The translation and cultural adaptation of patient-reported outcome measures for a clinical study involving traditional health providers and bio-medically trained practitioners

This study reports on the cultural and language translation of measures for use with Zulu speakers in South Africa. The translation process was purposefully used to integrate our diverse 14 person study team by employing Community Based Participatory Research (CBPR) strategies. Measures included: the Medical Outcomes Study HIV Health Survey (MOS-HIV), Center for Epidemiologic Studies Depression Scale (CES-D), and Perceived Stress Scale (PSS). The translation was made complex by the variation in Zulu dialects across regions and even between two cities only forty-five minutes apart. Carefully conceived translations can simultaneously produce good translations and deepen team members’ understanding of each other.National Center for Complementary and Alternative Medicine gran

A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Lessertia frutescens (L.) Goldblatt and J.C. Manning (syn. Sutherlandia frutescens (L.) R. Br.) in HIV-infected South Africans : Protocol

Protocol Number: TICIPS002_RP01NIH: National Center for Complementary and Alternative MedicinesFogarty International CenterSponsor: National Center for Complementary and Alternative Medicine National Institutes of Health (http://nccam.nih.gov)On July 9, 2015, the file was updated from the 2009-12 version to Version 7.5 (Protocol Revision Date April 05, 2010)

Development and validation of the Alcohol-Related God Locus of Control Scale

Abstract Control beliefs and spirituality appear to be important factors in recovery from alcoholism. However, the integration of these two constructs has received little attention, and the relationship of spiritually related control beliefs to recovery remains unclear. Currently no measures exist to specifically assess these beliefs. To address this need, the Alcohol-Related God Locus of Control scale (AGLOC) was developed. This 12-item self-report measure assesses perceptions of God/Higher Power's role in recovery from alcoholism. The AGLOC was administered to 144 recovering alcoholics attending Alcoholics Anonymous meetings. Exploratory factor analysis yielded a twofactor solution with one factor related to attributions of God control over initial cessation of drinking (Cessation) and the other factor related to attributions of God control over one's continued maintenance of sobriety (Maintenance). Both subscales and the overall scale demonstrated adequate to high internal consistency. Demonstrating convergent and discriminant validity, the total AGLOC scale and the Cessation subscale were significantly but moderately correlated with spirituality (both frequency and importance), and independent of perceptions of internal control over drinking. Maintenance subscale scores were inversely associated with internal drinking-related scores and were not associated with spiritual importance or frequency of spiritual practice. Findings support the utility of this instrument for the assessment of alcohol-related God/Higher Power locus of control beliefs in an alcoholic population and suggest the importance of further research on changes in alcoholrelated God control beliefs throughout the course of recovery.

Unannounced telephone pill counts for assessing varenicline adherence in a pilot clinical trial

Nia Thompson1, Niaman Nazir1, Lisa Sanderson Cox1,2, Babalola Faseru1,2, Kathy Goggin3, Jasjit S Ahluwalia4, Nicole L Nollen1,21University of Kansas School of Medicine, Department of Preventive Medicine and Public Health, Kansas City, KS, USA; 2University of Kansas Cancer Center, Kansas City, KS, USA; 3University of Missouri-Kansas City, Department of Psychology, Kansas City, MO, USA; 4University of Minnesota Medical School, Department of Medicine and Center for Health Equity, Minneapolis, MN, USABackground: Despite consistent evidence linking smoking cessation pharmacotherapy adherence to better outcomes, knowledge about objective adherence measures is lacking and little attention is given to monitoring pharmacotherapy use in smoking cessation clinical trials.Objectives: To examine unannounced telephone pill counts as a method for assessing adherence to smoking cessation pharmacotherapy.Research design: Secondary data analysis of a randomized pilot study.Participants: 46 moderate-to-heavy (>10 cigarettes per day) African-American smokers.Main measures: Smokers received 1 month of varenicline (Pfizer Global Pharmaceuticals, New York, NY) in a pill box at baseline. Unannounced pill counts were completed by telephone 4 days prior to an in-person pill count conducted at Month 1. At both counts, each compartment of the pill box was opened and the number of remaining pills was recorded.Results: Participants were a mean age of 48 years (SD = 13), predominately female (59%), low income (60% < $1800 monthly family income), and smoked an average of 17 (SD = 7) cigarettes per day. A high degree of concordance was observed between the number of pills counted by phone and in-person (rs = 0.94, P < 0.001). Participants with discordant counts (n = 7) had lower varenicline adherence (mean [SD] = 77% [18%] vs 95% [9%], P < 0.0005), but reported better medication adherence in the past (1.0 [0.8] vs 2.8 [1.0], P < 0.0004) than participants with matching phone and in-person counts (n = 39).Conclusion: Unannounced telephone pill counts appear to be a reliable and practical method for measuring adherence to smoking cessation pharmacotherapy.Keywords: medication adherence, African-Americans, smoking cessatio

