Study design - Managing research data | Staff | University ...
left190500ANALYSIS PLANAvailability of shared vs separate places for tobacco and e-cigarette use: Study 1 Contents TOC \o "1-3" \h \z \u Study design PAGEREF _Toc530576124 \h 2Hypotheses PAGEREF _Toc530576125 \h 2Outcomes PAGEREF _Toc530576126 \h 2Primary PAGEREF _Toc530576127 \h 2Secondary PAGEREF _Toc530576128 \h 2Data collection PAGEREF _Toc530576129 \h 2Creating variables PAGEREF _Toc530576130 \h 3Manually creating variables PAGEREF _Toc530576131 \h 3Using SPSS syntax PAGEREF _Toc530576132 \h 3Outliers PAGEREF _Toc530576133 \h 3Missing data PAGEREF _Toc530576134 \h 3Sensitivity analysis PAGEREF _Toc530576135 \h 4Recognising smoking/vaping action PAGEREF _Toc530576136 \h 4Study purpose PAGEREF _Toc530576137 \h 4Attention checks PAGEREF _Toc530576138 \h 4Descriptive statistics PAGEREF _Toc530576139 \h 4Outcome analysis PAGEREF _Toc530576140 \h 4Violations of assumptions PAGEREF _Toc530576141 \h 4Primary outcome PAGEREF _Toc530576142 \h 5Secondary outcomes PAGEREF _Toc530576143 \h 5Exploratory analysis PAGEREF _Toc530576144 \h 5Reporting of the results PAGEREF _Toc530576145 \h 5References PAGEREF _Toc530576146 \h 6Appendix A PAGEREF _Toc530576147 \h 7Appendix B1. PAGEREF _Toc530576148 \h 8Appendix B2. PAGEREF _Toc530576149 \h 12Study designThis is an online study using a 16 group between-subjects design: 2 (smoking status: current smoker, former smoker) × 2 (vaping status: current vaper, non-vaper) × 4 (stimuli type: cigalike, tank-system, tobacco cigarette, control). Participants were recruited according to their smoking / vaping status:Smokers (current smokers, non-vapers)Vapers (former smokers, current vapers)Non-users (former smokers, non-vapers)Dual-users (current smokers, current vapers)Participants were pseudo-randomised to 1 of 4 video stimulus groups (someone smoking; someone using a cigalike e-cigarette; someone using a tank-system e-cigarette; and someone performing a neutral hand to mouth action). Outcome measures (see below) were assessed before and after viewing the videos.HypothesesH1: Smoking urges are higher amongst current and former smokers following exposure to vaping cues (i.e., cigalike and tank system), relative to control cues.H2: Smoking urges are lower amongst current and former smokers following exposure to vaping cues (i.e., cigalike and tank system), relative to smoking cues.H3: Tobacco smoking urges are higher amongst current and former smokers following exposure to cigalike cues, relative to tank system cues. OutcomesPrimaryThe brief Questionnaire of Smoking Urges (QSU) (created from the total of 10 questions, each on a scale 1-7: 1 = ‘strongly disagree’ and 7 = ’strongly agree’). The range of possible scores is from 10 to 70. SecondaryAll: Desire for a regular cigarette / desire for an electronic cigarette (on a scale 0-100: 0 = ‘not at all’ and 100 = ‘most ever’).Smokers: Intentions to quit smoking (five-point scale: 1 = ‘very unlikely’, 2 = ‘unlikely’, 3 = ‘maybe, maybe not’, 4 = ‘likely’, 5 = ‘very likely’).Former smokers: Likelihood to remain abstinent from smoking (five-point scale: 1 = ‘not at all sure’, 2 = ‘slightly sure’, 3 = ‘moderately sure’, 4 = ‘very sure’, 5 = ‘extremely sure’).Data collectionAll data will be sent directly to the researcher completing the data analysis at the end of the study in an Excel spreadsheet. A data dictionary will also be sent which includes all coding and ranges. Creating variables Manually creating variablesManipulation check 1: Create a variable in the Excel spreadsheet that identifies participants who did not correctly identify the smoking/vaping action using Q25, Q30, Q35 and Q40 (‘Please describe what the male actor was doing below’). These questions are string variables, so this will be done manually and will be coded as: 0 = no, they did not identify the action (i.e., make no reference to cigarette or e-cigarette use when appropriate, or misinterpret cigarettes for e-cigarettes or vice versa) and 1 = yes they did identify the action.Manipulation check 2: Create a variable in the Excel spreadsheet that identifies participants who correctly guess the purpose of the study using Q46 (‘Please briefly describe what you think the purpose of this survey was below’). Q46 is a string variable so this will need to be done manually and