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The Diabetes Prevention Program: recruitment methods and results.

The Diabetes Prevention Program (DPP) is a multicenter randomized controlled trial designed to test whether diet and exercise or medication can prevent or delay the onset of type 2 diabetes in persons with impaired glucose tolerance, who are at increased risk of the disease. This paper describes DPP recruitment methods, strategies, performance, and costs. The DPP developed an organizational structure for comprehensive management and continuous monitoring of recruitment efforts. The DPP utilized a variety of recruitment strategies, alone or in combination, and a stepped informed consent procedure leading to randomization. Studywide and clinic-specific recruitment data were monitored, analyzed, and used to modify recruitment approaches. DPP recruitment was completed slightly ahead of schedule, meeting goals for the proportion of women enrolled and nearly meeting goals for the proportion of racial/ethnic minorities. Clinics varied widely in the recruitment strategies they used, and these strategies also varied by participant age, gender, and race/ethnicity. Staff time devoted to recruitment averaged 86.8 hours per week per clinic, with the majority of effort by staff specifically assigned to recruitment. The number of staff hours required to recruit a participant varied by recruitment strategy. Recruitment cost (excluding staff cost) was about 1075 US dollars per randomized participant. The DPP experience offers lessons for those planning similar efforts: (1) a method for ongoing assessment and revision of recruitment strategies is valuable; (2) a range of recruitment strategies may be useful; (3) the most effective methods for recruiting potential subjects may vary according to the gender, age, and race/ethnicity of those individuals; (4) recruitment strategies vary in the amount of staff time required to randomize a participant; and (5) a stepped screening may make it easier to identify and recruit volunteers who understand the requirements of the study.

Adult↗

Response rates to six recruitment mailing formats and two messages about a nutrition program for women 50-79 years old.

Recruiting participants for large prevention trials is time consuming and costly. In order to test various recruitment techniques, we conducted two studies of response rates to recruitment mailings for the Women's Health Trial. The potential participants, 50- to 79-year-old women, were requested to return an enclosed postcard to learn more about the trial. In the first study, we sent at random either a short or a long message to a group of University of Miami personnel (N = 862) and a Dade County cohort (N = 2964). More university women responded to the short message than to the long message (22.4% vs 16.4%, p = 0.024). Similarly, more of the Dade County cohort replied to the short message than to the long one (12.1% vs 9.6%, p = 0.027). The long message listed details of the intervention (e.g., modifying recipes) that some women may have used to decide they were not interested in participating. In the second study, we examined response rates to two different ways of addressing the mailing, i.e., handwritten envelopes and machine-printed labels; we also evaluated three methods for delivering the short message: (1) formal invitation, (2) business letter with an inside name and address of the recipient, and (3) business letter without the recipient's name and address. Response rates were similar between the methods of addressing envelopes and among the three vehicles for the message, suggesting that the least costly method of mailing should be used.

Aged↗

Mailing strategies and costs of recruiting heavy smokers in CARET, a large chemoprevention trial.

Recruitment costs represent a major portion of the budget for large clinical trials during the initial years of the study. Further, the rate of recruitment affects allocation of resources in future years. To learn about the costs and yields of recruiting from different populations and under different mailing strategies, we monitored recruitment yields of eligible heavy smokers for the Carotene and Retinol Efficacy Trial (CARET) at the Portland Study Center. Yields from the mailings, measured by response rate, percent of potential participants randomized, and related costs per randomization varied both by mailing strategy and by population targeted. Yield and cost varied significantly across population sources. Less variation was observed among various mailing strategies. Tracking the recruitment process yield provided useful information that allowed us to adjust recruitment approaches and achieve our randomization goals quickly and economically.

Aged↗

Recruitment strategies in the women's health trial: feasibility study in minority populations. WHT:FSMP Investigators Group. Women's Health Trial:Feasibility Study in Minority Populations.

