A Comparison of Psychometric Properties Between Internet and Paper Versions of Two Depression Instruments (BDI-II and MADRS-S) Administered to Clinic Patients Development of a questionnaire measuring Attitudes towards Psychological Online Interventions-the APOI. The use of research questionnaires with hearing impaired adults: online vs. paper-and-pencil administration Faked depression: comparing malingering via the internet, pen-and-paper, and telephone administration modes. Improving distress in dialysis (iDiD): a feasibility two-arm parallel randomised controlled trial of an online cognitive behavioural therapy intervention with and without therapist-led telephone support for psychological distress in patients undergoing haemodialysis Methodological Issues in Internet-Mediated Research: A Randomized Comparison of Internet Versus Mailed Questionnaires Targeted Prevention of Common Mental Health Disorders in University Students: Randomised Controlled Trial of a Transdiagnostic Trait-Focused Web-Based Intervention Internet Versus Mailed Questionnaires: A Randomized Comparison The role of psychosocial factors in exclusive breastfeeding to six months postpartum. Clinician-Assisted Internet-Based Treatment is Effective for Depression: Randomized Controlled Trial Development and Validation of the Online Social Support for Smokers Scale The Athlete Sleep Screening Questionnaire: a new tool for assessing and managing sleep in elite athletes A within-subjects trial to test the equivalence of online and paper outcome measures: the Roland Morris Disability Questionnaire Supporting Informed Decision Making for Prostate Specific Antigen (PSA) Testing on the Web: An Online Randomized Controlled Trial Methodological Challenges in Online Trials Anxiety Disorders in Primary Care: Prevalence, Impairment, Comorbidity, and Detection Cluster randomised controlled trial of the e-couch Anxiety and Worry program in schools. Logging On: Evaluating an Online Support Group for Parents of Children with Autism Spectrum Disorders The Men's Safer Sex project: intervention development and feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men. Acceptability of Online Self-Help to People With Depression: Users’ Views of MoodGYM Versus Informational Websites The provision and impact of online patient access to their electronic health records (EHR) and transactional services on the quality and safety of health care: systematic review protocol. Comparing Administration of Questionnaires via the Internet to Pen-and-Paper in Patients with Heart Failure: Randomized Controlled Trial The effectiveness of a web-based self-help intervention to reduce suicidal thoughts: A randomized controlled trial
Background Self-report measures can guide clinical decisions and are useful when evaluating treatment outcomes . However , many clinicians do not use self-report measures systematic ally in their clinical practice . Internet-based question naires could facilitate administration , but the psychometric properties of the online version of an instrument should be explored before implementation . The recommendation from the International Test Commission is to test the psychometric properties of each question naire separately . Objective Our objective was to compare the psychometric properties of paper- and -pencil versions and Internet versions of two question naires measuring depressive symptoms . Methods The 87 participating patients were recruited from primary care and psychiatric care within the public health care system in Sweden . Participants completed the  Beck Depression Inventory ( BDI-II )  and the  Montgomery-Åsberg Depression Rating Scale — Self-rated ( MADRS-S )  , both on paper and on the Internet . The order was r and omized to control for order effects . Symptom severity in the sample ranged from mild to severe depressive symptoms . Results Psychometric properties of the two administration formats were mostly equivalent . The internal consistency was similar for the Internet and paper versions , and significant correlations were found between the formats for both MADRS-S ( r = .84 ) and the BDI-II ( r = .89 ) . Differences between paper and Internet total scores were not statistically significant for either question naire nor for the MADRS-S question dealing with suicidality ( item 9 ) when analyzed separately . The score on the BDI-II question about suicidality ( item 9 ) was significantly lower when administered via the Internet compared with the paper score , but the difference was small ( effect size , Cohen ’s [ d ] = 0.14 ) . There were significant main effects for order of administration on both question naires and significant interaction effects between format and order . This should not , however , pose a problem in clinical use as long as the administration format is not changed when repeated measurements are made . Conclusions The MADRS-S can be transferred to online use without affecting the psychometric properties in a clinical ly meaningful way . The full BDI-II also seems to retain its properties when transferred ; however , the item measuring suicidality in the Internet version needs further investigation since it was associated with a lower score in this study . The use of online question naires offers clinicians a more practical way of measuring depressive symptoms and has the potential to save re sources BACKGROUND Only a minority of people suffering from depression receive adequate treatment . Psychological Online Interventions ( POIs ) could help bridge existing treatment gaps and augment the effectiveness of current treatments . Apart from effectiveness , user acceptance of POIs must be achieved if such interventions are to be broadly implemented in existing health-care . Valid measurement tools examining attitudes towards POIs are lacking . Therefore , we examined the dimensionality of attitudes towards POIs , developed a novel question naire , the Attitudes towards Psychological Online Interventions Question naire ( APOI ) , and gathered data to examine its reliability . METHODS We recruited a sample of 1004 adults with mild to moderate depressive symptoms from a range of sources . We constructed a set of 35 items based on literature review as well as expert and patient queries . The initial items were subjected to an exploratory factor analysis ( EFA ) in a r and omly selected sub sample . A final set of 16 items was subjected to a confirmatory factor analysis ( CFA ) to cross-vali date the factor structure in a separate sub sample . RESULTS The EFA revealed four dimensions : " Scepticism and Perception of Risks " , " Confidence in Effectiveness " , " Technologization Threat " and " Anonymity Benefits " . The model fit in the CFA was excellent relating to all applied indices ( χ(2)=105.816 , p=.651 ; SRMR=.042 ; RMSEA=.013 ; CFI=.994 ) and the APOI total scale showed acceptable to good internal consistency . CONCLUSIONS Further research with the APOI might facilitate the development and dissemination of POIs and , ultimately , help improve the quality of care for people experiencing depressive symptoms Background When evaluating hearing rehabilitation , it is reasonable to use self-report question naires as outcome measure . Question naires used in audiological research are developed and vali date d for the paper- and -pencil format . As computer and Internet use is increasing , st and ardized question naires used in the audiological context should be evaluated