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The pneumococcal vaccine. Immunization at a crossroad.

A new polyvalent pneumococcal vaccine (Pneumovax) was released in February 1978. In an effort to chronicle the dissemination of the vaccine to high-risk patients, we prospectively followed up a single clinic population and conducted a telephone survey of three neighborhood health centers, two private practices, and a university hematology clinic. Three months after notification of the vaccine arrival, physicians in the prospectively chronicled clinic had immunized six of 12 patients with sickle cell disease, five of 80 patients with chronic obstructive pulmonary disease, three of 225 patients with diabetes, and three of 45 patients older than 80 years. Immunization policy in the other clinics surveyed varied greatly. As an attempt to curb low-prevalence, high-severity illness in a small target population, the pneumococcal vaccine presents a new set of problems in the systematic implementation of an immunization.

Anemia, Sickle Cell↗

Strategies to improve recruitment to randomised trials.

BACKGROUND: Recruiting participants to randomised controlled trials (RCTs) is challenging. Identifying effective recruitment strategies would benefit health research: poor recruitment leads to underpowered trials, reducing the reliability of findings and increasing the risk of wasted resources, ethical concerns, and trial failure. Evidence to inform recruitment strategies is increasingly generated through Studies Within A Trial (SWATs), which are methodological studies embedded within host RCTs. This is an update of a review last published in 2018. OBJECTIVES: Primary: to quantify the effects of strategies to improve recruitment of participants to RCTs. Secondary: to evaluate recruitment strategies' cost-effectiveness and impact on retention, and the equity, diversity, and inclusion (EDI) characteristics of recruited participants. SEARCH METHODS: We used MEDLINE, Embase, and six other databases to identify the studies included in the review. We also sought unpublished recruitment SWATs through social media and targeted email dissemination to trial methodology networks. The latest search date was 16 February 2023. SELECTION CRITERIA: We included randomised SWATs evaluating trial recruitment strategies embedded in healthcare and non-healthcare trials. We excluded quasi-randomised, hypothetical, questionnaire-only, retention-only, or clinician incentive studies. DATA COLLECTION AND ANALYSIS: Primary outcome: proportion of eligible participants or centres recruited. SECONDARY OUTCOMES: cost-effectiveness, retention rates, and EDI characteristics of included participants. We conducted random-effects meta-analysis for strategies evaluated in at least two studies; otherwise, we synthesised results narratively. We reported effects as risk differences (RDs) with 95% confidence intervals (CIs), and assessed between-trial heterogeneity. We used GRADE to assess the certainty of evidence for the primary outcome. We expressed cost-effectiveness as the incremental cost per additional participant recruited in pounds sterling (GBP). MAIN RESULTS: We identified 91 eligible studies (53 new to this update), providing 94 comparisons and involving at least 176,747 participants. Eighty-one studies involved strategies aimed at trial participants, while 10 evaluated strategies aimed at recruiters. All were healthcare studies. We found 65 recruitment strategies; 49 were evaluated in a single study. Only five strategies were supported by high-certainty evidence according to GRADE criteria, and we focus on these strategies in the summary below. Open-label trials versus blinded, placebo trials. Open-label trials recruited more participants than blinded trials (RD 10%, 95% CI 8% to 12%; 3 studies, 9004 participants), corresponding to approximately 10 additional participants per 100 approached. The studies involved mostly women in the UK and Estonia. No cost or retention data were reported. Telephone reminder versus no telephone reminder. Telephone reminders to people who did not