignant lesions arises.

Aged↗
PubMed1991

[An analysis of participation rates for health and cancer screenings in Wakabayashi ward of Sendai].

Persons who were non-employed as determined from the 1985 census were assumed to be the target population for health and cancer screenings, comprising 54.8% and 55.5% of both the male and female population over 40 years of age in Sendai and in Wakabayashi ward respectively. Similar mean participation rates were obtained for health screening from 1986 to 1989 of 24.0% in Sendai and 23.3% in Wakabayashi ward. However, mean participation rates differed for gastric cancer screening, being 18.2% in Sendai and 15.8% in Wakabayashi ward. Both screening rates increased from 1986 to 1989 in Sendai as well as in Wakabayashi ward. Rates for both screenings were high in the suburbs and low in metropolitan Wakabayashi ward. The target population for uterine and breast cancer screenings were 69.8% and 70.1% of women over 30 years of age in Sendai and in Wakabayashi ward respectively. Mean participation rates for uterine cancer screening from 1986 to 1989 were 33.8% in Sendai and 35.1% in Wakabayashi ward, and showed an overall decrease from 1987 to 1989 in both Sendai and Wakabayashi ward. The rate was high in the suburbs and low in metropolitan Wakabayashi ward. Mean participation rates for breast cancer screening from 1988 to 1989 were 13.9% in Sendai and 13.6% in Wakabayashi ward, with rates being low in both the suburbs as well as metropolitan. Wakabayashi ward in 1988 (the beginning year of the screening), but increasing significantly in the suburbs during the following year.

Adult↗
PubMed1978

Evaluation of the emergency department as a site for hypertension screening.

To see if the emergency department is an appropriate site for hypertension screening, the coverage, appropriateness of the target population and the adequacy of follow-up procedures were evaluated. The study was conducted in the Adult Emergency Department of The Johns Hopkins Hospital, which 61% of the community regard as their regular source of care. All patients had their blood pressure read in the emergency department. A reading of 95 diastolic or greater was used as the definition of hypertension. Data from the 1970 census and The Johns Hopkins outpatient department billing system were used to evaluate screening coverage. Data to judge the appropriateness of the target population and adequacy of follow-up were collected in a retrospective audit of a random sample of emergency department records. The overall prevalence rate of hypertensive blood pressure reading was 19.5%. Blood pressure was read in only 75% of sample cases. The potential screeining coverage ranged from 9.9% to 38.6% with an overall community coverage of 24.2%. Less than 10% of the detected hypertensives were referred for follow-up. Therefore, in some emergency departments, including the Adult Emergency Department of The Johns Hopkins Hospital, hypertension screening may be feasible.

Adolescent↗
PubMed2006

The Knee Clinical Assessment Study-CAS(K). A prospective study of knee pain and knee osteoarthritis in the general population: baseline recruitment and retention at 18 months.

BACKGROUND: Selective non-participation at baseline (due to non-response and non-consent) and loss to follow-up are important concerns for longitudinal observational research. We investigated these matters in the context of baseline recruitment and retention at 18 months of participants for a prospective observational cohort study of knee pain and knee osteoarthritis in the general population. METHODS: Participants were recruited to the Knee Clinical Assessment Study-CAS(K)--by a multi-stage process involving response to two postal questionnaires, consent to further contact and medical record review (optional), and attendance at a research clinic. Follow-up at 18-months was by postal questionnaire. The characteristics of responders/consenters were described for each stage in the recruitment process to identify patterns of selective non-participation and loss to follow-up. The external validity of findings from the clinic attenders was tested by comparing the distribution of WOMAC scores and the association between physical function and obesity with the same parameters measured directly in the target population as whole. RESULTS: 3106 adults aged 50 years and over reporting knee pain in the previous 12 months were identified from the first baseline questionnaire. Of these, 819 consented to further contact, responded to the second questionnaire, and attended the research clinics. 776 were successfully followed up at 18 months. There was evidence of selective non-participation during recruitment (aged 80 years and over, lower socioeconomic group, currently in employment, experiencing anxiety or depression, brief episode of knee pain within the previous year). This did not cause significant bias in either the distribution of WOMAC scores or the association between physical function and obesity. CONCLUSION: Despite recruiting a minority of the target population to the research clinics and some evidence of selective non-participation, this appears not to have resulted in significant bias of cross-sectional estimates. The main effect of non-participation in the current cohort is likely to be a loss of precision in stratum-specific estimates e.g. in those aged 80 years and over. The subgroup of individuals who attended the research clinics and who make up the CAS(K) cohort can be used to accurately estimate parameters in the reference population as a whole. The potential for selection bias, however, remains an important consideration in each subsequent analysis.

