Dataset Information

Assessing the validity and reliability of self-report data on contraception use in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial.

ABSTRACT: BACKGROUND:A variety of different approaches to measuring contraceptive use have been used or proposed, either to assess current use or adherence over time, using subjective or objective measures. This paper reports an overview of approaches to measuring adherence to the oral contraceptive, intra-uterine device, sub-dermal implant, and injectable and describes how we assessed contraception use in the MObile Technology for Improved Family Planning (MOTIF) trial in Cambodia. MAIN BODY:We summarise and discuss advantages and disadvantages of different subjective and objective approaches to measuring adherence to the oral contraceptive, intra-uterine device, sub-dermal implant, and injectable such as self-reports, clinic records, electronic monitoring devices, clinical examination and biomarkers. For the MOTIF trial, we did not consider it feasible to measure objective contraception use as many participants lived a long distance from the clinic and we were concerned whether it was appropriate to ask women to return to clinic for a physical examination simply to verify self-report information already provided. We aimed to assess the validity of the four-month data with 50 participants, calculating the sensitivity and specificity of self-reported data compared with objective measurement. For the 46 valid measurements obtained, the sensitivity and specificity was 100% for self-reported contraception use compared to objective measurement but this study had some limitations. To assess reliability of self-report data we compared calendar data collected on effective contraception use at months 1-4 post-abortion, collected separately at four and 12 months. Agreement ranged from 80 to 84% with a kappa statistic ranging from 0·59 to 0·67 indicating fair to good agreement. CONCLUSION:There is no perfect method of assessing contraception use and researchers designing future studies should give consideration of what to measure, for example current use or detailed patterns of use over time, and remain mindful of what will be feasible and acceptable to the study population. Although self-reported data on contraception use are considered less reliable, and prone to social desirability bias, it is often the standard approach for contraception research and provides data comparable to previous studies. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT01823861 . Registered: March 30, 2013.

SUBMITTER: Smith C

PROVIDER: S-EPMC5856309 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Assessing the validity and reliability of self-report data on contraception use in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial.

Smith Chris C Edwards Phil P Free Caroline C

Reproductive health 20180315 1

<h4>Background</h4>A variety of different approaches to measuring contraceptive use have been used or proposed, either to assess current use or adherence over time, using subjective or objective measures. This paper reports an overview of approaches to measuring adherence to the oral contraceptive, intra-uterine device, sub-dermal implant, and injectable and describes how we assessed contraception use in the MObile Technology for Improved Family Planning (MOTIF) trial in Cambodia.<h4>Main body</ ...[more]

PMID: 29544520

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Project description:Loss to follow-up (LTFU) in clinical trials is an important source of bias that can affect statistical power and generalisability of findings. The aim of this paper is to assess factors associated with LTFU in the MObile Technology for Improved Family Planning (MOTIF) trial in Cambodia and compare how the result might have varied using different analytical methods.Follow-up in the MOTIF trial was 86% at 4 months and 66% at 12 months. For the primary analysis, we undertook a complete case analysis, similar to the approach used in similar trials of interventions delivered by mobile phone to increase contraception use. We conducted an exploratory analysis and found that factors associated with LTFU were young age, lower socio-economic status, not planning to use post-abortion contraception, availability of phone credit and not providing additional contact numbers. We then undertook two analyses to estimate the effect of the intervention on the primary outcome at 4 and 12 months for comparison with the complete case analysis. First, we undertook multiple imputation, and second we conducted an analysis treating all participants' LTFU as non-users of contraception.Using multiple imputation, we found that the risk ratio was slightly increased at 4 months and slightly decreased at 12 months compared with the complete case analysis. When counting all participants' LTFU as non-users of contraception, we observed that, compared with the complete case analysis, the risk ratio was slightly decreased at 4 months and slightly increased at 12 months. Despite the changes in the risk ratio, use of the different analytical methods did not result in an effect using the complete case analysis becoming statistically significant or vice versa.Future studies assessing contraception use might anticipate increased attrition amongst younger participants, those of lower socio-economic status or those who do not provide additional contact details. Attrition could be reduced by collecting as many contact details as possible, by providing incentives and possibly by enhanced counselling to groups at higher risk of LTFU on recruitment. Multiple imputation should be considered in addition to complete case analysis if LTFU not missing at random is expected or observed.ClinicalTrials.gov, NCT01823861 . Registered on 30 March 2013.

