WIC Participation and Coping Strategies Adopted by Families During the Infant Formula Shortage Crisis.

BACKGROUND: Availability of benefits and expanded flexibilities to obtain formula, granted by the US Department of Agriculture shortly after the onset of infant formula shortage in February 2022, could have mitigated adverse experiences related to the shortage in Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) families. OBJECTIVE: To examine association of household WIC participation with formula shortage experiences and coping strategies adopted by families using Household Pulse Survey data. DESIGN: Cross-sectional. PARTICIPANTS: The current study utilized Phase 3.7 of the Household Pulse Survey with the following data collection periods: December 9 through 19, 2022, January 4 through 16, 2023, and February 1 through 13, 2023. The primary analytic sample (N = 1,542) consisted of households with income ≤185% of the federal poverty level and children younger than age 18 months. MAIN OUTCOME MEASURES: Experiences and coping strategies during the formula shortage. STATISTICAL ANALYSES: Logistic regression examined associations of WIC participation with odds of being affected by formula shortage and difficulty in obtaining formula during the past week. Among those affected by the shortage, association of WIC participation with odds of utilizing coping strategies was examined. RESULTS: No statistically significant differences were observed in the rates of being affected by formula shortage and having difficulty in obtaining formula during the past week between WIC participants and income-eligible nonparticipants. However, among those affected by the shortage, WIC participation was related to significantly lower odds of using suboptimal practices as a coping strategy (odds ratio 0.38, 95% CI 0.20 to 0.71; P = 0.003). WIC participants also had significantly higher odds of solely changing formula type, brand, or method of receipt (odds ratio 2.63, 95% CI 1.20 to 5.73; P = 0.02). CONCLUSIONS: Findings from this study suggest that WIC participants may have utilized more optimal coping strategies during the infant formula shortage compared with income-eligible nonparticipants. Additional research is needed to determine whether or not these findings could be attributed to expanded flexibilities to maximize formula access among WIC participants during the shortage.

Benefits of Participation in Clinical Trials: An Umbrella Review.

Participation in randomised clinical trials (RCTs) entails taking part in the discovery of effects of health care interventions. The question of whether participants' outcomes are different to those of non-participants remains controversial. This umbrella review was aimed at assessing whether there are health benefits of participation in RCTs, compared to non-participation. After prospective registration (PROSPERO CRD42021287812), we searched the Medline, Scopus, Web of Science and Cochrane Library databases from inception to June 2022 to identify relevant systematic reviews with or without meta-analyses. Data extraction and study quality assessment (AMSTAR-2) were performed by two independent reviewers. Of 914 records, six systematic reviews summarising 380 comparisons of RCT participants with non-participants met the inclusion criteria. In two reviews, the majority of comparisons were in favour of participation in RCTs. Of the total of comparisons, 69 (18.7%) were in favour of participation, reporting statistically significant better outcomes for patients treated within RCTs, 264 (71.7%) comparisons were not statistically significant, and 35 (9.5%) comparisons were in favour of non-participation. None of the reviews found a harmful effect of participation in RCTs. Our findings suggest that taking part in RCTs may be beneficial compared to non-participation.

Characteristics of Participants and Nonparticipants in a Blended Internet-Based Physical Activity Trial for Breast and Prostate Cancer Survivors: Cross-sectional Study.

BACKGROUND: As the number of cancer survivors is increasing, it is important to be able to offer exercise and physical activity (PA)-promoting interventions that are both effective and reasonably accessible. Internet-based interventions are typically less expensive and more accessible alternatives to on-site supervised interventions. Currently, little is known about the characteristics of nonparticipants in PA promotion trials in the cancer survivorship setting, both in general and specifically in trials using internet-supported interventions. OBJECTIVE: This study aims to gain insight into the characteristics associated with nonparticipation in a blended internet-based supported intervention trial to promote PA. METHODS: Breast and prostate cancer survivors, 3-36 months after primary curative treatment, were invited to participate in the PABLO trial; this trial compared an internet-based intervention to enhance PA levels, with or without additional support from a physical therapist, to usual care. Participants and nonparticipants were asked to complete a comprehensive questionnaire assessing sociodemographics, fatigue, and health-related quality of life. Baseline data for participants and nonparticipants were compared using the independent Student t test and chi-square test. RESULTS: The inclusion rate in the trial was 11.03% (137/1242). Of the nonparticipants, 13.95% (154/1104) completed the questionnaire. Participants were more highly educated (P=.04), had a paid job less often (P=.03), and were on sick leave more often (P=.03). They reported less PA per week, both moderate (P=.03) and vigorous (P<.01), before diagnosis and during leisure time (P<.01, effect size [ES]=0.44). They reported a significantly lower stage of change (P≤.01), lower self-efficacy (P<.01, ES=0.61), perceived barriers to PA (P<.01, ES=0.54), and more general fatigue (P<.01, ES=0.60). Participants reported lower health-related quality of life for most domains (ES ranging from 0.34 for mental health to 0.48 for social functioning). No significant differences were found for other sociodemographics, mood state, or attitudes toward or perceived social support for PA. CONCLUSIONS: The participants who self-selected for trial participation reported lower PA levels before diagnosis and a stronger need for support compared with nonparticipants. The trial thus included those patients who might benefit the most from internet-based supportive PA interventions. TRIAL REGISTRATION: Netherlands trial register NTR6911; https://www.trialregister.nl/trial/6733.