to determine the viability of the online administration format . The aim of this study was to compare administration of question naires online versus paper- and pencil of four st and ardised question naires used in hearing research and clinic . We included the Hearing H and icap Inventory for the Elderly ( HHIE ) , the International Outcome Inventory for Hearing Aids ( IOI-HA ) , Satisfaction with Amplification in Daily Life ( SADL ) , and the Hospital Anxiety and Depression Scale ( HADS ) . Methods A cross-over design was used by r and omly letting the participants complete the question naires either online or on paper . After 3 weeks the participants filled out the same question naires again but in the other format . A total of 65 hearing-aid users were recruited from a hearing clinic to participate on a voluntary basis and of these 53 completed both versions of the question naires . Results A significant main effect of format was found on the HHIE ( p < 0.001 ) , with participants reporting higher scores on the online format than in the paper format . There was no interaction effect . For the other question naires were no significant main or interaction effects of format . Significant correlations between the two ways of presenting the measures was found for all question naires ( p<0.05 ) . The results from reliability tests showed Cronbachs α ’s above .70 for all four question naires and differences in Cronbachs α between administration formats were negligible . Conclusions For three of the four included question naires the participants ’ scores remained consistent across administrations and formats . For the fourth included question naire ( HHIE ) a significant difference of format with a small effect size was found . The relevance of the difference in scores between the formats depends on which context the question naire is used in . On balance , it is recommended that the administration format remain stable across assessment points BACKGROUND The Internet and telephone are valuable re sources for mental health practitioners when access to face-to-face assessment or therapy is difficult . However , despite the high stakes ( such as access to medication or financial compensation ) often involved in psychological testing , little is known about how test administration mode influences test scores when patients are malingering . The aim of this research was to examine for the first time the equivalence of a malingered measure of depression when administered over the Internet , over the telephone , and with pen and paper . SUBJECTS AND METHODS A mixed experimental design was used with participants ( n=91 ) r and omly allocated to Internet , telephone , or pen- and -paper groups .  Participants completed the Edinburgh Depression Scale , first under st and ard instructions and then under instructions to fake as if experiencing severe depression . A manipulation check was included to ensure participants had understood and followed instructions to fake . RESULTS As predicted , participants were able to significantly increase their depression scores when asked to fake depression . Participants reported significantly lower faked depression scores over the telephone than in pen- and -paper format . Faked depression scores in the online group did not differ significantly from those in the telephone and pen- and -paper groups . However , participants in all groups met criteria indicative of a provisional diagnosis of depression . CONCLUSIONS Overall , the results indicate that there may be no meaningful difference between malingering across administration modes . If an individual is malingering depression , administration mode has minimal influence . These findings provide preliminary support for the use of online/telephone technologies in the assessment of depression Introduction Psychological distress is common in end-stage kidney disease ( ESKD ) and is associated with poorer health outcomes . Cognitive behavioural therapy ( CBT ) is recommended in UK clinical guidelines for the management of depression in people with long-term conditions . Access to skilled therapists competent in managing the competing mental and physical health dem and s of ESKD is limited . Online CBT treatments tailored to the needs of the ESKD population offers a pragmatic solution for under-re source d services . This study examines the feasibility and acceptability of implementing a two-arm parallel r and omised controlled trial of online CBT with ( intervention arm ) and without ( control arm ) therapist support to improve psychological distress in patients undergoing haemodialysis . Methods Patients will be screened for depression and anxiety while attending for their haemodialysis treatments . We aim to recruit 60 adult patients undergoing haemodialysis who meet criteria for mild to moderately severe symptoms of depression and /or anxiety . Patients will be r and omised individually ( using a 1:1 computerised sequence ratio ) to either online CBT with therapist telephone support ( intervention arm ) , or online CBT with no therapist ( control arm ) . Outcomes include feasibility and acceptability descriptive data on rates of recruitment , r and omisation , retention and treatment adherence . Self-report outcomes include measures of depression ( Patient Health Question naire-9 ) , anxiety ( Generalised Anxiety Disorder-7 ) , quality of life ( Euro-QoL ) , service use ( client service receipt inventory ) and illness cognitions ( brief illness perception question naire ) . A qualitative process evaluation will also be conducted . The statistician will be blinded to treatment allocation . Ethics and dissemination A National Health Service ( NHS ) research ethics committee approved the study . Data from this study will provide essential information for the design and testing of further interventions to ameliorate distress in patients undergoing dialysis . Any amendments to the protocol will be su bmi tted to the NHS committee and study sponsor . Trial registration number NCT023528702 ; Pre- results Background The majority of Internet-mediated studies use measures developed as paper- and -pencil measures or face-to-face-delivered material . Previous research suggests that the equivalence between online and offline measures must be demonstrated rather than assumed . Objective The objective of this study was to explore the equivalence 4 measures completed in an online or offline setting . Methods A sample of students ( n = 1969 ) was r and omly assigned to complete 4 popular scales ( the SF-12v2 , the Hospital Anxiety and Depression Scale ( HADS ) , the Fatigue Symptom Inventory , and a single-item fatigue measure ) either online or by mail survey ( pencil and paper ) . The response rate was 52.51 % ( n = 1034 ) and comparable between the online and offline groups . Results Significant differences were noted in fatigue levels between the online and offline group ( P = .01 ) as measured by the Fatigue Symptom Inventory , with the online sample demonstrating higher levels of fatigue . Equivalency was noted for the SF-12v2 , the Hospital Anxiety and Depression Scale , and the single-item fatigue measure . Internal consistency was high except for the SF-12v2 . The SF-12v2 may not be an ideal measure to use for remote administration . Conclusions Equivalency of the Hospital Anxiety and Depression Scale ( HADS ) and the Physical Component Score and Mental Component Score of the SF-12v2 for online