The Women's Health Trial:Feasibility Study in Minority Populations (WHT:FSMP) examined the feasibility of recruiting postmenopausal women from a broad range of racial and socioeconomic backgrounds into a primary prevention trial requiring marked reductions in dietary fat. Postmenopausal women aged 50-79 yr who had no history of cardiovascular disease or cancer and who consumed 36% or more total energy from fat qualified to participate. We randomized the women into dietary intervention (60%) or control (40%) groups; we aimed to randomize 750 women in 18 months in each of the three clinical centers. All centers achieved goals for randomization based on ethnicity, and two centers exceeded overall recruitment goals. The greatest source of randomized participants was mass mailing, followed by items in the media, referrals, and community outreach. Recruitment yields were generally similar for the ethnic groups but lower for less-educated participants. The experience of WHT:FSMP indicates that postmenopausal women from the African-American, Hispanic, and non-Hispanic white communities can be recruited into dietary intervention studies for the prevention of disease.

Black or African American↗

General practitioners' attitudes toward complementary therapies.

Attitudes toward complementary therapies were elicited from a postal survey of all identified general practitioners in the state of Tasmania, Australia. Regression analysis of the data indicated that demographic features associated with favourable attitudes were younger age and location in small or single practices. Personal experiences of such therapies or patient endorsement of them were also associated with favourable attitudes. Those who saw the holistic orientation of complementary medicine as an advantage were likely to hold favourable attitudes. Those who saw the cure rate of complementary therapies as problematic and/or had personal knowledge of the harmful effects of such therapies were less likely to have favourable attitudes.

Adult↗

AIDS in the HAART era: New York's heterogeneous geography.

During the 1990s, the number of new AIDS cases in New York City, USA, declined precipitously. The declines, beginning before highly active antiretroviral therapy (HAART) was introduced, were geographically heterogeneous across two New York City boroughs analyzed. From 1993 to 1998, zip codes in Lower Manhattan, with large white and affluent populations, had declines as much as 55% more than the rest of Manhattan. Bronx zip codes underwent still lesser declines. Declines also differed within zip codes among subpopulations. White zip code populations tended to have greater declines than Latino populations, which in turn tended to have greater declines than black populations. According to bivariate and stepwise regressions, an array of socioeconomic and community stress variables acted in combination on the decline in New York AIDS. Manhattan's declines in total AIDS incidence were primarily defined by changes in AIDS incidence for whites and for men who have sex with men, racial segregation, and the proportions of households in upper income classes and under rent stress. Bronx declines in total AIDS are principally explained by a broader range of income classes, and social instability as marked by housing overcrowding and cirrhosis and drug mortalities. Whatever the combination of proximate causes for the decline in AIDS incidence in 1990s New York (educational campaigns, HAART, demographic stochasticity), the decline was shaped by the city's socioeconomic structure and political and ecological history. That structure and history generates the geographically defined aggregates of behaviors that promote or impede AIDS decline. Such spatial heterogeneity may provide for HIV refugia, areas where the virus can weather the epidemic's contraction, a troubling possibility with the accelerating microbicidal failures of combination therapies.

Acquired Immunodeficiency Syndrome↗

Communication between members of the cardiac arrest team--a postal survey.

AIMS: Effective communication enhances team building and is perceived to improve the quality of team performance. A recent publication from the Resuscitation Council (UK) has highlighted this fact and recommended that cardiac arrest team members make contact daily. We wished to identify how often members of this team communicate prior to a cardiopulmonary arrest. METHOD: A questionnaire on cardiac arrest team composition, leadership, communication and debriefing was distributed nationally to Resuscitation Training Officers (RTOs) and their responses analysed. RESULTS: One hundred and thirty (55%) RTOs replied. Physicians and anaesthetists were the most prominent members of the team. The Medical Senior House Officer is usually nominated as the team leader. Eighty-seven centres (67%) have no communication between team members prior to attending a cardiopulmonary arrest. In 33%, communication occurs but is either informal or fortuitous. The RTOs felt that communication is important to enhance team dynamics and optimise task allocation. Only 7% achieve a formal debrief following a cardiac arrest. CONCLUSION: Communication between members of the cardiac arrest team before and after a cardiac arrest is poor. Training and development of these skills may improve performance and should be prioritised. Team leadership does not necessarily reflect experience or training.