Could changing invitation and booking processes help women translate their cervical screening intentions into action? A population-based survey of women's preferences in Great Britain.

OBJECTIVES: Many women who do not attend screening intend to go, but do not get around to booking an appointment. Qualitative work suggests that these 'intenders' face more practical barriers to screening than women who are up-to-date ('maintainers'). This study explored practical barriers to booking a screening appointment and preferences for alternative invitation and booking methods that might overcome these barriers. DESIGN: A cross-sectional survey was employed. SETTING: Great Britain. PARTICIPANTS: Women aged 25-64, living in Great Britain who intended to be screened but were overdue ('intenders', n=255) and women who were up-to-date with screening ('maintainers', n=359). RESULTS: 'Intenders' reported slightly more barriers than 'maintainers' overall (mean=1.36 vs 1.06, t=3.03, p<0.01) and were more likely to think they might forget to book an appointment (OR=2.87, 95% CI: 2.01 to 4.09). Over half of women said they would book on a website using a smartphone (62%), a computer (58%) or via an app (52%). Older women and women from lower social grades were less likely to say they would use online booking methods (all ps <0.05). Women who reported two or more barriers were more likely to say they would use online booking than women who reported none (ps <0.01). CONCLUSIONS: Women who are overdue for screening face practical barriers to booking appointments. Future interventions may assess the efficacy of changing the architecture of the invitation and booking system. This may help women overcome logistical barriers to participation and increase coverage for cervical screening.

Saying yes or no to physical activity - A comparative cohort analysis of patients seeking treatment for Alcohol Use Disorder.

INTRODUCTION: Engaging individuals, suffering from alcohol use disorder (AUD), in a physical activity can be a challenge, and often it is a limitation of the quality of studies on the topic. The aim of the present study is to investigate differences between participants and non-participants in a randomized controlled trial on the effect of physical exercise as add-on to treatment as usual (TAU) to treatment for alcohol use disorder, thereby identifying potential factors that may predict lack of willingness or ability to consider increasing the level of physical activity. METHOD: The Healthy Lifestyle Study was a randomized controlled trial with three arms, of which two included adding physical activities to treatment for AUD as usual. All patients from an outpatient alcohol treatment clinic were invited to participate in the study. 172 accepted participation, and 384 patients either did not show up for information about the study or declined to participate. All patients in the treatment clinic were assessed by means of European Addiction Severity Index (EuropASI). RESULTS: The only predictor of participation in the study was the drinking pattern. Patients, who had been drinking every day for the last 6 months were less likely to participate in the study (OR 0.7 CI 0.4-0.9). Neither somatic nor psychiatric health seemed to impact whether or not the patients participated in the study. CONCLUSION: Non-participants did not differ from participants in this study except in their drinking pattern.

[Key variable combinations for identifying non-participants in the Japan National Health and Nutrition Survey through record linkage with the Comprehensive Survey of Living Conditions].