and offline data were demonstrated . Equivalency was not demonstrated for the Fatigue Symptom Inventory . Explanations for the difference in fatigue score between the online and offline sample s are unclear . Research that seeks to match sample s and control for extraneous online and offline variables is called for , along with exploration of factors that may mediate the completion of question naires or alter the respondents ’ relationship with the same , to enhance progress in this area Background A large proportion of university students show symptoms of common mental disorders , such as depression , anxiety , substance use disorders and eating disorders . Novel interventions are required that target underlying factors of multiple disorders . Aims To evaluate the efficacy of a transdiagnostic trait-focused web-based intervention aim ed at reducing symptoms of common mental disorders in university students . Method Students were recruited online ( n = 1047 , age : M = 21.8 , SD = 4.2 ) and categorised into being at high or low risk for mental disorders based on their personality traits . Participants were allocated to a cognitive-behavioural trait-focused ( n = 519 ) or a control intervention ( n = 528 ) using computerised simple r and omisation . Both interventions were fully automated and delivered online ( trial registration : IS RCT N14342225 ) . Participants were blinded and outcomes were self-assessed at baseline , at 6 weeks and at 12 weeks after registration . Primary outcomes were current depression and anxiety , assessed on the Patient Health Question naire ( PHQ9 ) and Generalised Anxiety Disorder Scale ( GAD7 ) . Secondary outcome measures focused on alcohol use , disordered eating , and other outcomes . Results Students at high risk were successfully identified using personality indicators and reported poorer mental health . A total of 520 students completed the 6-week follow-up and 401 students completed the 12-week follow-up . Attrition was high across intervention groups , but comparable to other web-based interventions . Mixed effects analyses revealed that at 12-week follow up the trait-focused intervention reduced depression scores by 3.58 ( p<.001 , 95%CI [ 5.19 , 1.98 ] ) and anxiety scores by 2.87 ( p = .018 , 95%CI [ 1.31 , 4.43 ] ) in students at high risk . In high-risk students , between group effect sizes were 0.58 ( depression ) and 0.42 ( anxiety ) . In addition , self-esteem was improved . No changes were observed regarding the use of alcohol or disordered eating . Conclusions This study suggests that a transdiagnostic web-based intervention for university students targeting underlying personality risk factors may be a promising way of preventing common mental disorders with a low-intensity intervention . Trial Registration ControlledTrials.com IS RCT Background The use of Internet-based question naires for collection of data to evaluate patient education and other interventions has increased in recent years . Many self-report instruments have been vali date d using paper- and -pencil versions , but we can not assume that the psychometric properties of an Internet-based version will be identical . Objectives To look at similarities and differences between the Internet versions and the paper- and -pencil versions of 16 existing self-report instruments useful in evaluation of patient interventions . Methods Participants were recruited via the Internet and volunteered to participate ( N=397 ) , after which they were r and omly assigned to fill out question naires online or via mailed paper- and -pencil versions . The self-report instruments measured were overall health , health distress , practice mental stress management , Health Assessment Question naire ( HAQ ) disability , illness intrusiveness , activity limitations , visual numeric for pain , visual numeric for shortness of breath , visual numeric for fatigue , self-efficacy for managing disease , aerobic exercise , stretching and strengthening exercise , visits to MD , hospitalizations , hospital days , and emergency room visits . Means , ranges , and confidence intervals are given for each instrument within each type of question naire . The results from the two question naires were compared using both parametric and non-parametric tests . Reliability tests were given for multi-item instruments . A separate sample ( N=30 ) filled out identical question naires over the Internet within a few days and correlations were used to assess test-retest reliability . Results Out of 16 instruments , none showed significant differences when the appropriate tests were used . Construct reliability was similar within each type of question naire , and Internet test-retest reliability was high . Internet question naires required less follow-up to achieve a slightly ( non-significant ) higher completion rate compared to mailed question naires . Conclusions Among a convenience sample recruited via the Internet , results from those r and omly assigned to Internet participation were at least as good as , if not better than , among those assigned mailed question naires , with less recruitment effort required . The instruments administered via the Internet appear to be reliable , and to be answered similarly to the way they are answered when they are administered via traditional mailed paper question naires OBJECTIVE to investigate the psychosocial variables associated with the ability to  exclusively breastfeed to six months postpartum . Additionally , to evaluate a conceptual model of psychosocial correlates of exclusive breastfeeding duration . DESIGN online , retrospective question naire . SETTING the question naire was placed online and participants accessed it through social networking sites including groups relating to breastfeeding , motherhood and parenting . Participants were also able to share the link with their own networks . This online setting facilitated recruitment of a wide range of Australian and international participants . PARTICIPANTS 174 women aged 18 years and older who had given birth between six months to two years prior . Participants completed an online question naire , which asked them to report on three time points : pre-pregnancy , during pregnancy and during the first six months postpartum . Data were collected from June to December 2011 . MEASUREMENTS psychometrically vali date d tools such as the breastfeeding Self-Efficacy Scale , Body Attitude Question naire , Depression Anxiety and Stress Scale , Fetal Health Locus of Control Scale , and the brief COPE scale were used to measure psychosocial variables . Additional scales were developed by the research ers and met scale reliability criteria . FINDINGS correlation analyses , t-tests and path analysis were used to statistically analyse the data . Results showed that women who exclusively breast fed to six months postpartum exhibited higher intention to exclusively breastfeed , breastfeeding self-efficacy , comfort breastfeeding in public , perceived physical strength and reported less perceived breastfeeding difficulties . Path analyses indicated that breastfeeding self-efficacy was a strong significant predictor of both exclusive breastfeeding intention and duration . Maternal attitude towards pregnancy ( both during pregnancy and postpartum ) , psychological adjustment and early breastfeeding difficulties were also found to be significant predictors of exclusive breastfeeding intention and duration . KEY