will be coded as: 0 = no, they did not guess the purpose of the study; and 1 = yes they did guess the purpose of the study (i.e., anything that makes reference to i. a change in desire to smoke/vape, and ii. after seeing someone smoke/vape, see Appendix A for examples).Using SPSS syntax IBM SPSS version 24 will be used to create these variables. All syntax can be seen in Appendix B, but before analysis is started the syntax below must be run in the relevant database and in the correct order.Syntax 1: To recode and create all variables for participant demographics, total smoking urges (pre and post), total vaping urges (pre and post), smoking/vaping status, attention check failure, time as smoker, time as former smoker and video group. Open SPSS file ‘Code 1. Code the variables’ in the relevant study folder and select ‘run all’. Syntax 2: To exclude anyone who lives outside of the UK and anyone who was not randomised to a video group. Open SPSS file ‘Code 2. Selects the current data for analysis’ in the relevant study folder and select ‘run all’.OutliersAny outliers will be identified using range checks, scatter plots and histograms. Outliers should be minimal due to the design of the study but, if any are identified further checks will be performed by the research team to ensure they are not the result of data entry errors. Any outliers will be included in the primary analysis but, if deemed necessary, the analysis will be run both with and without any true outliers to compare results. Missing dataAny missing data will be coded as an impossible value (-999). If an excessive amount of missing data is identified (>10%), the research team will be notified so that checks can be made. The data for the primary outcome should be fully complete due to the nature of the study. However, if missing data is >10% for the outcome variables, and is missing at random, multiple imputation will be used to manage missing data. Results will be reported for complete case data and imputed data. Otherwise (if missing data is <10% for the outcome variables), analysis will be on a complete case basis. Sensitivity analysisRecognising smoking/vaping actionParticipants who did not correctly identify the smoking/vaping action (see Manipulation check 1, above) will be identified and numbers will be compared between each video stimulus group to determine whether any of the four actions in the videos were disproportionately difficult to recognise. A sensitivity analysis of the primary outcome will be run without participants who do not correctly identify the smoking/vaping action. All responses will be included in the final analysis. Study purposeParticipants who guess the purpose of the study will be identified (see Manipulation check 2, above). A sensitivity analysis of the primary outcome will be run without participants who guess the true nature of the study so that any differences can be identified. All responses will be included in the final analysis.Attention checksThere are two attention checks embedded in the questionnaire after randomisation (see Code 1, above). Participants who fail the attention check(s) will be excluded from the main primary analysis. However, to consider generalisability of the results, these participants will be investigated separately, and percentages presented, to identify whether there was a difference in exclusion across video stimulus groups or smoking/vaping status. A sensitivity analysis of the primary outcome will also be run which will include those participants who did fail one or both attention checks.Descriptive statisticsDescriptive statistics will be reported in two tables between all four video stimulus groups, and all four smoking/vaping status groups. Means and standard deviations (SD) will be presented for continuous variables, or median and interquartile ranges for variables with clearly non-normal distributions (see Violations of assumptions, below). Numbers and percentages will be presented for categorical variables.Outcome analysisAll analysis will be done in IBM SPSS version 24. Analysis will be coded in syntax and will be reproducible at any time (this will be added as Appendix C after the analysis is complete).Violations of assumptionsIt is intended, that as per previous literaturePEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XZXN0PC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA [1, 2], the primary outcome (QSU) will be treated as normally distributed data, and analysis will continue accordingly. Normality will however be assessed using normality plots and homogeneity will be assessed using the significance level of the interaction between baseline QSU scores and video stimuli group. This information will be reported but will not change the analysis plan. Primary outcomeThe comparisons in H1-H3 will be explored using a general linear model, incorporating a two-way analysis of covariance (ANCOVA) to compare total QSU scores between both independent variables (smoking status and video stimulus group). Baseline QSU scores will be added as a covariate into the ANCOVA model allowing for adjustment, and post video QSU scores will remain as the outcome. Interactions between vaping and smoking status, and the stimulus groups, will be added to the main effects model to investigate whether the impact of the video stimulus varies according to smoking/ vaping status. Secondary outcomesThe above model will be repeated for the secondary outcome measures below.All participants: Desire for a regular cigaretteAll participants: Desire for an electronic cigaretteCurrent smokers: Intentions to quit smoking Former smokers: Likelihood to remain abstinent from smokingExploratory analysisAny sociodemographic differences in QSU scores between smoking/vaping status groups will also be explored as independent factors in a separate ANCOVA model (adjusting for the baseline QSU score). Reporting of the resultsFor all analysis, the following will be reported for all comparisons: mean values and SD, mean difference (MD) and 95% confidence intervals (CI), F statistic, P-value. References ADDIN EN.REFLIST 1.West, R. and M. Ussher, Is the ten-item Questionnaire of Smoking Urges (QSU-brief) more sensitive to abstinence than shorter craving measures? Psychopharmacology, 2010. 208(3): p. 427-432.2.Toll, B.A., N.A. Katulak, and S.A. McKee, Investigating the factor structure of the Questionnaire on Smoking Urges-Brief (QSU-Brief). Addict Behav, 2006. 31(7): p. 1231-9.Appendix AExample responses to Q46 ‘Please briefly describe what you think the purpose of this survey was below’ that correctly identified the purpose of the study (i.e., coded 1 = yes)‘Not really sure, whether we take notice of the person vaping, and whether this made us want to do it more?’‘Whether or not a person’s desire to smoke/vape increases when you see another person smoking/vaping.’‘To assess whether seeing somebody else vaping affects smokers' cravings.’‘Gauge how the video of vaping alters one desire to vape afterwards’‘To determine whether the sight of seeing someone smoking or vaping changes before or after you see someone doing it’‘I presume that seeing the actor vaping that my desire to do the same would be heightened.’Appendix B1. SPSS Syntax 1: Code the variables (*** indicates a comment only)***labelling of categorical variables *****************to label location variable**VALUE LABELS Q91 "England"2 "Wales"3 "Scotland"4 "Northern Ireland"5 "Other"6 "I do not live in the UK".EXECUTE.**to label gender variable**VALUE LABELS Q101 "Male"2 "Female"3 "Other"4 "Prefer not to say".EXECUTE.**to label education variable**VALUE LABELS Q111 "Higher Education or professional"2 "A levels, vocational level 3 or equivalent"3 "GCSE / O level grade A*-C, vocational level 2 or equivalent"4 "Qualifications at level 1 and below"5 "Other qualifications: level unknown"6 "No qualifications".EXECUTE.**to label smoker variable**VALUE LABELS Q121 "I am a current smoker (smoke at least 5 cigarettes a day and have smoked this amount for at least one year)"2 "I am a former smoker (used to smoke at least 5 cigarettes a day and smoked this amount for at least one year)"3 "I have never smoked (smoker fewer than 100 cigarettes in my lifetime)"4 "Other (smoking experiences do not match the criteria above)".EXECUTE.**to label ‘Are you currently trying to quit smoking’ variable**VALUE LABELS Q141 "Yes"2 "No".EXECUTE.**to label vaping variable**VALUE LABELS Q161 "I am a current vaper (vape at least once a day)"2 "I am a non-vaper (vaped fewer than 20 times in my lifetime)"3 "Other (vaping experiences do not match the criteria above)".EXECUTE.