Assessment of Intervention Fidelity and Recommendations for Researchers Conducting Studies on the Diagnosis and Treatment of Chronic Cough in the Adult: CHEST Guideline and Expert Panel Report

BACKGROUND: Successful management of chronic cough has varied in the primary research studies in the reported literature. One of the potential reasons relates to a lack of intervention fidelity to the core elements of the diagnostic and/or therapeutic interventions that were meant to be used by the investigators.

METHODS: We conducted a systematic review to summarize the evidence supporting intervention fidelity as an important methodologic consideration in assessing the effectiveness of clinical practice guidelines used for the diagnosis and management of chronic cough. We developed and used a tool to assess for five areas of intervention fidelity. Medline (PubMed), Scopus, and the Cochrane Database of Systematic Reviews were searched from January 1998 to May 2014. Guideline recommendations and suggestions for those conducting research using guidelines or protocols to diagnose and manage chronic cough in the adult were developed and voted upon using CHEST Organization methodology.

RESULTS: A total of 23 studies (17 uncontrolled prospective observational, two randomized controlled, and four retrospective observational) met our inclusion criteria. These articles included 3,636 patients. Data could not be pooled for meta-analysis because of heterogeneity. Findings related to the five areas of intervention fidelity included three areas primarily related to the provider and two primarily related to the patients. In the area of study design, 11 of 23 studies appeared to be underpinned by a single guideline/protocol; for training of providers, two of 23 studies reported training, and zero of 23 reported the use of an intervention manual; and for the area of delivery of treatment, when assessing the treatment of gastroesophageal reflux disease, three of 23 studies appeared consistent with the most recent guideline/protocol referenced by the authors. For receipt of treatment, zero of 23 studies mentioned measuring concordance of patient-interventionist understanding of the treatment recommended, and zero of 23 mentioned measuring enactment of treatment, with three of 23 measuring side effects and two of 23 measuring adherence. The overall average intervention fidelity score for all 23 studies was poor (20.74 out of 48).

CONCLUSIONS: Only low-quality evidence supports that intervention fidelity strategies were used when conducting primary research in diagnosing and managing chronic cough in adults. This supports the contention that some of the variability in the reporting of patients with unexplained or unresolved chronic cough may be due to lack of intervention fidelity. By following the recommendations and suggestions in this article, researchers will likely be better able to incorporate strategies to address intervention fidelity, thereby strengthening the validity and generalizability of their results that provide the basis for the development of trustworthy guidelines.

Do women who intermittently attend breast screening differ from those women who attend every invitation and those who never attend?

OBJECTIVES:

Analysis of screening uptake usually dichotomizes women into attenders and non-attenders, though many women respond positively to some but not all invitations. This paper studies these intermittent attenders.

METHODS:

A cohort of 8,571 women invited for consecutive breast screens in the Northern Ireland Breast Screening Programme were followed in a study linking screening and census records. Multivariate logistic analysis was used to analyze the characteristics of those who attended both times (consistent), once (intermittent or 'one-time only'), or not at all (non-attenders).

RESULTS:

Overall, 15.5% of women attended once and 13.4% were non-attenders. Non-attenders were characteristically disadvantaged (as measured by social renting, car access, and employment status), less likely to be married, and more likely to be healthy. One-time attenders were younger, and suffering poor health, though there was no association with either social renting or employment status. Privately rented accommodation and city living was associated with both one-time attendance and non-attendance.

CONCLUSIONS:

One-time attenders are an important and distinct subgroup of screening invitees in this analysis. Their distinct characteristics suggest that transitory factors, such as change in marital status, ill-health, or addressing difficulties through change of residence are important. These distinct characteristics suggest the need for different approaches to increase attendance, among both intermittent attenders and those not attending at all.

Protocol for a pilot randomised controlled trial of an intervention to increase the use of traffic light food labelling in UK shoppers (the FLICC trial)

Background: Traffic light labelling of foods—a system that incorporates a colour-coded assessment of the level of total fat, saturated fat, sugar and salt on the front of packaged foods—has been recommended by the UK Government and is currently in use or being phased in by many UK manufacturers and retailers. This paper describes a protocol for a pilot randomised controlled trial of an intervention designed to increase the use of traffic light labelling during real-life food purchase decisions.