CONCLUSIONS psychosocial factors are likely to play a significant role in the maintenance of exclusive breastfeeding for six months post-birth . Future research should adopt a prospect i ve study design to examine the influence of psychosocial factors systematic ally and rigorously . IMPLICATION S FOR PRACTICE longitudinal , prospect i ve studies are needed to further examine the role of psychosocial factors on exclusive breastfeeding outcomes . Interventions , which involve improving psychosocial factors such as breastfeeding self-efficacy , may improve exclusive breastfeeding outcomes Objective : The aim of the present study was to determine the efficacy of an Internet-based clinician-assisted computerized cognitive behavioural treatment ( CaCCBT ) programme for depression . Method : Forty-five individuals meeting diagnostic criteria for depression were r and omly assigned to the Sadness programme or to a  waitlist control group . In the clinician-assisted Sadness programme , participants complete six online lessons , weekly homework assignments , receive weekly email contact from a clinical psychologist , and contribute to a moderated online discussion forum with other participants . An intention-to-treat model was used for data analyses . Results : A total of 20 ( 74 % ) treatment group participants completed all lessons within the 8 week programme , and post-treatment data were collected from 18/27 treatment group and 17/18 waitlist group participants . Treatment group participants reported significantly reduced symptoms of depression as measured by the Beck Depression Inventory – second edition and the Patient Health Question naire – Nine Item . Treatment group participants each received an average of eight email contacts ( 111 min of therapist time ] . Mean within- and between-group effect sizes ( Cohen 's d ) across the two measures of depressive symptoms were 0.98 and 0.75 , respectively . Participants found the treatment programme acceptable and satisfactory . Conclusions : These results replicate those from the pilot trial reported by Perini et al. and are consistent with literature indicating that Internet-based programmes for depression and other mental disorders combined with clinical guidance can result in clinical ly significant improvements . These data provide further support for the development of Internet-based treatment for common mental disorders Background Social networks play an important role in smoking . Provision of social support during cessation is a cornerstone of treatment . Online social networks for cessation are ubiquitous and represent a promising modality for smokers to receive and provide the support necessary for cessation . There are no existing measures specific to  online social support  for smoking cessation . Objective The objective was to develop a measure of  social support  to be used in online smoking cessation treatment research . Methods Initial items for the  Online Social Support for Smokers Scale ( OS4 ) were based on existing theory and scales delineated in various taxonomies . Preliminary field analysis ( N = 73 ) was conducted on 23 initial items to optimize the scale . Further development was conducted on a refined 15-item scale in the context of a large r and omized trial of Internet and telephone cessation treatment with follow-ups at 3 , 6 , 12 , and 18 months . In all , 1326 participants were r and omized to an enhanced Internet arm that included a large online social network ; psychometric analyses employed 3-month follow-up data from those reporting use of the enhanced Internet intervention at least once ( n = 873 ) . Items were subjected to a factor analysis , and the internal consistency reliability of the scale was examined along with construct and criterion validity . Other measures used in the study included demographics , nicotine dependence , partner support for cessation , general social support , social integration , stress , depression , health status , online community use , Internet use behaviors , intervention satisfaction , and 30-day point prevalence abstinence . Results The final 12-item OS4 scale demonstrated high internal consistency reliability ( Cronbach alphas .86-.89 ) across demographic and smoking strata of interest . The OS4 also demonstrated good construct and criterion validity , with the directionality of the observed associations providing support for most a priori hypotheses . Significant Pearson correlations were observed between the OS4 and the Partner Interaction Question naire ( PIQ ) Positive subscale ( ρ = .24 , P < .001 ) . As hypothesized , participants with the highest OS4 scores were more likely to have actively participated in the enhanced Internet community and to have high levels of satisfaction with the enhanced Internet intervention . In logistic regression analyses , the OS4 was highly predictive of 30-day point-prevalence abstinence at 6 , 12 , and 18 months ( all P values < .001 ) . The odds of abstinence at 6 months rose by 48 % for each st and ard unit increase in online social support ( 95 % confidence interval [ CI ] 1.17 - 1.71 ) , dropping only slightly to 37 % at 12 and 18 months ( 95 % CI 1.17 - 1.59 ) . Conclusions The OS4 is a brief , reliable , and valid instrument for measuring online social support for smoking cessation . Results should be replicated and extended , but this study suggests the OS4 can be used to advance theory , underst and mechanisms , and potentially help to improve the tailoring of Internet-based smoking cessation treatments . It can also inspire development of similar measures for other online health-related intervention research . Trial registration Clinical trials.gov # NCT00282009 ; http:// clinical trials.gov/ct2/show/NCT00282009 ( Archived by WebCite at http://www.webcitation.org/60XNj3xM6 Background / aim The purpose of this study was to develop a subjective , self-report , sleep-screening question naire for elite athletes . This paper describes the development of the Athlete Sleep Screening Question naire ( ASSQ ) . Methods A convenience sample of 60 elite athletes was r and omly distributed into two groups ; 30 athletes completed a survey composed of current psychometric tools , and 30 athletes completed a revised survey and a sleep specialist structured clinical interview . An item analysis was performed on the revised survey with comparison to clinical decisions regarding appropriate intervention based on a sleep specialist assessment . Results A comparison of existing sleep-screening tools with determination of clinical need from a sleep specialist showed low consistency , indicating that current sleep-screening tools are unsuitable for assessing athlete sleep . A new 15-item tool was developed ( ASSQ ) by selecting items from existing tools that more closely associated with the sleep specialist 's review s. Based on test-retest percentage agreement and the κ-statistic , we found good internal consistency and reliability of the ASSQ . To date , 349 athletes have been screened , and 46 ( 13.2 % ) identified as requiring follow-up consultation with a sleep specialist . Results from the follow-up consultations demonstrated that those athletes identified by the ASSQ as abnormal sleepers have required intervention . Conclusions The research developed a new athlete-specific sleep-screening question naire . Our findings suggest that existing sleep-screening tools are unsuitable for assessing sleep in elite athletes . The ASSQ appears to be more accurate in assessing athlete sleep ( based on comparison with expert clinical assessment ) . The ASSQ can be deployed online and provides clinical cut-off scores associated with specific clinical interventions to guide management of athletes ’ sleep disturbance . The next phase of the research is to conduct a series of studies comparing results from the ASSQ to blinded clinical review s and to data from objective sleep monitoring to further establish the validity of the ASSQ as a reliable sleep screening tool for elite athletes Background Augmenting vali date d paper versions of existing outcome measures with an equivalent online version may offer substantial research advantages ( cost , rapidity and reliability ) . However , equivalence of online and paper question naires can not be assumed , nor can acceptability to respondents . The aim was to test whether online and written versions of the Rol and Morris Disability Question naire  ( RMDQ ) , a st and ard measure of functional disability in back pain , are equivalent at both group and individual levels to establish whether they can be used interchangeably . Methods This is a within- participants equivalence study . 167 participants with back pain fully completed both the paper and online versions of the RMDQ  in r and om order . Participants were recruited from a chiropractic clinic and patient support groups in Southern Engl and . Limits of equivalence were pre-defined as 0.5 RMDQ points , the Bl and -Altman range was calculated , and participants ' comments were examined using content analysis . Results The mean score difference was 0.03 ( SD = 1.43 ) , with the 95 % Confidence Interval falling entirely within our limits of equivalence ( -0.19 to 0.25 ) . The Bl and -Altman range was -2.77 to 2.83 RMDQ points . Participants identified unique advantages and disadvantages associated with each version of the RMDQ . Conclusions The group and individual level data suggest that online and paper versions of the RMDQ are equivalent and can be used interchangeably . The Bl and -Altman range appears to reflect the known measurement properties of the RMDQ . Furthermore , participants ' comments confirmed the potential value to be had from offering them the choice of completing the RMDQ online or on paper Background Men considering the prostate specific antigen ( PSA ) test for prostate cancer , an increasingly common male cancer , are encouraged to make informed decisions , as the test is limited in its accuracy and the natural history of the condition is poorly understood . The Web-based PSA decision aid , Prosdex , was developed as part of the UK Prostate Cancer Risk Management Programme in order to help men make such informed decisions . Objectives The aim of this study was to evaluate the effect of the Web-based PSA decision aid , Prosdex , on informed decision making . Methods A Web-based r and omized controlled trial was conducted in South Wales , United Kingdom . Men aged 50 to 75 who had not previously had a PSA test were r and omly allocated to two intervention and two control groups . Participants in the intervention groups either viewed Prosdex or were given a paper version of the text . The main outcome measures were the three components of informed decision making : ( 1 ) knowledge of prostate cancer and PSA , ( 2 ) attitude toward PSA testing , ( 3 ) behavior using a proxy measure , intention to undergo PSA testing . Decisional conflict and anxiety were also measured as was uptake of the PSA test . Outcomes were measured by means of an online question naire for the Prosdex group , the paper version group , and one of two control groups . Six months later , PSA test uptake was ascertained from general practitioners ’ records , and the online question naire was repeated . Results are reported in terms of the Mann-Whitney U-statistic divided by the product of the two sample sizes ( U/mm ) , line of no effect 0.50 . Results Participants were 514 men . Compared with the control group that completed the initial online question naire , men in the Prosdex group had increased knowledge about the PSA test and prostate cancer ( U/mn 0.70 ; 95 % CI 0.62 - 0.76 ) ; less favourable attitudes to PSA testing ( U/mn 0.39 , 95 % CI 0.31 - 0.47 ) ; were less likely to undergo PSA testing ( U/mn 0.40 , 95 % CI 0.32 - 0.48 ) ; and had less decisional conflict ( U/mn 0.32 , 95 % CI 0.25 - 0.40 ) ; while anxiety level did not differ ( U/mn 0.50 , 95 % CI 0.42 - 0.58 ) . For these outcomes there were no significant differences between men in the Prosdex group and the paper version group . However , in the Prosdex group , increased knowledge was associated with a less favourable attitude toward testing ( Spearman rank correlation [ ρ ] = -0.49 , P < .001 ) and lower intention to undergo testing ( ρ = -0.27 , P = .02 ) . After six months , PSA test uptake was lower in the Prosdex group than in the paper version and the question naire control group ( P = .014 ) . Test uptake was also lower in the control group that did not complete a question naire than in the control group that did , suggesting a possible Hawthorne effect of the question naire in favour of PSA testing . Conclusions Exposure to Prosdex was associated with improved knowledge about the PSA test and prostate cancer . Men who had a high level of knowledge had a less favourable attitude toward and were less likely to undergo PSA testing  . Prosdex appears to promote informed decision making regarding the PSA test . Trial Registration IS RCT N48473735 ; http://www.controlled-trials.com/IS RCT N48473735 ( Archived by WebCite at http://www.webcitation.org/5r1TLQ5nK Health care and health care services are increasingly being delivered over the Internet . There is a strong argument that interventions delivered online should also be evaluated online to maximize the trial ’s external validity . Conducting a trial online can help reduce research costs and improve some aspects of internal validity . To date , there are relatively few trials of health interventions that have been conducted entirely online . In this paper we describe the major method ological issues that arise in trials ( recruitment , r and omization , fidelity of the intervention , retention , and data quality ) , consider how the online context affects these issues , and use our experience of one online trial evaluating an intervention to help hazardous drinkers drink less ( DownYourDrink ) to illustrate potential solutions . Further work is needed to develop online trial methodology Context Anxiety and depression are both common in primary care patients , but much less attention has been paid to anxiety . Contribution The authors administered a 7-item anxiety scale ( Generalized Anxiety Disorder [GAD]-7 ) to 965 primary care patients , who also had a structured interview , to detect an anxiety disorder . Of these patients , 19.5 % had at least 1 anxiety disorder . Patients with anxiety had worse functional status , more disability days , and more physician visits , but 41 % were not being treated for any anxiety disorder . The GAD-7 had high sensitivity and good specificity for detecting a generalized anxiety disorder , panic disorder , social anxiety disorder , and posttraumatic stress disorder . Implication s Anxiety disorders are common , underrecognized , and undertreated , but they are easy to detect with a brief question naire . The Editors Anxiety and depression