**to label ‘are you planning to quit smoking within the next 6 months?’ variable**VALUE LABELS Q441 "Very unlikely"2 "Unlikely"3 "Maybe / maybe not"4 "Likely"5 "Very unlikely".EXECUTE.**to label ‘How confident are you that you will remain a non-smoker?’ variable**VALUE LABELS Q451 "Not at all sure"2 "Slightly sure"3 "Moderately sure"4 "Very sure"5 "Extremely sure".EXECUTE.**to label ‘Please select what you think the purpose of this survey was from the options below’ variable**VALUE LABELS Q471 "To test memory for conversations"2 "To test the effect of body language on the desire to smoke"3 "To examine the impact of seeing someone smoke on the desire to smoke"4 "To improve the quality of videos used for research".EXECUTE.********calculations to make 'how long' variables into years with one decimal place**********COMPUTE Q13_howlongbeenasmoker=((Q13_1 * 12) + Q13_2) / 12.PUTE Q15_howlongsincequitsmoking=((Q15_1 * 12) + Q15_2) / 12.EXECUTE.******************************adding brief Questionnaire of Smoking Urges together*******COMPUTE QSU_smoking_PRE = Q17_1 + Q17_2 + Q17_3 + Q17_4 + Q17_5 + Q17_6 + Q17_7 + Q17_9 + Q17_10 + Q17_11.PUTE QSU_ecigarette_PRE = Q18_1 + Q18_2 + Q18_3 + Q18_4 + Q18_5 + Q18_6 + Q18_7 + Q18_8 + Q18_9 + Q18_10.PUTE QSU_smoking_POST = Q41_1 + Q41_2 + Q41_3 + Q41_4 + Q41_5 + Q41_6 + Q41_7 + Q41_8 + Q41_9 + Q41_10.PUTE QSU_ecigarette_POST = Q42_1 + Q42_2 + Q42_3 + Q42_5 + Q42_6 + Q42_7 + Q42_8 + Q42_9 + Q42_10 +Q42_11.EXECUTE.***coding the smoking status groups****If Q12 =1 AND Q14 = 2 AND Q16 = 2 Smokinggroups = 1.If Q12 = 2 AND Q16 = 2 Smokinggroups = 2.if Q12 = 2 AND Q16 = 1 Smokinggroups = 3.If Q12 = 1 AND Q14 = 2 AND Q16 = 1 Smokinggroups = 4.EXECUTE.VALUE LABELS Smokinggroups1 "Smokers only"2 "Ex-smokers only"3 "Vapers only"4 "Dual users".EXECUTE.***coding the attention check*****IF (Q17_8 = 4 or Q17_8 = 5 or Q17_8 = 6 or Q17_8 = 7) Attention_check=1.If (Q42_4 = 1 or Q42_4 = 2 or Q42_4 = 3 or Q42_4 =4) Attention_check=1.IF (Q17_8 = 1 or Q17_8 = 2 or Q17_8 =3) Attention_check = 0.if (Q42_4 = 5 or Q42_4 = 6 or Q42_4 = 7) Attention_check = 0.EXECUTE.VALUE LABELS Attention_check0 "Passed attention check"1 "FAILED attention check".EXECUTE.***creating video groups********if sysmis (Q22_1) and sysmis (Q27_1) and sysmis (Q32_1) video_group = 4.if sysmis (Q22_1) and sysmis (Q27_1) and sysmis (Q37_1) video_group = 3.if sysmis (Q22_1) and sysmis (Q32_1) and sysmis (Q37_1) video_group = 2.if sysmis (Q27_1) and sysmis (Q32_1) and sysmis (Q37_1) video_group = 1.if sysmis (Q22_1) and sysmis (Q27_1) and sysmis (Q32_1) and sysmis (Q37_1) video_group = -999. VALUE LABELS video_group1 "Vaping cigalike"2 "Vaping tank"3 "Smoking cigarette"4 "Neutral"-999 "Missing".EXECUTE.Missing values video_group (-999).******combining video questions into one set of time points*****COMPUTE Video_Q1=Q22_1 + Q27_1 + Q32_1 + Q37_1.EXECUTE.VARIABLE LABELS Video_Q1 "Please use the slider to rate the video on the features outlined below - Quality of video picture".COMPUTE Video_Q2=Q22_2 + Q27_2+Q32_2+Q37_2.EXECUTE.VARIABLE LABELS Video_Q2 "Please use the slider to rate the video on the features outlined below - Quality of acting".COMPUTE Video_Q3=Q22_3 + Q27_3 + Q32_3 + Q37_3.EXECUTE.VARIABLE LABELS Video_Q3 "Clarity of the conversation".COMPUTE Video_Q4=Q22_4 + Q27_4 + Q32_4 + Q37_4.EXECUTE.VARIABLE LABELS Video_Q4 "Please use the slider to rate the video on the features outlined below - Level of interest in the conversation".COMPUTE Video_Q5=Q23 + Q28 + Q33 + Q38.EXECUTE.VARIABLE LABELS Video_Q5 "Please record what you can remember about the two people and their conversation below".COMPUTE Video_Q6=Q24 + Q29 + Q34 + Q39.EXECUTE.VARIABLE LABELS Video_6 "To what extent do you agree that the relationship and conversation between the two people was believable?".COMPUTE Video_Q7= Q25+ Q30 + Q35 + Q40.EXECUTE.VARIABLE LABELS Video_Q7 "Please describe what the male actor was doing below".Appendix B2. SPSS Syntax 2: Syntax for selecting data(*** indicates a comment only)***to exclude those living outside the UK****Select if Q9 = 1 OR Q9 = 2 OR Q9 = 3 OR Q9 = 4 OR Q9 = 5.EXECUTE.****to exclude those who do not have a video group, i.e. those who were not randomised*****SELECT IF video_group = 1 OR video_group=2 OR video_group=3 OR video_group=4.EXECUTE. ................
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