Methods/design: The objectives of this two-arm randomised controlled pilot trial are to assess recruitment, retention and data completion rates, to generate potential effect size estimates to inform sample size calculations for the main trial and to assess the feasibility of conducting such a trial. Participants will be recruited by email from a loyalty card database of a UK supermarket chain. Eligible participants will be over 18 and regular shoppers who frequently purchase ready meals or pizzas. The intervention is informed by a review of previous interventions encouraging the use of nutrition labelling and the broader behaviour change literature. It is designed to impact on mechanisms affecting belief and behavioural intention formation as well as those associated with planning and goal setting and the adoption and maintenance of the behaviour of interest, namely traffic light label use during purchases of ready meals and pizzas. Data will be collected using electronic sales data via supermarket loyalty cards and web-based questionnaires and will be used to estimate the effect of the intervention on the nutrition profile of purchased ready meals and pizzas and the behavioural mechanisms associated with label use. Data collection will take place over 48 weeks. A process evaluation including semi-structured interviews and web analytics will be conducted to assess feasibility of a full trial.

Discussion: The design of the pilot trial allows for efficient recruitment and data collection. The intervention could be generalised to a wider population if shown to be feasible in the main trial.

A randomized, controlled trial of an intervention promoting cataract surgery acceptance in Rural China:The Guangzhou uptake of surgery trial (GUSTO)

PURPOSE. To evaluate an educational intervention promoting acceptance of cataract surgery in rural China using a randomized controlled design. METHODS. Patients aged 50 years or older with presenting visual acuity (PVA) less than 6/18 in one or both eyes due to cataract were recruited from 26 screening sessions (13 intervention, 13 control) conducted by five rural hospitals in Guangdong, China. At intervention sessions, subjects were shown a 5- minute informational video, and counseled about cataract, surgery, and surgical cost. During screening, all subjects answered questionnaires on knowledge and attitudes about cataract, their finances, and transportation, and were referred for definitive examination if eligible. Study outcomes were acceptance of surgery (principal outcome) and hospital followup. RESULTS. Subjects in the intervention group were younger than controls (P = 0.01), but the groups did not otherwise differ. Among 212 intervention patients and 222 controls, no differences in knowledge and attitude regarding cataract were found. Surgery was accepted by 31.1% of intervention patients and 34.2% of controls (P > 0.50). Predictors of acceptance included younger age, worse logMAR PVA, knowing that cataract can be treated surgically only, greater anticipated loss in income from hospitalization, and greater house floor space per person. Membership in the intervention group was not associated with accepting surgery (odds ratio [OR]=1.11, 95% confidence interval [CI] 0.67-1.84) or hospital follow-up (OR= 1.03, 95% CI = 0.63-1.67). CONCLUSIONS. Educational interventions that successfully impart the knowledge that cataract can be only treated surgically may be more effective in increasing uptake in this setting. © 2012 The Association for Research in Vision and Ophthalmology, Inc.

Ophthalmology. 2011 Dec;118(12):2343-50. doi: 10.1016/j.ophtha.2011.06.016. Epub 2011 Sep 1. Randomized, controlled trial of an educational intervention to promote spectacle use in rural China: the see well to learn well study.