Project description:Providing women with contraceptive methods following abortion is important to reduce repeat abortion rates, yet evidence for effective post-abortion family planning interventions are limited. This protocol outlines the evaluation of a mobile phone-based intervention using voice messages to support post-abortion family planning in Cambodia.A single blind randomised controlled trial of 500 participants. Clients aged 18 or over, attending for abortion at four Marie Stopes International clinics in Cambodia, owning a mobile phone and not wishing to have a child at the current time are randomised to the mobile phone-based intervention or control (standard care) with a 1:1 allocation ratio.The intervention comprises a series of six automated voice messages to remind clients about available family planning methods and provide a conduit for additional support. Clients can respond to message prompts to request a phone call from a counsellor, or alternatively to state they have no problems. Clients requesting to talk to a counsellor, or who do not respond to the message prompts, receive a call from a Marie Stopes International Cambodia counsellor who provides individualised advice and support regarding family planning. The duration of the intervention is 3 months. The control group receive existing standard of care without the additional mobile phone-based support.We hypothesise that the intervention will remind clients about contraceptive methods available, identify problems with side effects early and provide support, and therefore increase use of post-abortion family planning, while reducing discontinuation and unsafe method switching.Participants are assessed at baseline and at 4 months. The primary outcome measure is use of an effective modern contraceptive method at 4 months post abortion. Secondary outcome measures include contraception use, pregnancy and repeat abortion over the 4-month post-abortion period.Risk ratios will be used as the measure of effect of the intervention on the outcomes, and these will be estimated with 95% confidence intervals. All analyses will be based on the 'intention to treat' principle.This study will provide evidence on the effectiveness of a mobile phone-based intervention using voice messages to support contraception use in a population with limited literacy. Findings could be generalisable to similar populations in different settings.ClinicalTrials.gov Identifier: NCT01823861.

Project description:Introduction:Children with high dental anxiety display uncooperative behavior during dental procedures. Different self-assessment questionnaires are in use to estimate the prevalence of dental fear and anxiety (DFA) in children but they need to be tested for reliability and validity in different populations. Objectives:The aim of this study was to test the reliability and validity of two scales for the assessment of child dental fear and anxiety in a sample of Croatian children. Material and Methods:The sample comprised 202 pairs consisting of children and their mothers (97 boys and 105 girls) aged 5 - 12 years. Two scales were used to assess children's DFA: the Children's Fear Survey Schedule - Dental Subscale (CFSS-DS) and the Modified Child Dental Anxiety Scale - face version (MCDAS-f). The Corah's Dental Anxiety Scale (CDAS) was used in the sample of children's mothers. The average scores of cooperative children and children with behavior management problem (BMP) were compared. Results:Cooperative children displayed significantly lower CFSS-DS scores than children with BMP (M = 28. 46 vs. M = 39. 36; P < 0.001). The average MCDAS-f score was significantly higher in children with BMP than in cooperative children (M = 28. 07 vs. 20. 01; P < 0.001). The CFSS-DS showed high internal consistency (Cronbach's ? = 0. 90), while internal consistency of MCDAS-f was good (? = 0. 73). The maternal CDAS showed good internal consistency (? = 0, 89). The correlations with other self-report measurements of DFS show good validity of all scales. The correlations between CFSS-DS and MCDAS-f were highly significant (r = 0.482; P < 0. 01) as well as the correlations of CFSS-DS and MCDAS-f with CDAS scores (r = 0.223; P < 0. 01 and r = 0.198; P < 0. 01, respectively. Conclusion:The obtained results suggest that both the CFSS-DS scale and the MCDAS-f scale are reliable and valid scales for measuring dental fear and anxiety in children in a sample of Croatian children. The MCDAS-f scale has shown slightly lower internal consistency but it is suitable for use in young children. In addition, the MCDAS-f scale is simple to administer.

Project description:BackgroundFemoral torsion is primarily measured by computed tomography (CT), which has cost and radiation exposure concerns. Recently, femoral anteversion measurement by a simple radiograph-based mobile application was developed for patients with cerebral palsy. This study aimed to validate the use of a mobile application that can reconstruct a three-dimensional model of the femur from conventional radiographs for adults.MethodsMedical records of 76 patients undergoing conventional femur anteroposterior/lateral radiography and femur CT were reviewed. To measure femoral anteversion on the reconstructed 3-dimensional images from both the mobile application and CT, we drew a line which connects the posterior margins of each femoral condyle and another line which passes through the center of the femoral head and the midpoint of the femoral neck. After the reliability test, a single examiner measured femoral anteversion on the mobile application and CT. Pearson's correlation analysis was used to assess the correlation between anteversion on the mobile application and CT.ResultsFemoral anteversion measured on both CT and the mobile application showed excellent reliability (intraclass correlation coefficients: 0.808-0.910). The correlation coefficient between femoral anteversion measured using CT and the mobile application was 0.933 (p < 0.001). The correlation of femoral anteversion between CT and the mobile application was relatively higher in the absence of metallic implants (correlation coefficient: 0.963, p < 0.001) than in the presence of metallic implants (correlation coefficient: 0.878, p < 0.001).ConclusionsUsing two simple radiographs, the mobile application showed excellent validity and reliability for femoral anteversion measurement in adults as compared to CT. With the high accessibility and cost-effectiveness of this mobile application, femoral torsion measurement might be easily performed with simple radiography in clinical settings in the near future.

Dataset Information

Assessing the validity and reliability of self-report data on contraception use in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial.

Publications

Assessing the validity and reliability of self-report data on contraception use in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial.

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