Objectives　The identification of non-participants in the Japan National Health and Nutrition Survey (NHNS) requires record linkage with its master sample from the Comprehensive Survey of Living Conditions (CSLC). In principle, we can merge individual records between the two surveys by using key identifiers including household ID, but false matches and nonmatches can occur. We examined combinations of key variables for improving record linkage to identify nonparticipants in the NHNS.Methods　We used individual-level data from the NHNS and the CSLC from 1988 to 2015 (except 2012). We extracted from CSLC data individuals in participating unit blocks in the NHNS to merge records between the two surveys. We used four combinations of key variables: prefecture ID, census enumeration district ID, unit block ID, household ID, and household member ID (A); household member ID in A was replaced with sex and birth year and month or age (B); sex and birth year and month or age were added to A (C); two-stage linkage of B and C (D). We classified a sample of individuals into matched participants, unmatched NHNS participants, and unmatched CSLC participants (a proxy for nonparticipants). We compared the percentages of matched NHNS participants and unmatched CSLC participants across the four combinations of key variables.Results　We obtained a sample of 455,854 participants from the CSLC and 335,010 from the NHNS. The percentage of matched NHNS participants was highest in A (the upper 90%), followed by D (the lower 90%), B (the lower 90%), and C (the 80%). Compared to C, the percentage of matched NHNS participants was higher by 8-14 percentage points in A and 5-10 percentage points in B. Compared to B, it was higher by 0.1-0.4 percentage points in D. The percentage of unmatched CSLC participants was highest in C, followed by B, D, and A. The percentage of unmatched CSLC participants increased in D from the 20% level in the late 1980s to around 30% in the 1990s and stayed between the 30% level and the lower 40% level in the 2000s.Conclusion　The highest percentage of accurate matches of NHNS participants was obtained by considering changes in household member ID and incorrect entries on sex and birth year/month and age, and same-sex multiple births. However, there are limitations in handling unmatched participants due to changes in household ID or other reasons. It is therefore necessary to consider the possibility of false nonmatches included in unmatched CSLC participants in regarding them as non-participants in the NHNS.

Individuals at high risk for type 2 diabetes invited to a lifestyle program: characteristics of participants versus non-participants (the HUNT Study) and 24-month follow-up of participants (the VEND-RISK Study).

OBJECTIVE: Prevention of type 2 diabetes mellitus is possible through lifestyle programs, but the effect depends on the program's content, resources, and setting. Lifestyle programs are often confronted with high rates of non-participation and attrition. This study invited individuals at high risk for type 2 diabetes to a lifestyle program in the Norwegian primary healthcare setting. The aims were to investigate possible differences in characteristics between participants and non-participants and to study the effect of the lifestyle program at 24-month follow-up for participants. RESEARCH DESIGN AND METHODS: Individuals identified at high risk for type 2 diabetes during the third survey of the Nord-Trøndelag Health Study (HUNT3) from two municipalities (n=332) were invited to a lifestyle program (the VEND-RISK Study). A cross-sectional design was used to explore if the participants' characteristics differed from non-participants. A non-randomized, single-arm, pre-post examination was used to examine the effect of the lifestyle program on participants' characteristics at 24-month follow-up. RESULTS: Of all individuals at high risk for type 2 diabetes invited to the lifestyle program, 86% (287/332) declined to participate. Non-participating women had fewer years of education (p<0.001), compared with participating women. For men, no differences were seen between non-participants and participants. Among all participants (n=45) at 24-month follow-up, none had developed type 2 diabetes, and HbA1c (p<0.001) had decreased significantly. There was a small reduction in mean body mass index from baseline to 24 months that was not statistically significant. For women, waist circumference (-4.0 cm, p<0.001) decreased significantly. CONCLUSIONS: Future research regarding individuals at high risk for type 2 diabetes in the primary healthcare lifestyle program should focus on how to promote recruitment of women with low education. Participants attending this study's lifestyle program improved their cardiometabolic markers. CLINICAL TRIALS REGISTRATION: NCT01135901; Results.

Motivations for (non)participation in population-based health studies among the elderly - comparison of participants and nonparticipants of a prospective study on influenza vaccination.

BACKGROUND: Participation in epidemiological studies has strongly declined in recent years. We examined the reasons for (non)participation in population-based health studies among participants and nonparticipants of a prospective study on influenza vaccination among the elderly. METHODS: Males and females between 65 and 80 years of age (N = 5582) were randomly selected from the residents' registration office in Hannover, Germany, and were invited to participate in a study featuring vaccination with a seasonal adjuvanted influenza vaccine (Fluad™, Novartis) including five follow-up visits (day 0, 1/3, 7, 21, 70 with respect to vaccination). A 24-item nonresponder questionnaire, including 10 items on reasons for participating in a hypothetical health study, was mailed to 1500 randomly selected nonparticipants. The same 10 items were included in the end-of-study questionnaire administered to the participants in the vaccination study (n = 200). Logistic regression analysis with backward elimination was used to identify the reasons most strongly associated with nonparticipation. RESULTS: Five hundred thirty-one (35%) nonparticipants and 200 participants (100%) returned the respective questionnaires. Nonparticipation was associated with a lower interest in obtaining personal health information (OR = 3.32) and a preference for less invasive (OR = 3.01) and less time-demanding (OR = 2.19) studies. Responses to other items, e.g. regarding altruistic motives, monetary compensation, general interest of the study, or study approval through ethics committee and data security authority, did not differ between participants and nonparticipants. CONCLUSIONS: Participation rates in health studies among elderly individuals could potentially be improved by reducing interventions and time demand, for instance by implementing methods of self-sampling and remote data collection. TRIAL REGISTRATION: No. 1100359 (ClinicalTrials.gov, date of registration: 09.02.2015).