OBJECTIVE: To test an educational intervention promoting the purchase of spectacles among Chinese children. DESIGN: Randomized, controlled trial. PARTICIPANTS: Children in years 1 and 2 of all 20 junior and senior high schools (ages 12-17 years) in 3 rural townships in Guangdong, China. METHODS: Children underwent visual acuity (VA) testing, and parents of participants with presenting VA worse than 6/12 in either eye improving by more than 2 lines with cycloplegic refraction were recommended to purchase glasses. Children at 10 randomly selected schools received a lecture, video, and classroom demonstration promoting spectacle purchase. MAIN OUTCOME MEASURES: Self-reported purchase of spectacles (primary outcome) and observed wear or possession of newly purchased glasses (secondary outcome) at follow-up examinations (mean, 219 ± 87 days after the baseline visit). RESULTS: Among 15 404 eligible children, examinations were completed for 6379 (74.6%) at intervention schools and 5044 (73.6%) at control schools. Spectacles were recommended for 2236 (35.1%) children at intervention schools and for 2212 (43.9%) at control schools. Of these, 417 (25.7%) intervention schools children and 537 (34.0%, P = 0.45) control schools children reported buying glasses. Predictors of purchase in regression models included female gender (P = 0.02), worse uncorrected VA (P < 0.001), and higher absolute value of refractive error (P = 0.001). Neither the rate of self-reported purchase of glasses or observed wear or possession of newly purchased glasses differed between control schools and intervention schools in mixed-effect logistic regression models. Among children not purchasing glasses, 21.7% had better-eye VA of worse than 6/18. CONCLUSIONS: An intervention based on extensive pilot testing and focus groups in the area failed to promote spectacle purchase or wear. The high burden of remaining uncorrected poor vision underscores the need to develop better interventions. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Psychological interventions for children and young people affected by armed conflict or political violence: a systematic literature review.

Youths exposed to armed conflict have a higher prevalence of mental health and psychosocial difficulties. Diverse interventions exist that aim to ameliorate the effect of armed conflict on the psychological and psychosocial wellbeing of conflict affected youths. However, the evidence base for the effectiveness of these interventions is limited. Using standard review methodology, this review aims to address the effectiveness of psychological interventions employed among this population. The search was performed across four databases and grey literature. Article quality was assessed using the Downs and Black Quality Checklist (1998). Where possible, studies were subjected to meta-analyses. The remaining studies were included in a narrative synthesis. Eight studies concerned non clinical populations, while nine concerned clinical populations. Review findings conclude that Group Trauma Focused-Cognitive Behavioural Therapy is effective for reducing symptoms of posttraumatic stress disorder, anxiety, depression and improving prosocial behaviour among clinical cohorts. The evidence does not suggest that interventions aimed at non clinical groups within this population are effective. Despite high quality studies, further robust trials are required to strengthen the evidence base, as a lack of replication has resulted in a limited evidence base to inform practice.

Biomarker responses to folic acid intervention in healthy adults: a meta-analysis of randomized controlled trials

BACKGROUND: The task of revising dietary folate recommendations for optimal health is complicated by a lack of data quantifying the biomarker response that reliably reflects a given folate intake.

OBJECTIVE: We conducted a dose-response meta-analysis in healthy adults to quantify the typical response of recognized folate biomarkers to a change in folic acid intake.

DESIGN: Electronic and bibliographic searches identified 19 randomized controlled trials that supplemented with folic acid and measured folate biomarkers before and after the intervention in apparently healthy adults aged ≥18 y. For each biomarker response, the regression coefficient (β) for individual studies and the overall pooled β were calculated by using random-effects meta-analysis.

RESULTS: Folate biomarkers (serum/plasma and red blood cell folate) increased in response to folic acid in a dose-response manner only up to an intake of 400 μg/d. Calculation of the overall pooled β for studies in the range of 50 to 400 μg/d indicated that a doubling of folic acid intake resulted in an increase in serum/plasma folate by 63% (71% for microbiological assay; 61% for nonmicrobiological assay) and red blood cell folate by 31% (irrespective of whether microbiological or other assay was used). Studies that used the microbiological assay indicated lower heterogeneity compared with studies using nonmicrobiological assays for determining serum/plasma (I(2) = 13.5% compared with I(2) = 77.2%) and red blood cell (I(2) = 45.9% compared with I(2) = 70.2%) folate.

CONCLUSIONS: Studies administering >400 μg folic acid/d show no dose-response relation and thus will not yield meaningful results for consideration when generating dietary folate recommendations. The calculated folate biomarker response to a given folic acid intake may be more robust with the use of a microbiological assay rather than alternative methods for blood folate measurement.