Aged↗
PubMed2002

Definition of sedation for symptom relief: a systematic literature review and a proposal of operational criteria.

Although sedation for symptom relief in terminally ill patients has been the focus of recent medical studies, the interpretation of research findings is difficult due to the confusing terminology. To clarify the agreements and inconsistencies in the definitions of sedation, a systematic review was performed. We searched the literature through MEDLINE from 1990 to July 2001. A total of 7 articles met the inclusion criteria. All studies included the use of sedative medications or the intention to reduce patient consciousness as an essential element of sedation. All but one study explicitly described that the primary aim of sedation was symptom palliation. Three definitions stated that target symptoms were severe, and 4 articles reported the refractory nature of the distress. On the other hand, there were marked inconsistencies in the definition of the degree of sedation, duration, pharmacological properties of medications used, target symptoms, and target populations. This review suggests that sedation includes two core factors: the presence of severe suffering refractory to standard palliative management, and the use of sedative medications with the primary aim to relieve distress. Thus, "palliative sedation therapy" can be defined as "the use of sedative medications to relieve intolerable and refractory distress by the reduction in patient consciousness." The marked inconsistencies in the definition of sedation should be considered to be subcategories of palliative sedation therapy, and we recommend that researchers define the degree of sedation, duration, pharmacological properties of medications, target symptoms, and target populations in future studies. This clarification of terminology will contribute to improving the accuracy and depth of sedation research.

Humans↗
PubMed2000

Reasonable psychometric standards for self-report outcome measures in audiological rehabilitation.

This brief review article addresses the quality of self-report rating scale outcome measures in relation to audiological rehabilitation with hearing aids. It is intended to assist those who may wish to evaluate, select, or adapt existing self-report measurement tools, or to develop new ones. The focus is not on specific scales but on the key issues in scale development and evaluation. A modern perspective is presented. Areas addressed include measurement goal definition, specification of the target population, the importance of conceptual frameworks, evaluation of reliability, validity and responsiveness, and production of norms. Reliability includes internal consistency and test-retest reliability concepts, related statistical measures such as the standard error of measurement, confidence intervals and critical differences, and some specific numerical criteria. Validity includes construct, content, face and criterion validities. Responsiveness includes some principles in the measurement of change, causes of poor responsiveness, reliability of change measures, and effect size. Concluding remarks touch on the practicality of self-report scales. It is emphasized that measurement goals and target population characteristics must be defined precisely, that existing measures should be evaluated carefully before undertaking new development, that the properties of any measure may depend strongly on its purpose and context of use, and that quantitative statistical criteria should guide the evaluation of measures as well as the design of experiments or clinical trials.

Correction of Hearing Impairment↗
PubMed1998

Management of SSRI-induced sexual dysfunction.

OBJECTIVE: To describe the occurrence and management of sexual dysfunction induced by selective serotonin-reuptake inhibitors (SSRIs), to provide an overview of sexual dysfunction, reports of SSRI-induced sexual dysfunction, and management strategies. DATA SOURCES: Information was retrieved from a MEDLINE English-literature search from January 1986 to July 1998 and by review of references. Indexing terms included sexual dysfunction, antidepressants, selective serotonergic reuptake inhibitors, fluoxetine, sertraline, paroxetine, fluvoxamine, clomipramine, buspirone, nefazodone, bupropion, cyproheptadine, amantadine, yohimbine, and central nervous system stimulants. STUDY SELECTION: There are no controlled studies describing SSRI-induced sexual dysfunction or its management. Twenty-one studies are presented, including 2 open-label studies, 12 case series, and 7 case reports. SSRI-induced sexual dysfunction is described with fluoxetine, paroxetine, sertraline, and fluvoxamine for 3-24 weeks of therapy. DATA SYNTHESIS: Data were organized according to the pharmacologic agent used in the management of SSRI dysfunction, target population, SSRI implicated, type of sexual dysfunction, experimental design, and treatment response. Data were extracted from methodology and results sections of reports. Methodologic flaws included failure to account for gender differences, omission of SSRI dose and duration, and use of concomitant drugs. CONCLUSIONS: The frequency of reports suggests that SSRI-induced dysfunction is a common adverse effect; controlled studies are necessary to determine prevalence. Most reports have occurred with fluoxetine, but this phenomenon may be related to its widespread use. Further study is needed to evaluate baseline sexual function, to define target populations, and to compare SSRIs in inducing sexual dysfunction. Serotonin antagonists and dopamine agonists have been used most often to treat SSRI-induced dysfunction and have generally been effective, but controlled studies are also needed.