[Acceptance of preventive home visits among frail elderly persons : Participants an non-participants in a Follow-up after 2 and 4 years within the LUCAS longitudinal study]. / Akzeptanz des präventiven Hausbesuchs bei älteren Personen mit Frailty : Teilnehmende und Nichtteilnehmende im Zwei- und Vierjahres-Follow-up im Rahmen der LUCAS-Langzeitstudie.

BACKGROUND: The objective of preventive home visits (PHV) is to support independent living of elderly people. The target group is a matter of discussion and acceptance so far seems to have been low. The target group favored in studies were persons with functional impairments living independently; therefore, acceptance of this offer by frail persons and characteristics of participants and non-participants were studied. MATERIAL AND METHODS: All participants classified as frail in the longitudinal urban cohort ageing study (LUCAS; BMBF Fkz 01ET0708-13/01, ET1002A-D/01EL1407) were randomized (RCT) in 2007/2008 into an intervention group (174 persons) and a control group (379 persons). Participants in the intervention group were offered the option of a PHV. Sociodemographic and health-related characteristics were compared between the participants with a PHV, non-participants and controls at baseline and after 2 and 4 years. Non-participants who refused the offer of the PHV were asked about their reasons. RESULTS: There were 64 persons (36.8 %) in the intervention group classified as frail who accepted the offer of a PHV. Of these, significantly more lived alone, tended to be female with a higher educational level and with less need of care. After 2 years significantly more persons in the group without PHV had died and after 4 years more participants with PHV reported a depressive mood. There were no other significant differences between the groups. Half of the reasons not to accept the PHV that were reported by the non-participants were because of health-related or psychological problems and one third because of lack of interest or need for PHV. CONCLUSION: The offer of PHV to frail elderly persons with an unlimited age was associated with a relatively high acceptance. The high number of refusals by non-participants with functional impairments is remarkable and needs further investigation.

Using multiple imputation to deal with missing data and attrition in longitudinal studies with repeated measures of patient-reported outcomes.

OBJECTIVE: Missing data is a ubiquitous problem in studies using patient-reported measures, decreasing sample sizes and causing possible bias. In longitudinal studies, special problems relate to attrition and death during follow-up. We describe a methodological approach for the use of multiple imputation (MI) to meet these challenges. METHODS: In a cohort of patients treated with percutaneous coronary intervention followed with use of repetitive questionnaires and information from national registers over 3 years, only 417 out of 1,726 patients had complete data on all measure points and covariates. We suggest strategies for use of MI and different methods for dealing with death along with sensitivity analysis of deviations from the assumption of missing at random, all with the use of standard statistical software. The Mental Component Summary from Short Form 12-item survey was used as an example. CONCLUSION: Ignoring missing data may cause bias of unknown size and direction in longitudinal studies. We have illustrated that MI is a feasible method to try to deal with bias due to missing data in longitudinal studies, including attrition and nonresponse, and should be considered in combination with analysis of sensitivity in longitudinal studies. How to handle dropout due to death is still open for debate.

Falls and fractures in participants and excluded non-participants of a fall prevention exercise program for elderly women with a history of falls: 1-year follow-up study.

AIM: To evaluate the effectiveness of a strength and balance enhancing exercise intervention as a means of preventing falls in community-dwelling elderly Japanese women with a history of falls, while comparing functional fitness, fall and fracture rate in excluded subjects. METHODS: A 1-year follow-up trial was carried out on 105 participants over the age of 70 years, who were randomly assigned to the exercise or education group, and also on 91 women excluded based on the exclusion criteria. The exercise group attended a 60-min exercise class twice a week for 3 months. Falls, injuries, fractures, and functional fitness assessments were measured at baseline, post-intervention and 1-year follow up. RESULTS: During the follow up, fall rates were 19.6% in the exercise group, 40.4% in the education group and 40.8% in excluded subjects (χ(2) = 7.069, P = 0.029). Compared with the exercise group, the odds ratio (OR) for falls was greater in the education group (OR 2.78, 95% confidence interval (CI) 1.17-6.96) and excluded participants (OR 2.83, 95%CI 1.25-6.80). The OR for fractures was over fourfold greater in excluded participants (OR 4.30, 95% CI 1.02-9.70) than the exercise group. CONCLUSIONS: The exercise intervention for participants with fall history effectively decreased incidences of falls and fractures. However, fall and fracture rates in excluded people were high. Further research focusing on feasible countermeasures for falls in excluded people who are at high risk of fractures is required.