are the 2 most common mental health problems seen in the general medical setting ( 15 ) . Although increasing attention has been paid to anxiety , it still lags far behind depression in terms of research as well as clinical and public health efforts in screening , diagnosis , and treating affected individuals . This is unfortunate given the prevalence of anxiety and its substantial impact on patient functioning , work productivity , and health care costs ( 614 ) . More than 30 million Americans have a lifetime history of anxiety ( 15 ) , and anxiety disorders cost an estimated $ 42 billion dollars per year in the United States alone , counting direct and indirect costs ( 16 ) . The 4 most common anxiety disorders ( excluding simple phobias that seldom present clinical ly ) are generalized anxiety disorder , panic disorder , social anxiety disorder , and posttraumatic stress disorder ( PTSD ) ( 1723 ) . However , despite the substantial disability associated with each anxiety disorder and the availability of effective treatments , only a minority of patients ( 15 % to 36 % ) with anxiety are recognized in primary care ( 24 , 25 ) . In our paper , we analyze results from a large primary carebased anxiety study ( 26 ) to answer several questions . First , what is the prevalence of these 4 anxiety disorders , both individually and concurrent with one another ? Second , how do these disorders compare in functional impairment , health care use , and comorbid depressive and somatic symptom burden ? Third , how effective is a brief anxiety measure in screening for each disorder ? Compared with previous research , our study is particularly well-positioned to ascertain commonalities among anxiety diagnoses that are traditionally considered to be discrete and to determine whether a single measure can be used as a first step , common metric . This is especially salient for the busy , complex primary care setting , in which simplifying initial recognition of mental disorders may in fact make wider efforts at recognition more feasible . Methods Patient Sample The Patient Health Question naire ( PHQ ) anxiety study ( 26 ) was conducted to develop a short measure to assess generalized anxiety disorder .  Patients were enrolled from a research network of 15 primary care sites ( 13 family practice and 2 internal medicine sites ) located in 12 states and administered central ly by Clinvest , Inc. , Springfield , Missouri , from November 2004 to June 2005 . The Generalized Anxiety Disorder (GAD)-7 scale was developed and vali date d in 2149 patients . In the original study , 2982 persons were invited to participate ; of these , 2740 ( 92 % ) completed the 4-page question naire and had no or minimal missing data ( 26 ) . To minimize sampling bias , consecutive patients were approached at each site in clinic sessions until the target quota for that week was achieved . Of the 2740 participants , the first 2149 were used for development and validation of the GAD-7 scale , whereas the last 591 were used to determine the testretest reliability of the scale . Of the 2149 patients in the validation group , 1654 agreed to a telephone interview , of whom 965 were r and omly selected to undergo this interview within 1 week of their clinic visit by 1 of 2 mental health professionals : a clinical psychologist ( with a PhD ) or a senior psychiatric social worker . Contact information was sent by fax to each interviewer , who shuffled the fax sheets received each day and then drew from the stack several participants to interview that day . The 965 interviewed patients comprise the study population for this paper , and compared with the 1184 participants who did not undergo a mental health professional interview , these were more often women ( 69 % vs. 63 % ; P= 0.003 ) and had slightly higher GAD-7 anxiety scores ( 5.7 vs. 5.1 ; P= 0.010 ) but were similar in age , race , and education . Of note , we only used data from the 1184 participants not undergoing a mental health professional interview to derive the GAD-7 ( 26 ) . The study was approved by the Sterling Institutional Review Board . Study Question naire Before seeing their physicians , patients completed a 4-page question naire that included the GAD-7 ( Appendix Figure ) . This scale was shown to have good internal and testretest reliability , as well as convergent , construct , criterion , procedural , and factorial validity for the diagnosis of generalized anxiety disorder ( 26 ) . Scores on the GAD-7 range from 0 to 21 ; scores of 5 , 10 , and 15 represent mild , moderate , and severe anxiety symptoms , respectively . The first 2 items of the GAD-7 represent core anxiety symptoms , and scores on this GAD-2 subscale range from 0 to 6 . Appendix Figure . The Generalized Anxiety Disorder (GAD)-7 scale . The first 2 items constitute the GAD-2 subscale . GAD-7 2006 Pfizer Inc. All rights reserved . Used with permission . The study question naire also included questions about age , sex , education , race or ethnicity , and marital status ; the Medical Outcomes Study Short Form-20 ( SF-20 ) , which measures functional status in 6 domains ( 27 ) ; the 10-item anxiety subscale from the Hopkins Symptom Checklist ( 28 ) ; the PHQ-8 depression scale ( 29 ) ; a 3-item version  of the Social Phobia Inventory ( Mini-SPIN ) ( 30 ) ; the 5-item PHQ panic module ( 25 ) ; and the PHQ-15 somatic symptom scale ( 31 ) . Also , single-item global assessment s of anxiety , depression , and pain based on a scale of 0 ( none ) to 10 ( as bad as you can imagine ) were included . Finally , patients reported the number of physician visits and disability days during the previous 3 months . Structured Psychiatric Interview The 2 mental health professionals , while blinded to the results of the self-report research question naire , conducted structured psychiatric interviews by telephone to establish independent criteria -based diagnoses according to the Diagnostic and Statistical Manual of Mental Disorders , fourth edition ( DSM-IV ) ( 32 ) . The interview consisted of the generalized anxiety disorder , social anxiety disorder , and PTSD sections of the Structured Clinical Interview for DSM-IV ( SCID ) ( 33 ) . Reinterview by telephone was used because of its feasibility in our multisite study and its demonstrated comparability with face-to-face research interviews ( 3436 ) . The 2 mental health professionals based diagnoses of generalized anxiety disorder and PTSD on the SCID interview . For generalized anxiety disorder , some questions were slightly modified to better assess each DSM-IV criterion . They based a diagnosis of social anxiety disorder on whether the patient met SCID diagnostic criteria and had a Mini-SPIN score of 8 or greater , because this improves the accuracy of social anxiety disorder diagnoses ( 37 ) . They based a diagnosis of panic disorder on answering yes to all 5 questions on the PHQ panic module , a threshold that reflects DSM-IV criteria and has been vali date d in both clinical ( 25 ) and population -based ( 38 ) sample s. Statistical Analysis We estimated sample size with respect to sensitivity of the  GAD-7 scale for diagnosing the target disease ( generalized anxiety disorder ) . We needed 60 participants with generalized anxiety disorder to ensure that the total width of the 95 % CI around a sensitivity proportion of 0.80 was no greater than 0.20 . Given that the estimated prevalence of generalized anxiety disorder in the