Contraceptive sterilization use among married men in the United States: results from the male sample of the National Survey of Family Growth

Background

Surgical sterilization has many advantages. Previous information on prevalence and correlates was based on surveys of women.

Study Design

We estimated the prevalence of vasectomy and tubal ligation of partners for male participants in the 2002 National Survey of Family Growth, a nationally representative survey of US residents aged 15-44 years. We identified factors associated with sterilizations using bivariate and multivariate techniques.

Results

The findings revealed that 13.3% of married men reported having had a vasectomy and 13.8% reported tubal sterilization in their partners. Vasectomy increased with older age and greater number of biological children, non-Hispanic white ethnicity, having ever gone to a family planning clinic. Tubal sterilization use was more likely among men who had not attended college, those of older age and those with live births.

Discussion

One in eight married men reported having vasectomies. Men who rely on vasectomies have a somewhat different profile than those whose partners have had tubal sterilizations.     

Understanding of informed consent in a low-income setting: three case studies from the Kenyan Coast

In our research unit on the Kenyan Coast, parents sign consent for over 4000 children to be involved in research activities every year. Children are recruited into studies ranging from purely observational research to the testing of new procedures and drugs. Thousands more community members consent verbally or in writing to the interviews and sometimes invasive procedures required in community-based research. Although every study and consent form is reviewed in advance by independent national and international committees, the views and understanding of the 'subjects' of these activities had not been documented before this study. In this paper, we focus on participant understanding of one field-based and two hospital-based studies, all of which involve blood sampling. The findings highlight a range of inter-related issues for consideration in the study setting and beyond, including conceptual and linguistic barriers to communicating effectively about research, the critical and complex role of communicators (fieldworkers and nurses) in consent procedures, features of research unit-community relations which impact on these processes, and the special sensitivity of certain issues such as blood sampling. These themes and emerging recommendations are expected to be relevant to, and would benefit from, experiences and insights of researchers working elsewhere.     

Taking social relationships seriously: lessons learned from the informed consent practices of a vaccine trial on the Kenyan Coast

Individual informed consent is a key ethical obligation for clinical studies, but empirical studies show that key requirements are often not met. Common recommendations to strengthen consent in low income settings include seeking permission from community members through existing structures before approaching individuals, considering informed consent as a process rather than a single event, and assessing participant understanding using questionnaires. In this paper, we report on a qualitative study exploring community understanding and perceptions of a malaria vaccine trial (MVT) conducted in a rural setting on the Kenyan Coast. The MVT incorporated all of the above recommendations into its information-giving processes. The findings support the importance of community level information-giving and of giving information on several different occasions before seeking final individual consent. However, an emerging issue was that inter-personal interactions and relationships between researchers and community members, and within the community, play a critical role in participants' perceptions of a study, their decisions to consent or withdraw, and their advice to researchers on study practicalities and information to feedback at the end of the trial. These relationships are based on and continually tested by information-giving processes, and by context specific concerns and interests that can be difficult to predict and are well beyond the timescale and reach of single research activities. On the basis of these findings, we suggest that the current move towards increasingly ambitious and stringent formal standards for information-giving to individuals be counter-balanced with greater attention to the diverse social relationships that are essential to the successful application of these procedures. This may be assisted by emphasising respecting communities as well as persons, and by recognising that current guidelines and regulations may be an inadequate response to the complex, often unpredictable and ever shifting ethical dilemmas facing research teams working 'in the field'.     

The long-term impacts of Medicaid exposure in early childhood: Evidence from the program's origin

This paper examines the long-term impact of exposure to Medicaid in early childhood on adult health and economic status. The staggered timing of Medicaid's adoption across the states created meaningful variation in cumulative exposure to Medicaid for birth cohorts that are now in adulthood. Analyses of the Panel Study of Income Dynamics suggest exposure to Medicaid in early childhood (age 0–5) is associated with statistically significant and meaningful improvements in adult health (age 25–54), and this effect is only seen in subgroups targeted by the program. Results for economic outcomes are imprecise and we are unable to come to definitive conclusions. Using separate data we find evidence of two mechanisms that could plausibly link Medicaid's introduction to long-term outcomes: contemporaneous increases in health services utilization for children and reductions in family medical debt.     

Increased 1-year continuation of DMPA among women randomized to self-administration: results from a randomized controlled trial at Planned Parenthood

Objectives

Self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA-sc) is feasible, acceptable, and effective. Our objective was to compare one-year continuation of DMPA-sc between women randomized to self-administration versus clinic administration.