respond to an initial postal invitation boosted recruitment by 6% (95% CI 3% to 9%; 2 studies, 1450 participants), in trials with low underlying recruitment (we are less certain for trials with over 10% recruitment). The studies involved people with a mean age of 58 years in Canada and Norway. No cost or retention data were reported. Recruitment primer letter versus no letter. Pre-recruitment letters and leaflets designed to encourage participation made little or no difference to recruitment (absolute improvement 1%, 95% CI -1% to 2%; 2 studies, 5376 participants), and were associated with increased costs compared to not sending a primer (incremental cost: GBP 2.08). The studies involved mostly older white people in the UK and Ireland. Multimedia information via a digital link/QR code plus paper participant information leaflet (PIL) versus paper PIL alone. This made little or no difference to recruitment (absolute improvement 0%, 95% CI -1% to 1%; 7 studies, 11,612 participants) and retention (absolute improvement 0%, 95% CI -2% to 3%; 5 studies, 7403 participants), and increased costs compared to not including multimedia information (incremental cost: GBP 0.78). The studies involved people in the UK. Optimised, user-tested PIL versus standard PIL. Optimising participant information leaflets (e.g. through user-testing the leaflet with the target population to shape its content, format, and appearance) made little or no difference to recruitment: absolute improvement was 0% (95% CI 0% to 1%; 6 studies, 27,805 participants). The studies involved people in the UK. Only one study reported EDI data; participants were mostly older women. No cost or retention data were reported. We had moderate-certainty evidence for 13 other strategies; confidence was often reduced because the results came from single studies. Seven strategies involved changes to how potential participants received information; four involved changes to trial conduct; one targeted the recruiter or recruitment site; and one tested non-monetary incentives. We had much less confidence in the other 47 comparisons because the studies had design flaws, were single studies, or had very uncertain results. Costs were reported in only 17 of 91 studies. Strategy impact on retention was reported in 15 studies. All but one study (99%) were from high-income countries. The most reported demographics were age (49 studies), sex (32 studies), gender (27 studies), and education level (16 studies). AUTHORS' CONCLUSIONS: The evidence on strategies to improve trial recruitment remains broad but lacks depth. Of 65 strategies evaluated, only five were supported by high-certainty evidence. Open-label trial designs and telephone reminders to non-responders increased recruitment, while optimised participant information leaflets, recruitment primer letters, and multimedia information provided alongside a paper participant information leaflet had little or no effect. Reporting of participant characteristics was poor, limiting assessment of equity, diversity, and inclusion across most studies. Evidence is heavily skewed toward high-income countries. Future research must prioritise evaluations in low-to-middle-income settings and consistently report cost, retention, and EDI outcomes. We strongly urge the methodology research community to strengthen the evidence base by prioritising replications of existing strategies over the development and testing of new ones. FUNDING: National Institute for Health and Care Research (Advanced Fellowship, Adwoa Parker, reference:NIHR302256). Health Research Board, Republic of Ireland, Evidence Synthesis Ireland (grant ESI-2021-001) REGISTRATION: This review updates an earlier Cochrane review, which was first published in 2002 and subsequently updated in 2007, 2010, and 2018. Previous versions of the review and their protocols are available at: https://doi.org/10.1002/14651858.MR000013.pub2 https://doi.org/10.1002/14651858.MR000013.pub3 https://doi.org/10.1002/14651858.MR000013.pub4 https://doi.org/10.1002/14651858.MR000013.pub5 https://doi.org/10.1002/14651858.MR000013.pub6.