primary care population was 6 % ( 18 ) , we needed a total of 1000 unselected primary care patients to have approximately 60 patients with generalized anxiety disorder . We determined the prevalence of each of the 4 anxiety disorders and compared them in patient demographic characteristics , functional status , psychiatric comorbidity , disability days , and physician visits . Consistent with previous work ( 1 , 26 , 29 , 39 ) , we replaced missing values in a scale with the mean value of the remaining items if 25 % or fewer items were missing . If more than 25 % of items were missing , the sum score was not computed and was counted as missing . The amount of missing data for any individual variable or scale score was very low ( < 1 % ) . The 15 sites did not differ in missing data . In addition to descriptive statistics , we used analysis of covariance to examine associations among each anxiety disorder and the 6 SF-20 functional status scales , self-reported disability days , and physician visitscontrolling for demographic variables ( sex , age , race , and educational level ) and study site . We ran similar models to examine the effect of the number of anxiety disorders . In all models , patients with no anxiety disorder were the reference group . We adjusted pairwise statistical comparisons by using the Bonferroni correction . Because some dependent variables displayed a skewed ( but unimodal ) distribution , we also reran the models using the rank transformation of the dependent variables . We examined the operating characteristics ( sensitivity , specificity , and positive likelihood ratio ) for a range of cutoff scores of the GAD-7 and GAD-2 for each anxiety disorder . We conducted receiver-operating characteristic curve analyses to determine the area under the curve ( AUC ) for each anxiety disorder . We calculated AUCs and performed statistical comparisons ( GAD-7 vs. BACKGROUND Anxiety is a common mental health problem in youth . The current study aim ed to test the effectiveness of an online self-directed anxiety prevention program in a school-based sample and to compare two methods of implementing an anxiety program in schools . METHODS A three-arm cluster stratified r and omised controlled trial was conducted with 30 Australian schools . Each school was r and omly assigned to receive : ( 1 ) externally-supported intervention , ( 2 ) teacher-supported intervention , or ( 3 ) wait-list control .  All consenting students ( N=1767 ) were invited to complete pre-intervention , post-intervention , 6- and 12-month follow-up question naires measuring generalised anxiety , social anxiety , anxiety sensitivity , depressive symptoms and mental wellbeing . Intervention participants completed the e-couch Anxiety and Worry program over 6 weeks . RESULTS At post-intervention , 6- and 12-month follow-up no significant differences were observed between the intervention and control conditions for generalised anxiety ( Cohen 's d=-0.14 to 0.15 ) , social anxiety ( d=0.04 - 0.23 ) , anxiety sensitivity ( d=-0.07 to 0.07 ) , depressive symptoms ( d=-0.05 to 0.04 ) or mental wellbeing ( d=-0.06 to -0.30 ) . LIMITATIONS The current study only included self-report measures that may have been influenced by situational factors or biases . CONCLUSIONS The e-couch Anxiety and Worry program did not have a significant positive effect on participant mental health or wellbeing . The addition of a mental health education officer to support classroom teachers in the delivery of the program also had no effect on intervention outcomes . Future prevention research should look to develop briefer and more interactive interventions that are more engaging for youth Twenty mothers participated in an online support group for parents of children with autism spectrum disorders . Twenty-five unrelated parents participated in a no-treatment control group . The participants completed online question naires prior to and following the 4-month support group , to evaluate changes in mood , anxiety , parenting stress , and positive perceptions . No significant differences between the groups or across time were found . However , parents who participated in the group reported being satisfied with the support they received and finding the group helpful . Issues related to participant recruitment and retention are discussed . Further research is required to investigate the efficacy of online support groups for parents of children with ASD BACKGROUND This report details the development of the Men 's Safer Sex website and the results of a feasibility r and omised controlled trial ( RCT ) , health economic assessment and qualitative evaluation . OBJECTIVES ( 1 ) Develop the Men 's Safer Sex website to address barriers to condom use ; ( 2 ) determine the best design for an online RCT ; ( 3 ) inform the methods for collecting and analysing health economic data ; ( 4 ) assess the Sexual Quality of Life ( SQoL ) question naire and European Quality of Life-5 Dimensions , three-level version ( EQ-5D-3L ) to calculate quality -adjusted life-years ( QALYs ) ; and ( 5 ) explore clinic staff and men 's views of online research methodology . METHODS ( 1 ) Website development : we combined evidence from research literature and the views of experts ( n = 18 ) and male clinic users ( n = 43 ) ; ( 2 ) feasibility RCT : 159 heterosexually active men were recruited from three sexual health clinics and were r and omised by computer to the Men 's Safer Sex website plus usual care ( n = 84 ) or usual clinic care only ( n = 75 ) . Men were invited to complete online question naires at 3 , 6 , 9 and 12 months , and sexually transmitted infection ( STI ) diagnoses were recorded from clinic notes at 12 months ; ( 3 ) health economic evaluation : we investigated the impact of using different question naires to calculate utilities and QALYs ( the EQ-5D-3L and SQoL question naire ) , and compared different methods to collect re source use ; and ( 4 ) qualitative evaluation : thematic analysis of interviews with 11 male trial participants and nine clinic staff , as well as free-text comments from online outcome question naires . RESULTS ( 1 ) Software errors and clinic Wi-Fi access presented significant challenges . Response rates for online question naires were poor but improved with larger vouchers ( from 36 % with £ 10 to 50 % with £ 30 ) . Clinical records were located for 94 % of participants for STI diagnoses . There were no group differences in condomless sex with female partners [ incidence rate ratio ( IRR ) 1.01 , 95 % confidence interval ( CI ) 0.52 to 1.96 ] . New STI diagnoses were recorded for 8.8 % ( 7/80 ) of the intervention group and 13.0 % ( 9/69 ) of the control group ( IRR 0.75 , 95 % CI 0.29 to 1.89 ) . ( 2 ) Health-care re source data were more complete using patient files than question naires . The probability that the intervention is cost-effective is sensitive to the source of data used and whether or not data on intended pregnancies are included . ( 3 ) The pilot RCT fitted well around clinical activities but 37 % of the intervention group did not see the Men 's Safer Sex website and technical problems were frustrating . Men 's views of the Men 's Safer Sex website and research procedures were largely positive . CONCLUSIONS It would be feasible to conduct a large-scale RCT using clinic STI diagnoses as a primary outcome ; however , technical errors and a poor response rate limited the collection of online