Communication↗

Measuring the population impact of knee pain and disability with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

This study has used the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in an unsolicited postal questionnaire to investigate the impact of knee pain and disability in the general older population. The study provides WOMAC population data for those aged over 50 and demographic and psychosocial associations with severity of WOMAC scores. A pilot survey (n=240) and repeatability study (n=80) were undertaken to test completion of the WOMAC in this new setting. The main questionnaire was mailed to 8,995 men and women aged over 50 registered with three general practices in North Staffordshire, UK. Completion rates for WOMAC items were high. Substantial reliability was found for pain and physical function scales (both >0.80). Fourteen percent of the over 50 population in this study had severe knee pain, 20% had severe difficulty with at least one area of physical functioning, 12% had both. The strongest link with severe difficulty with physical functioning was chronicity (odds ratio (OR)=6.49, 95% CI 4.65, 9.04). Other independent links were age over 75 years (odds ratio (OR)=4.11, 95% confidence interval (CI) 3.03, 5.58), depression (OR=2.80, 95% CI 2.22, 3.54), bilateral knee injury (OR=2.23, 95% CI 1.63, 3.06) and body mass index>30 (OR=2.00, 95% CI 1.51, 2.64). Similar associations were found for severe pain. The findings suggest that the WOMAC is a reliable measure for use in postal surveys. It has advantages over other instruments when measuring pain and physical function difficulty related to the knee. Chronicity, older age, injury, obesity and depression were all linked with higher WOMAC scores for knee pain severity and disability among knee pain sufferers in the general older population.

Activities of Daily Living↗

The Chronic Pain Grade questionnaire: validation and reliability in postal research.

The Chronic Pain Grade questionnaire has been proposed as an interview-administered, multi-dimensional measure of chronic pain severity in selected populations with chronic pain in the United States of America. It has not previously been tested in the United Kingdom, in self-completion form or in an unselected general population. We undertook a postal survey to assess its reliability, validity and acceptability in these circumstances, using a general practice population in Scotland, with a practice population of 11202 patients. A random sample of 400 patients aged over 18 was drawn, stratified for age, gender and receipt or non-receipt of regular prescriptions for pain-relieving medication. The dimensions and sub-scales of the Chronic Pain Grade were compared with the SF-36 general health questionnaire and questions relating to duration of any pain and attempts to seek treatment for this. The methodological approach proposed by Streiner and Norman (1989) was used to assess validity and reliability. A response rate of 76% was achieved. Cronbach's alpha was > 0.9 and item-total correlations were all high, indicating good internal consistency and reliability. Validity was confirmed by psychometric testing, including confirmatory factor analysis. Good correlations with comparable dimensions of the SF-36 general health questionnaire confirmed convergent validity. Construct validity was confirmed by testing scores against duration of pain and treatment sought for pain. We concluded that the Chronic Pain Grade questionnaire is a useful, reliable and valid measure of severity of chronic pain. It translates well into UK English and is acceptable in general population postal research.

Chronic Disease↗

A comparison of three "interventions" on pretreatment dropout rates in an outpatient substance abuse clinic.

Studies examining pretreatment dropout in outpatient substance abuse clinics have consistently demonstrated that fewer days between phone contact and scheduled intake appointment result in higher client show rates. To compare time to intake with two other interventions hypothesized to increase show rates, individuals (N = 128) seeking treatment were randomly assigned to one of four groups. Individuals in Group 1 were scheduled within 48 hours of the telephone intake. Individuals in Groups 2, 3, and 4 were scheduled 48 hours or more after the telephone intake and received either a reminder call 24 hours prior to their appointment (Group 2), an appointment card and clinic brochure in the mail (Group 3), or no intervention (Group 4). The results show that Group 1 had a higher show rate as compared to the other three groups, and receiving a reminder call or an appointment card did not improve show rates beyond that of the no-contact control group. Implications for intake procedures are discussed.

Adult↗

Mass mailings have little effect on utilization of influenza vaccine among Medicare beneficiaries.

BACKGROUND: We reviewed published and unpublished studies of mass mailings designed to increase utilization of influenza vaccine among Medicare beneficiaries. METHODS: Search of computerized indexes for published studies and the Medicare Peer Review Organization Health Care Quality Improvement Project database for unpublished studies. Study selection criteria were: use of a controlled trial design and use of mass mailings direct to Medicare beneficiaries to increase receipt of influenza vaccinations. Study selection and data extraction were performed in duplicate by physician reviewers with consensus resolution. RESULTS: Six controlled trials of mass mailings were identified. One study, published in the Morbidity and Mortality Weekly Report (MMWR), reported a modest but statistically significant improvement in influenza vaccination rates among patients who received a letter relative to those who did not. This study was cited as justification for mail interventions performed in five subsequent studies, none of which reported clinically meaningful results. None of these five studies was published. CONCLUSIONS: Mass mailings have at best had clinically trivial effects on increasing influenza vaccination among Medicare beneficiaries. Publication bias has contributed to continued use of a relatively ineffective intervention.