Randomized Controlled Trials as Topic↗

Application of a latent variable model for a multicenter study on early effects due to mercury exposure.

A latent variable model was applied to the results of an Italian multicenter nation-wide cross-sectional study to assess the earliest health effects due to mercury (Hg) exposure caused by occupation, dental amalgams (DENTAM) and fish eating (FISH). The studied population included subjects recruited from four different geographical areas. A total number of 122 workers from chloroalkali plants and production of thermometers and neon lamps formed the occupationally exposed group, whereas 196 subjects, recruited from the same areas and not occupationally exposed to mercury, formed the control group. Neuropsychological functions were assessed with neurobehavioral testing including vigilance, motor and cognitive function, tremor measurements, and with symptoms concerning neuropsychological and mood assessment. Neuroendocrine function was examined with the measurement of prolactin (PRL) level. Parameters of immunological and renal function were also measured. The target population was characterized by the number and surface of dental amalgams and consumption of fish. In the exposed workers the average urinary mercury (U-Hg) was 10.4+/-6.9 (geometric mean 8.3, range 0.2-35.2) microg/g creatinine, whereas in the control group it was 1.9+/-2.8 (geometric mean 1.2, range 0.1-33.2) microg/g creatinine. The preliminary results indicated that finger tapping (FT) and the Branches alternate movement task (BAMT) coordination test were associated with the occupational exposure (OCCEXP). PRL was significantly decreased among the exposed workers, and inversely related to U-Hg. Among the immunological and renal parameters, cytokine serum interleuchin-8 (sIL8) and beta(2) micro globulin (beta(2)MG) were lower in the exposed group and negatively correlated to U-Hg. Small-size fish consumption was associated to a beneficial effect on symptoms reporting. No effects were observed concerning dental amalgams. After first evaluating the relationship between mercury exposure and each indicator of effect, further assessment was performed to identify the earliest effects related to mercury exposure among those who resulted in being associated in the preliminary elaboration. Two latent variables "exposure" and "effect" were identified, integrating respectively the different forms of exposure (occupational, due to dental amalgams and fish consumption) and the indicators of effects (FT, BAMT, PRL, sIL8, beta(2)MG). Confounding factors (age, alcohol, body mass index (BMI)) were considered in the same model. This further analysis showed that an inverse association of occupational exposure to mercury with PRL and BAMT, with Hg-U mediating the effect on PRL, was predominant with respect to the other form of mercury exposure, the other indicators of effect and the confounders. In conclusion, this study supports the finding of alterations of neuroendocrine secretion and motor coordination at very low occupational exposure levels of inorganic mercury, below the current ACGIH Biological Exposure Index. These changes occur at lower levels than other subtle effects on the renal function and the immunitary system. On the contrary, dental amalgams and small-size fish consumption do not seem to be associated to any adverse health effect at these exposure levels.

Adult↗

Is an expanded nurse role economically viable?

RATIONALE: Community health practitioners (CHPs) in Korea are Registered Nurses with a 6-month special training who have responsibility for delivering primary health care to remote or isolated communities. Research has indicated that these practitioners' contribution to improving the health of rural and remote populations has been effective. Despite this, CHP programmes have been fundamentally re-examined by the Korean government, as a consequence of the national economic crisis of 1998 and restructuring of the health care delivery system. AIM: The aim of this paper is to analyse CHP services in primary health care, and evaluate some of the economic impacts of these services through a cost-minimization analysis. METHODS: A retrospective, descriptive-correlational design was used. A self-administered questionnaire was sent to 600 CHPs who were randomly selected from the target population, and 272 returned the questionnaire after one reminder letter, a response rate of 45.3%. RESULTS: There was a significant difference in average cost of care between a model based on CHP services and one including no CHP services, in which equivalent care was provided by physicians (t = -6.833, P < 0.001). The average costs ratio was 2.16 (sd = 1.24), with a range of 0.09-9.63, indicating that CHP services were almost half the price of the 'no CHP services' model. CONCLUSIONS: The results provide evidence of the economic validity of the CHP's role in the public sector, where there is no net income to serve as a policy guideline. The conclusion can be drawn that CHP services are more effective than physician services (or 'no CHP services').

Community Health Nursing↗

The Oslo Health Study: The impact of self-selection in a large, population-based survey.

BACKGROUND: Research on health equity which mainly utilises population-based surveys, may be hampered by serious selection bias due to a considerable number of invitees declining to participate. Sufficient information from all the non-responders is rarely available to quantify this bias. Predictors of attendance, magnitude and direction of non-response bias in prevalence estimates and association measures, are investigated based on information from all 40 888 invitees to the Oslo Health Study. METHODS: The analyses were based on linkage between public registers in Statistics Norway and the Oslo Health Study, a population-based survey conducted in 2000/2001 inviting all citizens aged 30, 40, 45, 59-60 and 75-76 years. Attendance was 46%. Weighted analyses, logistic regression and sensitivity analyses are performed to evaluate possible selection bias. RESULTS: The response rate was positively associated with age, educational attendance, total income, female gender, married, born in a Western county, living in the outer city residential regions and not receiving disability benefit. However, self-rated health, smoking, BMI and mental health (HCSL) in the attendees differed only slightly from estimated prevalence values in the target population when weighted by the inverse of the probability of attendance.Observed values differed only moderately provided that the non-attending individuals differed from those attending by no more than 50%. Even though persons receiving disability benefit had lower attendance, the associations between disability and education, residential region and marital status were found to be unbiased. The association between country of birth and disability benefit was somewhat more evident among attendees. CONCLUSIONS: Self-selection according to sociodemographic variables had little impact on prevalence estimates. As indicated by disability benefit, unhealthy persons attended to a lesser degree than healthy individuals, but social inequality in health by different sociodemographic variables seemed unbiased. If anything we would expect an overestimation of the odds ratio of chronic disease among persons born in non-western countries.