Dieting and the development of eating disorders in obese women: results of a randomized controlled trial

BACKGROUND: Some investigators fear that dieting may precipitate binge eating and other adverse behavioral consequences. OBJECTIVE: The objective of the study was to examine whether dieting would elicit binge eating and mood disturbance in individuals free of these complications before treatment. DESIGN: A total of 123 obese women were randomly assigned to 1) a 1000 kcal/d diet that included 4 servings/d of a liquid meal replacement (MR); 2) a 1200-1500 kcal/d balanced deficit diet (BDD) of conventional foods; or 3) a nondieting (ND) approach that discouraged energy restriction. All women attended weekly group sessions for 20 wk and biweekly sessions from week 20 to week 40. RESULTS: At week 20, participants in the MR, BDD, and ND groups lost 12.1 +/- 6.7%, 7.8 +/- 6.0%, and 0.1 +/- 2.4% of initial weight, respectively (P < 0.001). During the first 20 wk, there were no significant differences among groups in the number of persons who had objective binge episodes or in reports of hunger or dietary disinhibition. Symptoms of depression decreased significantly more (P < 0.001) in the MR and BDD groups than in ND participants. At week 28, significantly more (P < 0.003) cases of binge eating were observed in MR participants than in the 2 other groups. No differences, however, were observed between groups at weeks 40 or 65 (a follow-up visit). At no time did any participant meet criteria for binge-eating disorder. CONCLUSION: Concerns about possible adverse behavioral consequences of dieting should not dissuade primary care providers from recommending modest energy restriction to obese individuals.     

The use of text messaging to improve attendance in primary care: a randomized controlled trial

BACKGROUND: Non-attendance is common in primary care and previous studies have reported that reminders were useful in reducing broken appointments. OBJECTIVE: To determine the effectiveness of a text messaging reminder in improving attendance in primary care. DESIGN: Multicentre three-arm randomized controlled trial. SETTING: Seven primary care clinics in Malaysia. Participants. Patients (or their caregivers) who required follow-up at the clinics between 48 hours and 3 months from the recruitment date. Interventions. Two intervention arms consisted of text messaging and mobile phone reminders 24-48 hours prior to scheduled appointments. Control group did not receive any intervention. Outcome measures. Attendance rates and costs of interventions. RESULTS: A total of 993 participants were eligible for analysis. Attendance rates of control, text messaging and mobile phone reminder groups were 48.1, 59.0 and 59.6%, respectively. The attendance rate of the text messaging reminder group was significantly higher compared with that of the control group (odds ratio 1.59, 95% confidence interval 1.17 to 2.17, P = 0.005). There was no statistically significant difference in attendance rates between text messaging and mobile phone reminder groups. The cost of text messaging reminder (RM 0.45 per attendance) was lower than mobile phone reminder (RM 0.82 per attendance). CONCLUSIONS: Text messaging reminder system was effective in improving attendance rate in primary care. It was more cost-effective compared with the mobile phone reminder.     

Cost-utility analysis of osteopathy in primary care: results from a pragmatic randomized controlled trial

BACKGROUND: Spinal pain is common and costly to health services and society. Management guidelines have encouraged primary care referral for spinal manipulation, but the evidence base is weak. More economic evaluations alongside pragmatic trials have been recommended. OBJECTIVE: Our aim was to assess the cost-utility of a practice-based osteopathy clinic for subacute spinal pain. METHODS: A cost-utility analysis was performed alongside a pragmatic single-centre randomized controlled trial in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. Patients with back pain of 2-12 weeks duration were randomly allocated to treatment with osteopathy plus usual GP care or usual GP care alone. Costs were measured from a National Health Service (NHS) perspective. All primary and secondary health care interventions recorded in GP notes were collected for the study period. We calculated quality adjusted life year (QALY) gains based on EQ-5D responses from patients in the trial, and then cost per QALY ratios. Confidence intervals (CIs) were estimated using non-parametric bootstrapping. RESULTS: Osteopathy plus usual GP care was more effective but resulted in more health care costs than usual GP care alone. The point estimate of the incremental cost per QALY ratio was 3560 pounds (80% CI 542 pounds-77,100 pounds). Sensitivity analysis examining spine-related costs alone and total costs excluding outliers resulted in lower cost per QALY ratios. CONCLUSION: A primary care osteopathy clinic may be a cost-effective addition to usual GP care, but this conclusion was subject to considerable random error. Rigorous multi-centre studies are needed to assess the generalizability of this approach.     