Motivational Interviewing for encouraging quit attempts among unmotivated smokers: study protocol of a randomized, controlled, efficacy trial

Abstract Background Although the current Clinical Practice Guideline recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition. Methods/Design A sample of adult community resident smokers (N = 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing’s effect on cessation. Discussion This trial will provide the most rigorous evaluation to date of Motivational Interviewing’s efficacy for encouraging unmotivated smokers to make a quit attempt. It will also provide effect-size estimates of MI’s impact on smoking cessation to inform future clinical trials and inform the Clinical Practice Guideline. Trial registration ClinicalTrials.gov NCT01188018http://deepblue.lib.umich.edu/bitstream/2027.42/112923/1/12889_2012_Article_4312.pd

Motivational Interviewing for encouraging quit attempts among unmotivated smokers: Study protocol of a randomized, controlled, efficacy trial.

Abstract Background Although the current Clinical Practice Guideline recommend Motivational Interviewing for use with smokers not ready to quit, the strength of evidence for its use is rated as not optimal. The purpose of the present study is to address key methodological limitations of previous studies by ensuring fidelity in the delivery of the Motivational Interviewing intervention, using an attention-matched control condition, and focusing on unmotivated smokers whom meta-analyses have indicated may benefit most from Motivational Interviewing. It is hypothesized that MI will be more effective at inducing quit attempts and smoking cessation at 6-month follow-up than brief advice to quit and an intensity-matched health education condition. Methods/Design A sample of adult community resident smokers (N = 255) who report low motivation and readiness to quit are being randomized using a 2:2:1 treatment allocation to Motivational Interviewing, Health Education, or Brief Advice. Over 6 months, participants in Motivational Interviewing and Health Education receive 4 individual counseling sessions and participants in Brief Advice receive one brief in-person individual session at baseline. Rigorous monitoring and independent verification of fidelity will assure the counseling approaches are distinct and delivered as planned. Participants complete surveys at baseline, week 12 and 6-month follow-up to assess demographics, smoking characteristics, and smoking outcomes. Participants who decide to quit are provided with a self-help guide to quitting, help with a quit plan, and free pharmacotherapy. The primary outcome is self-report of one or more quit attempts lasting at least 24 hours between randomization and 6-month follow-up. The secondary outcome is biochemically confirmed 7-day point prevalence cessation at 6-month follow-up. Hypothesized mediators of the presumed treatment effect on quit attempts are greater perceived autonomy support and autonomous motivation. Use of pharmacotherapy is a hypothesized mediator of Motivational Interviewing’s effect on cessation. Discussion This trial will provide the most rigorous evaluation to date of Motivational Interviewing’s efficacy for encouraging unmotivated smokers to make a quit attempt. It will also provide effect-size estimates of MI’s impact on smoking cessation to inform future clinical trials and inform the Clinical Practice Guideline. Trial registration ClinicalTrials.gov NCT01188018Peer Reviewe

Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate ‘Lifestyle Africa’