Journal Article↗

Do training programs help AFDC recipients leave the welfare rolls? An evaluation of New York City's BEGIN (Begin Employment Gain Independence Now) program.

Guided by the Federal Family Support Act of 1988 and the Job Opportunity and Basic Skills Program (JOBS), welfare reform initiatives on state and local levels were designed to foster employability among the public assistance population. Reform has focused on enhancing the supply of labor rather than the demand for labor as a route to labor force participation for the public assistance population. Program reforms assume that, by providing job training, educational services, and training-related expenses, labor market entry of the participating clientele would be facilitated while caseloads and public expenditures would decline. To date, analysis of similar programs in many states indicates that the impact of such programs in reducing public assistance caseloads is marginal. In New York City, despite the large investment of public funds in such programs, prior to this study the outcome of program implementation remained largely unknown. This study evaluates New York City's BEGIN program outcome target defined as the ability of the program to move welfare clients off public assistance and into the labor market. While the results of the study indicate that New York City's BEGIN program does not improve client's odds of leaving welfare, when compared to the odds of a non-participation client, there are several significant findings. The impact of program participation can be distinguished among distinct age groups. While older clients responded positively to BEGIN participation, access to day care was the only factor that significantly improved the probability that clients younger than 36 years of age would leave the welfare rolls within a two-year period. In response to the findings, the researchers suggest that future welfare reform efforts should grant localities broader flexibility to determine their own target population so that resources can be allocated to those groups that are most likely to benefit from specific programs.

Adolescent↗

The costs of registry-based immunization interventions.

BACKGROUND: Part of the payoff of immunization registries may be to lower costs of immunization intervention. However, registry-based intervention costs have not been evaluated in a community setting. METHODS: The purpose of this study was to prospectively measure the cost of three equally effective registry-based interventions, evaluate how the size of the targeted population affects cost estimates, and compare these results with previously reported studies. A total of 3050 children aged <12 months were randomized to one of four study arms: (1) computer-generated telephone messages (autodialer), (2) outreach worker, (3) autodialer with outreach worker backup, or (4) usual care. The cost data collected included capital equipment, supplies, travel, and personnel. RESULTS: Monthly costs of the three registry-based intervention types were (1) autodialer, $1.34 per child; (2) outreach worker, $1.87 per child, and (3) combination, $2.76 per child. Personnel costs represented the majority of incremental costs for all three interventions. Increasing the number of children targeted sharply decreased the cost per child for the autodialer but had only a modest effect on outreach costs. The monthly costs for outreach were substantially lower than previously reported for nonregistry-based interventions in part because of differences in the number of children who were followed up. Monthly costs for the autodialer intervention were slightly higher than previously reported, but several published studies excluded important costs. CONCLUSIONS: By facilitating the management of a larger cohort of children, some registry-based immunization interventions appear to be less costly than nonregistry interventions. Further work is needed to establish whether registry maintenance costs may be recouped in part by these savings.

Costs and Cost Analysis↗

Canadian Aboriginal communities: a framework for injury surveillance.