Mothers' attitudes to the randomized controlled trial (RCT): the case of acute lymphoblastic leukaemia (ALL) in children

OBJECTIVES: Survival rates for childhood cancer have improved substantially partly as a result of national and international randomized clinical trials (RCT). However, the decision for families is complex and emotional. Our aim was to describe the views of mothers of children newly diagnosed with ALL regarding consent to randomized controlled trials. DESIGN: Qualitative interview to explore mothers knowledge, and reasons for involving their child in RCTs. Interviews took place in mothers' homes. PARTICIPANTS: Fifty mothers of children with newly diagnosed ALL (age 4-16 years; mean = 7.4) recruited through research nurses at outpatient appointments. RESULTS: All but three families had consented for their child to be treated in the RCT, although there was wide variation in their understanding of the aims, costs and benefits. Most mothers reported the aim of the trial to compare 'old' and 'new' treatments. CONCLUSION: Despite detailed verbal and written information, mothers were poorly informed about the purpose of the trial, and possibility of side effects. Individual preferences for either standard or new treatment were routinely reported. The data raise questions about the extent to which families give truly informed consent to recruitment of their child to an RCT.     

The contribution of plant foods to the vitamin A supply of lactating women in Vietnam: a randomized controlled trial

BACKGROUND: More information is needed on the efficacy of carotenoids from plant foods in improving vitamin A status. OBJECTIVE: We aimed to quantify the efficacy of provitamin A-rich vegetables and fruit in improving vitamin A status. DESIGN: Breastfeeding women in 9 rural communes in Vietnam were randomly allocated to 1 of 4 groups: the vegetable group (n = 73), which ingested 5.6 mg beta-carotene/d from green leafy vegetables; the fruit group (n = 69), which ingested 4.8 mg beta-carotene/d from orange or yellow fruit; the retinol-rich group (n = 70), which ingested 610 microg retinol/d from animal foods and 0.6 mg beta-carotene/d; and the control group (n = 68), which ingested 0.4 mg beta-carotene/d. Meals of groups 1, 2, and 4 contained <30 microg retinol/d. Lunch and dinner were provided 6 d/wk for 10 wk. RESULTS: Mean (95% CI) changes in serum retinol concentrations of the vegetable, fruit, retinol-rich, and control groups were 0.09 (0.03, 0.16), 0.13 (0.07, 0.19), 0.25 (0.17, 0.33), and 0.00 (-0.06, 0.06) micromol/L, respectively. Mean (95% CI) changes in breast-milk retinol concentrations were 0.15 (0.04, 0.27), 0.15 (0.02, 0.28), 0.48 (0.32, 0.64), and -0.06 (-0.21, 0.09) micromol/L, respectively. According to these findings, the equivalent of 1 microg retinol would be 12 microg beta-carotene (95% CI: 8, 22 microg) for fruit and 28 microg beta-carotene (17, 84 microg) for green leafy vegetables. Thus, apparent mean vitamin A activity of carotenoids in fruit and in leafy vegetables was 50% (95% CI: 27%, 75%) and 21% (7%, 35%), respectively, of that assumed. CONCLUSION: The bioavailability of carotenoids from vegetables and fruit is less than previously assumed.     

Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS)

Background  Patients and clinicians report difficulties with the process of informed consent to clinical trials and audiotape audits show that critical information is often omitted or poorly presented. Decision aids (DAs) may assist in improving consent.
Aims  This study piloted a DA booklet for a high priority breast cancer prevention trial, IBIS-II DCIS, which compares the efficacy of an aromatase inhibitor (anastrozole) with tamoxifen in women who have had surgery for ductal carcinoma in situ (DCIS).
Method  Thirty-one Australian women participating in the IBIS-I breast cancer prevention trial and who are currently in follow-up agreed to read the IBIS-II DCIS participant information sheet and the DCIS DA booklet, complete a set of standardized questionnaires, and provide feedback on the DA via a semi-structured phone interview.
Results  Women found the DA helpful in deciding about trial participation, reporting that it aided their understanding over and above the approved IBIS-II DCIS participant information sheet and was not anxiety provoking. Women's understanding of the rationale and methods of clinical trials and the IBIS-II DCIS trial was very good; with more than 80% of items answered correctly. The only areas that were not understood well were the concepts of randomization and blinding.
Conclusions  This study suggests that the DA will be acceptable to and valued by potential participants in the IBIS-II DCIS study. The revised DA is currently being evaluated prospectively in a randomized controlled trial. If successful, such DAs could transform the consent process to large clinical trials and may also reduce dropout rates.     

Translating access into utilization: lessons from the design and evaluation of a health insurance Web site to promote reproductive health care for young women in Massachusetts

Background

Following state-level health care reform in Massachusetts, young women reported confusion over coverage of contraception and other sexual and reproductive health services under newly available health insurance products. To address this gap, a plain-language Web site titled “My Little Black Book for Sexual Health” was developed by a statewide network of reproductive health stakeholders. The purpose of this evaluation was to assess the health literacy demands and usability of the site among its target audience, women ages 18–26 years.

Study Design

We performed an evaluation of the literacy demands of the Web site's written content and tested the Web site's usability in a health communications laboratory.