Humans↗

A mail survey of United States hematologists and oncologists: a comparison of business reply versus stamped return envelopes.

Mailed surveys are a popular means of obtaining data on large populations. In July 1999 a mail survey was conducted among 3000 randomly selected members of the American Society of Hematology to assess their approach to diagnosis and treatment of polycythemia vera. Because the researchers and the study population are members of the same professional organization with a vested interest in the results, we anticipated that the advantages of return stamped postage seen in previous studies would be less significant. The response rate for stamped return envelopes was 38% versus 32% for business reply envelopes. This statistically significant difference (P =.0005) of six percentage points is comparable to previous research. Excluding labor, the total cost per returned survey was $2.62 for business reply envelopes versus $1.82 for stamped return envelopes. We conclude that stamped return envelopes are a more effective and cost-efficient means of procuring data from physician specialists.

Compliance↗

An experiment of mailing physician surveys on two different issues in joint or separate mail.

High response rates from physicians play an important role in obtaining valid data on practice patterns. We wanted to know whether two questionnaires (one on hernia surgery and one on perioperative pain management) should better be sent out in one letter or two separate letters. We randomized 2,393 surgeons who received the two questionnaires either in one letter or by separate mail, in two letters, at a time interval of 4 weeks. The response rate for the separate mailout was not significantly higher when compared to the joint mailout. The differences were 3.3% (95%-CI -0,4% to 7.1%) and 2.2% (95%-CI -1,4% to 5.9%) for the two surveys. Due mainly to higher postage costs, the costs per response were doubled in the separate mailout group (5.85 Euro versus 2.93 Euro). Sending out two surveys separately seems to have only little effect on the response rates.

Data Collection↗

Correlates and effect of non-response in a postpartum survey of obstetrical care quality.

This study investigated the differences between unprompted respondents, prompted respondents, and non-respondents to a postpartum postal survey, and determined the likely impact of non-response on the accuracy of calculations of patient assessments of obstetrical care quality. Birth certificate and hospital discharge data were obtained for 1664 live births at three hospitals in Washington State between 8/91-10/91 and linked with 1268 completed postpartum maternal postal surveys. Non-white race, public insurance payer, unmarried status, and smoking in pregnancy were independent risk factors for non-participation. Among participants, non-white race, unmarried status, and having an infant who was low birthweight, preterm, or discharged late were independent risk factors for prompted response. The inclusion of prompted respondents did not substantially alter the calculated proportion of women rating obstetrical care quality as low, and these figures were similar to proportions estimated for the entire intended cohort using a modification of Drane's method. A one-time mailing of an obstetrical care quality survey can provide information similar to that obtained with more extensive follow-up even though substantial differences may exist between unprompted and prompted respondents, and with adjustment for factors related to non-participation and timing of response, it may be possible to obtain accurate estimation of outcome prevalences for the entire intended cohort.

Adult↗

Community-based recruitment strategies for a longitudinal interventional study: the VECAT experience.

This article examines different recruitment strategies for the VECAT Study, a 4-year, double-masked, placebo-controlled, randomized clinical trial of vitamin E in the prevention of cataract and age-related maculopathy. Five recruitment methods were employed: newspaper advertising, radio advertising, approaches to community groups, approaches via general practices, and an electoral roll mail-out. Participants (1204) from the community in Melbourne, Australia were recruited and enrolled within 15 months (age range: 55-80 years, mean 66 years; gender ratio: 57% female, 43% male). The electoral roll mail-out and newspaper advertising were the most efficient methods of recruitment in terms of absolute numbers of participants recruited and cost per participant. Recruitment for the VECAT study was successfully completed within the planned period. Although the electoral roll mail-out and newspaper advertising were the most efficient for this study, other methods may be of value for studies with different subject selection criteria.

Aged↗