Adrenergic alpha-Antagonists↗
PubMed1996

Lubeluzole in acute ischemic stroke. A double-blind, placebo-controlled phase II trial. Lubeluzole International Study Group.

BACKGROUND AND PURPOSE: We aimed to assess the safety and efficacy of lubeluzole in patients with a clinical diagnosis of acute (< 6 hours) ischemic stroke in the carotid artery territory. METHODS: A randomized, double-blind, placebo-controlled multicenter trial was conducted in 232 patients. Because treatment was administered within 6 hours and a CT scan was not mandatory before the start of treatment, 39 patients with either an intracerebral hemorrhage or ischemic stroke in the vertebrobasilar circulation were excluded from the primary efficacy analysis as prespecified in the protocol. Of the 193 patients with acute ischemic stroke in the carotid artery territory (target population), 61 received placebo, 66 lubeluzole 7.5 mg over 1 hour followed by 10 mg/d for 5 days, and 66 lubeluzole 15 mg over 1 hour followed by 20 mg/d for 5 days. RESULTS: The trial, initially aimed at a patient inclusion of 270, was terminated prematurely according to the advice of the Safety Committee because of an imbalance in mortality between the treatment groups. Mortality rates at the final follow-up of 28 days for placebo, lubeluzole 10 mg/d, and lubeluzole 20 mg/d were, respectively, 18%, 6%, and 35% in the target population, results that were confirmed in the intent-to-treat population. Multivariate logistic regression analysis showed that the lower mortality in the lubeluzole 10 mg/d group was significantly in favor of the 10 mg/d treatment (P = .019). The higher mortality rate in the 20 mg/d group could be explained, at least in part, by an imbalance at randomization that led to a higher number of patients in that group with severe ischemic stroke. A total of 26 of 66 patients (39%) who received lubeluzole 10 mg/d had a score on the Barthel Index of > 70 at day 28, indicating no or mild disability, compared with 21 of 61 (34%) in the placebo group and 19 of 66 (29%) in the lubeluzole 20 mg/d group (P = NS). CONCLUSIONS: In patients with acute ischemic stroke, the dosage regimen of 7.5 mg over 1 hour followed by 10 mg/d of intravenous lubeluzole is safe and statistically significantly reduced mortality. Further clinical trials in a larger number of patients are ongoing to confirm efficacy.

Acute Disease↗
PubMed1992

Application of a quadriceps endurance programme to patients with femur fractures immobilised by skeletal traction.

Disuse atrophy of the quadriceps muscle and knee joint stiffness at the end of a 3-month period of immobilisation in patients with a fracture of the shaft of the femur is a common problem. A new approach to it was recently researched by applying a quadriceps endurance programme to a sample of this target population. Endurance capacity of matched experimental and control groups, consisting of 11 patients each, was tested at the end of the immobilisation period. Only the experimental group received the treatment intervention. Quadriceps endurance capacity in the experimental group at the end of the test period was at a 97% level compared with normal, uninjured subjects, while the control group's performance level was 57%. The difference is highly significant (P less than 0.0001). The problem of disuse atrophy had been successfully overcome in the experimental group. The unaffected leg of 10 patients from the same target population was also tested at the end of the immobilisation period. The mean value achieved was similar to the norm, i.e. there was no significant difference when compared with normal quadriceps endurance capacity.

Exercise Therapy↗
PubMed1998

Bridgeport's Teen Outreach and Primary Services (TOPS) project: a model for raising community awareness about adolescent HIV risk.