Results

Participants found the Web site visually appealing and its overall design concept accessible. However, the Web site's literacy demands were high, and all participants encountered problems navigating through the Web site. Following this evaluation, the Web site was modified to be more usable and more comprehensible to women of all health literacy levels.

Conclusions

To avail themselves of sexual and reproductive health services newly available under expanded health insurance coverage, young women require customized educational resources that are rigorously evaluated to ensure accessibility.

Implications

To maximize utilization of reproductive health services under expanded health insurance coverage, US women require customized educational resources commensurate with their literacy skills. The application of established research methods from the field of health communications will enable advocates to evaluate and adapt these resources to best serve their targeted audiences.     

The effect of the Vermont Diabetes Information System on inpatient and emergency room use: results from a randomized trial

OBJECTIVE: To describe the effect of the Vermont Diabetes Information System (VDIS) on hospital and emergency room use DATA SOURCE: Statewide discharge database STUDY DESIGN: Randomized controlled trial of a decision support system for 7,412 adults with diabetes and their 64 primary care providers. DATA COLLECTION/ DATA EXTRACTION: Charges and dates for hospital admissions and emergency room care in Vermont during an average of 32 months of observation. Data from New York hospitals were not available. PRINCIPAL FINDINGS: Patients randomized to VDIS were admitted to the hospital less often than control subjects (0.17 admissions vs. 0.20; P=0.01) and generated lower hospital charges ($3,113 vs. $3,480; P=0.019). VDIS patients also had lower emergency room utilization (0.27 visits vs. 0.36; P<0.0001) and charges ($304 vs. $414; P<0.0001). The intervention was particularly effective in men and in older subjects. CONCLUSIONS: In spite of data limitations that tended to reduce the apparent effect of the system; this randomized, controlled trial showed that VDIS reduces hospitalization and emergency room utilization and expenses.     

The effect of adding Pap smear information to a mammography reminder system in an HMO: results of randomized controlled trial

BACKGROUND: While reminders can promote cancer screening in primary care, little is known about the potential interaction between multiple reminders. METHODS: We conducted a randomized controlled trial to compare the effect of combined Pap smear plus mammogram reminders and mammogram-only reminders among 2471 women 40 years of age or older enrolled in a health maintenance organization serving a predominantly Medicaid-eligible population. Reminders included both a mailed letter for the woman and a medical record prompt. RESULTS: Intervention assignment was unassociated with differences in rates of visitation to family medicine or internal medicine or completion of mammography during the study year. Compared to women assigned to mammogram-only reminder treatment, those assigned to the combined Pap smear plus mammogram reminder intervention were more likely to visit a gynecologist (34% compared to 29%, adjusted odds ratio = 1.33, 95% confidence interval 1.08-1.63) and to complete a Pap smear (30% compared to 23%, adjusted odds ratio = 1.39, 95% confidence interval 1.07-1.89). CONCLUSIONS: In the study setting, the addition of Pap smear to mammography reminders has a procedure-specific effect, increasing gynecology visits and Pap smear use while neither increasing nor decreasing other primary care visits or mammography. We find no evidence of reinforcement or competition between these reminders.     

The efficacy of Web-based and print-delivered computer-tailored interventions to reduce fat intake: results of a randomized, controlled trial

ObjectiveTo test and compare the efficacy of interactive- and print-delivered computer-tailored nutrition education targeting saturated fat intake reduction.DesignA 3-group randomized, controlled trial (2003-2005) with posttests at 1 and 6 months post-intervention.SettingWorksites and 2 neighborhoods in the urban area of Rotterdam.ParticipantsA convenience sample of healthy Dutch adults (n = 442).InterventionsAn interactive, computer-tailored intervention delivered on a CD-ROM (interactive-tailored condition); a print-delivered, computer-tailored intervention (print-tailored condition); and print-delivered, generic information.Main Outcome MeasuresTotal and saturated fat intake (grams/day and percentage-energy) and energy intake per day assessed with validated food frequency questionnaires at 1 and 6 months post-intervention.AnalysisMultilevel linear regression analyses.ResultsMean total fat, saturated fat, and energy intakes were significantly lower in both tailored conditions compared to the generic condition at 1-month follow-up. These differences were still significant for the print-tailored condition at 6-months follow-up. Effects were most pronounced among participants with unfavorable fat intakes at baseline. There were no significant differences between the 2 tailoring conditions.Conclusions and ImplicationsThe results indicate that interactive and print-delivered computer-tailored interventions can have similar short-term effects on fat intake and that the effects of the print-delivered tailored feedback are maintained in the longer term.     

Retraction Note to: The efficacy of Guolin-Qigong on the body-mind health of Chinese women with breast cancer: a randomized controlled trial

Quality of Life Research - This article has been retracted. Please see the Retraction Notice for more detail: https://doi.org/10.1007/s11136-020-02672-6.