At the international level, evidence supports the position that regardless of whether a country is industrialized or less developed, vulnerable populations living in poor social conditions are at disproportionate risk of injury. The Aboriginal population of Canada is one such vulnerable population. In addition to poor social conditions and marginalization related to historical injustices, this population is faced with the challenge of working with little or no descriptive injury data relevant to the community level. It has been and continues to be a significant barrier to the adoption and implementation of injury prevention strategies and programs. Recognizing that surveillance is an intrinsic component of public health practice, this study was undertaken to address a critical data gap facing Aboriginal communities. The objective of the study was to develop the conceptual design of an injury surveillance framework that would be culturally relevant, that is 'acceptable and owned by the target population', and would meet the specific requirements for injury data and data collection methods for the study population. The methodology was undertaken with focus groups at national and community levels, and relied on the use of strategic activities such as benchmarking, guided discussions, nominal group technique exercises and critical document reviews. The process of benchmarking served to identify that injury surveillance systems described in the literature, linking data to action, are not a predominant reality. The locus of control is often removed from the population of interest and resides primarily with experts under the jurisdiction and control of designated authorities. In order for the surveillance system to have cultural relevance, the focus group identified that the locus of control must be defined by the population of interest at the community level, and that the system must be germane and flexible to consider the local environment. The Aboriginal framework proposed places the locus of control with the community, in partnership with its data sources. Surveillance activities remain largely distinct from communities of interest, leading us to consider whether structural changes can serve to promote a link between data and action. Traditional or standard surveillance systems, by virtue of their structure, promote a disassociation between information and community action. Data management under the complete jurisdiction of sources external to a community appears to obstruct potential linkages between information and action.

Benchmarking↗

Pest control by genetic manipulation of sex ratio.

We model the release of insects carrying an allele at multiple loci that shifts sex ratios in favor of males. We model two approaches to sex ratio alteration. In the first (denoted SD), meiotic segregation (or sperm fertility) is distorted in favor of gametes carrying the male-determining genetic element (e.g., Y-chromosome). It is assumed that any male carrying at least one copy of the SD allele produces only genotypically male offspring. In the second approach (denoted PM), the inserted allele alters sex ratio by causing genetically female individuals to become phenotypically male. It is assumed that any insect carrying at least one copy of the PM allele is phenotypically male. Both approaches reduce future population growth by reducing the number of phenotypic females. The models allow variation in the number of loci used in the release, the size of the release, and the negative fitness effect caused by insertion of each sex ratio altering allele. We show that such releases may be at least 2 orders of magnitude more effective than sterile male releases (SIT) in terms of numbers of surviving insects. For example, a single SD release with two released insects for every wild insect and a 5% fitness cost per inserted allele could reduce the target population to 1/1000th of the no-release population size, whereas a similar-sized SIT release would only reduce the population to one-fifth of its original size. We also compare these two sex ratio alteration approaches to a female-killing (FK) system and the sterile male technique when there are repeated releases over a number of generations. In these comparisons, the SD approach is the most efficient with equivalent pest suppression achieved by release of approximately 1 SD, 1.5-20 PM, 2-70 FK, and 16-3,000 SIT insects, depending on conditions. We also calculate the optimal number of SD and PM allele insertions to be used under various conditions, assuming that there is an additional genetic load incurred for each allelic insertion.

Alleles↗

Messaging Strategies for Tobacco Prevention and Cessation Among People with Depression: A Scoping Review.

INTRODUCTION: Depression is strongly associated with higher tobacco use and lower quit rate; few communication campaigns have been designed with these mental health factors in mind. This scoping review compiles existing research on tobacco prevention and cessation messaging involving people with depression to identify gaps and opportunities for future message development. METHODS: Sources included PubMed, PsycINFO, Scopus, Academic Search Premier, and ProQuest Central (November - December 2024). The 55 studies included examined tobacco prevention or cessation messages and measured depression, depressive symptoms, or mental health as a primary outcome or analytic covariate. Study characteristics, target population, delivery format, message content, theoretical frameworks, outcomes, and gaps were extracted. RESULTS: RCTs made up half (51%) of the included studies, and most (78%) were conducted in the U.S. Nearly half (46%) required participants to have a mental health condition. Interventions most often used interactive (65.5%) or text-based (47.3%) communication and focused on tobacco cessation (89%) rather than vaping (9%). Common outcomes included feasibility or acceptability (37.7%) and point prevalence abstinence (37.7%). Mental health-specific messages showed mixed effectiveness. CONCLUSIONS: Despite progress in integrating mental health into tobacco messaging, targeted interventions for people with depression remain limited. Few studies tested long-term outcomes or used biochemical verification; many relied on untargeted generalized messaging.