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.Introduction Low and middle-income countries like South Africa are experiencing major increases in burden of non-communicable diseases such as diabetes and cardiovascular conditions. However, evidence-based interventions to address behavioural factors related to these diseases are lacking. Our study aims to adapt the CDC’s National Diabetes Prevention Program (DPP) within the context of an under-resourced urban community in Cape Town, South Africa. Methods/analysis The new intervention (Lifestyle Africa) consists of 17 weekly sessions delivered by trained community health workers (CHWs). In addition to educational and cultural adaptations of DPP content, the programme adds novel components of text messaging and CHW training in Motivational Interviewing. We will recruit overweight and obese participants (body mass index ≥25 kg/m2) who are members of 28 existing community health clubs served by CHWs. In a 2-year cluster randomised control trial, clubs will be randomly allocated to receive the intervention or usual care. After year 1, usual care participants will also receive the intervention and both groups will be followed for another year. The primary outcome analysis will compare percentage of baseline weight loss at year 1. Secondary outcomes will include diabetes and cardiovascular risk indicators (blood pressure, haemoglobin A1C, lipids), changes in self-reported medication use, diet (fat and fruit and vegetable intake), physical activity and health-related quality of life. We will also assess potential psychosocial mediators/moderators as well as cost-effectiveness of the programme. Ethics/dissemination Ethical approval was obtained from the University of Cape Town and Children’s Mercy. Results will be submitted for publication in peer-reviewed journals and training curricula will be disseminated to local stakeholders. Trial registration number NCT03342274

Let\u27s talk about antibiotics: A randomised trial of two interventions to reduce antibiotic misuse

BACKGROUND: Children with acute respiratory tract infections (ARTIs) receive ≈11.4 million unnecessary antibiotic prescriptions annually. A noted contributor is inadequate parent-clinician communication, however, efforts to reduce overprescribing have only indirectly targeted communication or been impractical. OBJECTIVES: Compare two feasible (higher vs lower intensity) interventions for enhancing parent-clinician communication on the rate of inappropriate antibiotic prescribing. DESIGN: Multisite, parallel group, cluster randomised comparative effectiveness trial. Data collected between March 2017 and March 2019. SETTING: Academic and private practice outpatient clinics. PARTICIPANTS: Clinicians (n=41, 85% of eligible approached) and 1599 parent-child dyads (ages 1-5 years with ARTI symptoms, 71% of eligible approached). INTERVENTIONS: All clinicians received 20 min ARTI diagnosis and treatment education. Higher intensity clinicians received an additional 50 min communication skills training. All parents viewed a 90 second antibiotic education video. MAIN OUTCOMES AND MEASURES: Inappropriate antibiotic treatment was assessed via blinded medical record review by study clinicians and a priori defined as prescriptions for the wrong diagnosis or use of the wrong agent. Secondary outcomes were revisits, adverse drug reactions (both assessed 2 weeks after the visit) and parent ratings of provider communication, shared decision-making and visit satisfaction (assessed at end of the visit on Likert-type scales). RESULTS: Most clinicians completed the study (n=38, 93%), were doctors (n=25, 66%), female (n=30, 78%) and averaged 8 years in practice. All parent-child dyad provided data for the main outcome (n=855 (54%) male, n=1043 (53%) CONCLUSIONS AND RELEVANCE: Rate of inappropriate prescribing was low in both arms. Clinician education coupled with parent education may be sufficient to yield low inappropriate antibiotic prescribing rates. The absence of a significant difference between groups indicates that communication principles previously thought to drive inappropriate prescribing may need to be re-examined or may not have as much of an impact in practices where prescribing has improved in recent years. TRIAL REGISTRATION NUMBER: NCT03037112

Cost-effectiveness of Lifestyle Africa: an adaptation of the diabetes prevention programme for delivery by community health workers in urban South Africa

Background Lifestyle Africa is an adapted version of the Diabetes Prevention Program designed for delivery by community health workers to socioeconomically disadvantaged populations in low- and middle-income countries (LMICs). Results from the Lifestyle Africa trial conducted in an under-resourced community in South Africa indicated that the programme had a significant effect on reducing haemoglobin A1c (HbA1c). Objective To estimate the cost of implementation and the cost-effectiveness (in cost per point reduction in HbA1c) of the Lifestyle Africa programme to inform decision-makers of the resources required and the value of this intervention. Methods Interviews were held with project administrators to identify the activities and resources required to implement the intervention. A direct-measure micro-costing approach was used to determine the number of units and unit cost for each resource. The incremental cost per one point improvement in HbA1c was calculated. Results The intervention equated to 71 United States dollars (USD) in implementation costs per participant and a 0.26 improvement in HbA1c per participant. Conclusions Lifestyle Africa reduced HbA1c for relatively little cost and holds promise for addressing chronic disease in LMIC. Decision-makers should consider the comparative clinical effectiveness and cost-effectiveness of this intervention when making resource allocation decisions