The Greater Bridgeport Adolescent Pregnancy Program (GBAPP), based on its skills in sex education, pregnancy, and sexually transmitted disease prevention, developed the Teen Outreach and Primary Services (TOPS) project, an innovative teen-focused community outreach model to expand and ensure access to health and support services for primarily underserved minority adolescents and young adults at risk for or living with the human immunodeficiency virus (HIV). TOPS is supported by the Special Projects of National Significance Program, HIV/Acquired Immunodeficiency Syndrome (AIDS) Bureau, Health Resources and Services Administration. The target population for TOPS is inner-city minority youth (ages 15-24 years) at high risk for HIV or HIV positive. Services ranging from outreach to intensive case management were provided to 2173 youth in the project. The number of HIV-positive youth has increased from three in the first year of the project to 17 in 1997. TOPS provides outreach, case management, HIV counseling and testing, risk-reduction activities, and referrals for housing, entitlements, specialty HIV clinics, and substance abuse counseling and treatment. A group of peer educators has been recruited from among the target population and is trained and paired with the staff to provide outreach services, peer counseling, and education, and to assist with recreational opportunities.

Adolescent↗
PubMed2006

An introductory guide to survey research in anaesthesia.

Surveys allow convenient and inexpensive research. Surveys include mail-out questionnaires, email questionnaires, telephone interviews, and personal interviews. Despite a widespread perception that surveys are easy to conduct, good surveys need rigorous design, implementation and analysis. This requires substantial planning, time and effort. The most important step in designing a survey is to clearly define the question(s) the survey aims to answer The target population, measured variables and types of associations being investigated should be specific and unambiguous. Investigators should concentrate on what they 'need to know' rather than what would be 'nice to know'. During development surveys should be piloted to identify problems. The main goal when implementing a survey is to maximize the response rate to avoid misleading results. Evidence-based strategies, including brief personalized surveys with stamped return envelopes, can be used to maximize the response rate. A poorly conducted survey can lead to misleading or invalid conclusions and may undermine participation in subsequent surveys by the target population.

Anesthesiology↗
PubMed1999

[Breast cancer screening in surgical patients].

Between January and August 1996, 304 patients of the Department of General and Abdominal Surgery of the University of Mainz who were at least 40 year old, were interviewed about their breast cancer screening behavior. The aim of our investigation was to evaluate the attitude of the target population to breast screening and the value of breast palpation, completed with mammography, during the women's treatment in hospital. 168 (55%) of the interviewed women reported that they had a yearly clinical breast examination in the past. All patients underwent a clinical breast examination. 185 (60%) did not have a mammography in the past or within the past 2 years. These women were offered a mammographic examination during their treatment in the hospital. The investigation revealed one invasive breast cancer. 13 patients had abnormal mammographic or sonographic findings. Our investigation shows, that the compliance of the target population for breast cancer screening is low. Therefore it is necessary to point out the value of breast cancer prevention with clinical examination and mammography also for patients treated in the hospital for an other disease. Every female patient should undergo breast examination. But early detection of breast cancer before micrometastases have occurred is only possible by mammography.

Breast Neoplasms↗
PubMed2000

'Ilko dacowo:' canine enucleation and dental sequelae in Somali children.

OBJECTIVE: To assess the prevalence of primary canine enucleation and associated dental sequelae in Somali children resident in Sheffield. DESIGN: Cross-sectional survey. SETTING: Somali religious education classes and homework groups, selected primary and secondary schools, and the Charles Clifford Dental Hospital, Sheffield (1998-99). SUBJECTS AND METHODS: The target population were all Somali children aged between 4 and 17 years. Subjects were interviewed to obtain background sociodemographic data and an oral examination was performed. The status of the canine in each quadrant was noted, in addition to the presence of any dental anomalies in adjacent teeth. Features indicative of a history of attempted canine enucleation included: absence of primary canines, localized developmental defects affecting primary or permanent canines and lower lateral permanent incisors, and retention of lower primary lateral incisors with distal eruption of permanent lateral incisors. RESULTS: A total of 260 children were included in the study, comprising 56.5% of the target population. The mean age of the subjects was 9.7 years with an equal male and female distribution. According to the criteria devised, 82 (31.5%) of the subjects were considered to exhibit one or more of the dental features suggestive of a previous history of canine enucleation. There was no significant difference in prevalence according to gender or birthplace (UK, Somalia or another country), but a positive history was greater in subjects whose mother did not speak English. In addition to anomalies involving canines, lower permanent incisors were commonly missing (5.0% of children aged over 9 years). CONCLUSION: The suspected continuation of canine enucleation in UK-born Somali children raises important oral health issues. Culturally sensitive education is indicated to discourage this harmful ritual practice.

Adolescent↗