Journal Article↗

[Potential coverage and real coverage of ambulatory health care services in the state of Mexico. The case of 3 marginal communities in Atenco and Chalco].

Less than a third of the non-insured population studied through a sample in the State of Mexico was covered by the Institute of Health of the State of México. This low coverage was observed in spite the fact that health services were available within 2 kilometer radius. 33 per cent of the non-insured preferred to utilize other services within their own community, and 24 per cent of them traveled to bigger localities to receive care. These results suggest that to attain adequate coverage, utilization patterns should be investigated so that health services can meet the needs of the target population.

Ambulatory Care↗

[Development of products for the elderly population: vitamin enriched pudding].

An instant dessert powder, pudding type was developed to be consumed at lunch or dinner time. The dessert was designed to be prepared in skim milk and meets the nutritional needs of elderly people. The dessert contains modified starch, carragenine, vegetal fat, sacharose. Each serving has been enriched with 30% of the daily vitamin requirement advised for adults over 51 years old. The optimized process was carried out according to the Karlsruhe test. Each serving consists of 22g powder prepared in proportion of 18% in skim milk. The optimized dessert powder was controlled by means of physical, chemical and microbiological analyses. The sensory quality was determined in the ready to eat product and the acceptability level was measured in a group of people selected according to the characteristics of the target population. The dessert powder contains 1.1% protein, 5.2% fats, 89.76% carbohidrates, and provides 409 Kcal/100g. Both the sensory and microbiological quality were good and the level of acceptance reached 98%.

Aged↗

A Bayesian approach to analysing the cost-effectiveness of two primary care interventions aimed at improving attendance for breast screening.

AIMS: To assess the cost-effectiveness of two primary care interventions, a letter and a flag, aimed at improving attendance for breast screening among (i) all women invited for breast screening and (ii) non-attenders. METHODS: A probabilistic decision analytic model was developed using Markov chain Monte Carlo simulation implemented in WinBUGS. The model was populated using economic and effectiveness data collected alongside two randomised controlled trials. RESULTS: For all women invited, the incremental cost-effectiveness ratio (ICER) for the letter compared with no intervention is 27 pounds per additional attendance, and the ICER for the combined letter and flag intervention compared to the letter alone is 171 pounds. The corresponding ICERs for non-attenders are 41 pounds and 90 pounds. The flag intervention is an inefficient option in both settings. A large proportion of the costs fall on the practices (25-67%), depending on the intervention and target population. The total costs incurred do not, however, seem prohibitive. Expected value of perfect information suggests that there is greater value in carrying out further research on the intervention implemented among all women invited for breast screening rather than on non-attenders. CONCLUSIONS: The flag intervention alone does not appear to be an efficient option. The choice between the letter and both interventions combined is subjective, depending on the willingness to pay for an additional screening attendance.

Bayes Theorem↗

[Causes and psychosocial consequences of schizophrenia: the opinions of patient's relatives].

OBJECTIVE: Description of the opinions on schizophrenia and its psychosocial consequences in a sample of relatives of patients with schizophrenia, recruited in 30 Italian Mental Health Centres (MHC), stratified by geographic areas and population density. DESIGN: Cross-sectional study on key-relatives of clinically stable patients with a DSM-IV diagnosis of schizophrenia. Evaluation of relatives' opinions on schizophrenia and its psychosocial consequences, in relation to: a) patient's clinical and family's socio-demographic variables; b) geographic areas and population density. SETTING: 30 Italian MHC randomised and stratified by geographic areas (Northern, Central, Southern Italy) and population density (> 100,000 inhabitants; between 100,000 and 25,000 inhabitants; < 25,000 inhabitants). Main outcome measures--Patient's clinical status and social functioning: Brief Psychiatric Rating Scale (BPRS) and Disability Assessment interview (AD). Interventions provided to patient and his/her family: Scheda di Rilevazione degli Interventi--Pattern of Care Schedule (SRI). Relatives' opinions on schizophrenia and its psychosocial consequences: Questionnaire on the Opinions of the Family (QOF). RESULTS: Data on 709 patients and their key-relatives were collected. Relatives' pessimistic opinions on social competence of patients with schizophrenia were found to be associated with: high levels of patient's disability, hostility and negative symptoms, relatives' knowledge of patient's diagnosis of schizophrenia, residence in a medium or low population density area, low levels of relative's education. Relatives' pessimistic opinions on social restrictions imposed by schizophrenia were found to be associated with high levels of disability and high number of hospital admissions in the patient and older age in the relative. CONCLUSIONS: The results of this study emphasise the need to: a) provide families with educational interventions covering not only clinical aspects of schizophrenia, but also those concerning disability and psychosocial consequences of the disorder; b) plan educational campaigns on mental illnesses which take into account the socio-cultural characteristics of the target populations.

Adolescent↗

The development and evaluation of lighten up, an Australian community-based weight management program.

UNLABELLED: Programs of widely ranging size were conducted successfully in seven localities and thus the program was considered an operational success. The reductions in weight, blood pressure, and waist and hip measurements observed at the 3-month follow-up compared well with reports of other community-based programs. Almost all participants evaluated the program highly and reported positive changes in behaviors related to food and exercise. Qualitative data indicate that the coordinators developed a sense of ownership of the program--which will be vital to its sustainability. Rapport between coordinators and participants was more easily established in smaller programs than in larger ones and was an important underlying determinant of retention rates. SIGNIFICANCE: The Lighten Up program integrates environmental and individual strategies to facilitate changes towards a positive, lifestyle approach to long-term weight management. The program aims to establish sustainable social support networks with effective links to health services. This study has demonstrated that, with appropriate training and resources, existing public sector, primary health care personnel with no previous experience in health promotion can implement the program successfully in several communities concurrently. In the Australian context, this program can play an important role as one strategy in a range of interventions required to address the issue of obesity. The stepped-care model described by Brownell proposes that program options of varying intensity, and thus cost, be available to meet the variety of needs of overweight people who wish to lose weight. The Lighten Up program was close to the midpoint of that range in that it combined population strategies with one-on-one contact with health care personnel. LIMITATIONS: Participants in the study were self-selected people who had acted quickly to enroll in the program, and it is therefore likely that the sample was overrepresented with early adopters who may have been more successful than others would have been. We cannot tell from this developmental study whether or not the program will appeal to population groups known to be at high risk for obesity. This is an important question that needs to be addressed in future research. No control group was included in the design and thus we cannot be sure the benefits experienced by the participants resulted from the program. However, process evaluation data indicate that nothing that might explain the findings, other than the program, occurred in the communities during the time of the study. Further important issues to be evaluated include: the long-term maintenance of weight loss; whether or not the program will reach targeted populations, particularly groups of low socioeconomic status; and the extent to which the public health staff will maintain enthusiasm for the training and the programs.

Adult↗

Cost-effectiveness of colonoscopy in screening for colorectal cancer.

BACKGROUND: Fecal occult blood testing, flexible sigmoidoscopy, and colonoscopy are used to screen patients for colorectal cancer. OBJECTIVE: To compare the cost-effectiveness of fecal occult blood testing, flexible sigmoidoscopy, and colonoscopy. DESIGN: The cost-effectiveness of the three screening strategies was compared by using computer models of a Markov process. In the model, a hypothetical population of 100 000 persons 50 years of age undergoes annual fecal occult blood testing, sigmoidoscopy every 5 years, or colonoscopy every 10 years. Positive results on fecal occult blood testing or adenomatous polyps found during sigmoidoscopy are worked up by using colonoscopy. After polypectomy, colonoscopy is repeated every 3 years until no polyps are found. DATA SOURCES: Transition rates were estimated from U.S. vital statistics and cancer statistics and from published data on the sensitivity, specificity, and efficacy of various screening techniques. Costs of screening and cancer care were estimated from Medicare reimbursement data. TARGET POPULATION: Persons 50 years of age in the general population. TIME HORIZON: The study population was followed annually until death. PERSPECTIVE: Third-party payer. OUTCOME MEASURE: Incremental cost-effectiveness ratio. RESULTS OF BASE-CASE ANALYSIS: Compared with colonoscopy, annual screening with fecal occult blood testing costs less but saves fewer life-years. A screening strategy based on flexible sigmoidoscopy every 5 or 10 years is less cost-effective than the other two screening methods. RESULTS OF SENSITIVITY ANALYSIS: Screening with fecal occult blood testing is more sensitive to changes in compliance rates, and it becomes easily dominated by colonoscopy under most conditions assuming less than perfect compliance. Other assumptions about the sensitivity and specificity of fecal occult blood testing, screening frequency, efficacy of colonoscopy in preventing cancer, and polyp incidence have a lesser influence on the differences in cost-effectiveness between colonoscopy and fecal occult blood testing. CONCLUSIONS: Colonoscopy represents a cost-effective means of screening for colorectal cancer because it reduces mortality at relatively low incremental costs. Low compliance rates render colonoscopy every 10 years the most cost-effective primary screening strategy for colorectal cancer.

Colonoscopy↗

Geographic disparities in cervical cancer mortality: what are the roles of risk factor prevalence, screening, and use of recommended treatment?

CONTEXT: Despite advances in early detection and prevention of cervical cancer, women living in rural areas, and particularly in Appalachia, the rural South, the Texas/Mexico border, and the central valley of California, have had consistently higher rates of cervical cancer mortality than their counterparts in other areas during the past several decades. METHODS: This paper reviews the published literature from 1966 to July 2002 to assess three potential pathways underlying this excess mortality--high human papilloma virus (HPV) prevalence, lack of or infrequent screening and advanced disease at diagnosis, and under-use of recommended treatment and shorter survival. FINDINGS: Living in rural areas may impose barriers to cervical cancer control, including lack of transportation and medical care infrastructures. Population characteristics that place women at greater risk for developing and dying from cervical cancer, such as low income, lack of health insurance, and physician availability, are concentrated in rural areas. Published data, however, are insufficient to identify the key reasons for the observed mortality patterns. CONCLUSIONS: At this time, given the lack of definitive evidence in the published literature, decisions about priorities in areas with high rates of cervical cancer mortality will depend on knowledge of current levels of screening, incidence, and stage distribution; and service delivery infrastructures, resources, and acceptability of interventions to the target population.

Female↗

Exploring the effect of transient exposure on the risk of acute events by means of time-window designs: an application to fluoroquinolone antibacterials and arrhythmia.

PURPOSE: To compare different strategies in allocating time-window at risk and in choosing optimal comparator in the setting of proarrhythmic effects of antibacterial fluoroquinolones. DESIGN: A population-based cohort study. SETTING: Resident population of a Northern Italian Province. PARTICIPANTS: The study cohort comprised 75 226 patients who received at least one prescription for fluoroquinolone from 1997 to 1999. Cohort members who experienced at least an antiarrhythmic drug prescription and/or hospitalisation with diagnosis of arrhythmia during the follow-up were identified. ANALYSIS: Trends in incidence rates of arrhythmia according to different strategies in allocating time-windows at risk were calculated. Standardised incidence ratios were obtained by comparing arrhythmic events experienced by the study cohort during the time-windows at risk with those expected from both external (unexposed target population) and internal (study cohort during reference time-windows) comparators. RESULTS: The rate of arrhythmia was 21.0 per 100 000 person-weeks during the in-treatment period, remained stable during the following week, and progressively decreased until to converge to 7.7 per 100 000 person-weeks from 16th weeks after stop of exposure. Standardised incidence ratios were 2.35 (95%CI: 1.82, 2.99) and 1.86 (1.44, 2.37) according to external and internal comparators respectively. Evidence of linear increasing of proarrhythmic effect with the length of the antibacterial therapy appeared from every approaches, but it was stronger by using internal comparator. CONCLUSIONS: Time-windows designs should be performed by allocating the time-windows at risk and comparing outcome events observed in the cohort during these periods with those experienced by the same cohort during an adequate reference period.

Anti-Bacterial Agents↗