self-reported outcomes . The next steps are ( 1 ) to optimise software for online trials , ( 2 ) to find the best ways to integrate digital health promotion with clinical services , ( 3 ) to develop more precise methods for collecting re source use data and ( 4 ) to work out how to overcome barriers to digital intervention testing and implementation in the NHS . TRIAL REGISTRATION Current Controlled Trials IS RCT N18649610 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 20 , No. 91 . See the NIHR Journals Library website for further project information Background Little is known about the factors that influence acceptability of and adherence to  online psychological interventions . Evidence is needed to guide further development of promising programs . Objective Our goal was to investigate users ’ views of two online approaches to self-help for depression : computerized cognitive behavior therapy ( cCBT ) and informational websites , in a workplace context . Computerized CBT offers an inexpensive and accessible alternative to face-to-face therapy , and employers have an interest in reducing the working time lost to depression or stress . Yet little is known about how employees , who have actual experience of using online approaches , judge the intervention as a process . Methods The qualitative data reported here were collected within an online r and omized controlled trial whose participants had diagnosable depression . The experimental intervention was a 5-week cCBT program called MoodGYM , and the control condition was five informational websites about mental health . Data were collected via online question naires . There was no evidence of the superiority of either in terms of treatment outcomes . In parallel , using brief rating scales and open-ended questions design ed for this purpose , we examined the relative acceptability of each approach over time , including perceptions of cCBT compared to seeing a health care professional . Results At least 60 % of participants held online therapy to be at least as acceptable as seeing a professional about mental health issues , and they were more likely to retain this opinion over time if they used the interactive program , MoodGYM , rather than informational websites alone . Barriers to cCBT use fell into four categories : intrinsic , intrapersonal problems ; extrinsic technical problems ; generic issues mostly pertaining to perceptions of cCBT ; and specific issues about the intervention or control condition . These indicate strategies for improving engagement . Conclusions As first-aid for mild to moderate mental health problems , evidence -based computerized approaches have broad acceptability . This could be increased by attending to the barriers noted here and by proactively managing users ’ expectations at individual and organizational levels . The findings have implication s for occupational health providers and others addressing the needs of working-age adults with depression . They also raise method ological issues for online research . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 24529487 ; http://www.controlled-trials.com/IS RCT N24529487 ( Archived by Webcite at http://www.webcitation.org/6O8cCL4mh ) BACKGROUND Innovators have piloted improvements in communication , changed patterns of practice and patient empowerment from online access to electronic health records ( EHR ) . International studies of online services , such as prescription ordering , online appointment booking and secure communications with primary care , show good uptake of email consultations , accessing test results and booking appointments ; when technologies and business process are in place . Online access and transactional services are due to be rolled out across Engl and by 2015 ; this review seeks to explore the impact of online access to health records and other online services on the quality and safety of primary health care . OBJECTIVE To assess the factors that may affect the provision of  online patient access to their EHR and transactional services , and the impact of such access on the quality and safety of health care . METHOD Two review ers independently search ed 11 international data bases during the period 1999 - 2012 . A range of papers including descriptive studies using qualitative or quantitative methods , hypothesis-testing studies and systematic review s were included . A detailed eligibility criterion will be used to shape study inclusion . A team of experts will review these papers for eligibility , extract data using a customised extraction form and use the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) instrument to determine the quality of the evidence and the strengths of any recommendation . Data will then be descriptively summarised and thematically synthesis ed . Where feasible , we will perform a quantitative meta- analysis . Prospero ( International Prospect i ve Register of Systematic Review s ) registration number : crd42012003091 Background The use of the Internet to administer question naires has many potential advantages over the use of pen- and -paper administration . Yet it is important to vali date Internet administration , as most question naires were initially developed and vali date d for pen- and -paper delivery . While some have been vali date d for use over the Internet , these question naires have predominately been used amongst the healthy general population . To date , information is lacking on the validity of question naires administered over the Internet in patients with chronic diseases such as heart failure . Objectives To determine the validity of three heart failure question naires administered over the Internet compared to pen- and -paper administration in patients with heart failure . Methods We conducted a prospect i ve r and omized study using test-retest design comparing administration via the Internet to pen- and -paper administration for three heart failure question naires provided to patients recruited from a heart failure clinic in Toronto , Ontario , Canada : the Kansas City Cardiomyopathy Question naire ( KCCQ )  , the  Minnesota Living with Heart Failure Question naire ( MLHFQ ) , and the Self-Care Heart Failure Index ( SCHFI ) . Results Of the 58 subjects enrolled , 34 completed all three question naires . The mean difference and confidence intervals for the summary scores of the KCCQ , MLHFQ , and SCHFI were 1.2 ( CI -1.5 to 4.0 , scale from 0 to 100 ) , 4.0 ( CI -1.98 to 10.04 , scale from 0 to 105 ) , and 10.1 ( CI 1.18 to 19.07 , scale from 66.7 to 300 ) , respectively . Conclusions Internet administration of the KCCQ appears to be equivalent to pen- and -paper administration . For the MLHFQ and SCHFI , we were unable to demonstrate equivalence . Further research is necessary to determine if the administration methods are equivalent for these instruments Background Suicide , attempted suicide and suicidal thoughts are major public health problems worldwide . Effective face-to-face treatments are Cognitive Behavioural Therapy ( CBT ) , Dialectical Behavioural Therapy ( DBT ) and Problem Solving Treatment ( PST ) . However , about two-thirds of persons who die by suicide have not been in contact with mental health care services in the preceding year , and many have never been treated . Furthermore , many patients do not disclose their suicidal thoughts to their care provider . This may be out of shame , due to fear of stigma or due to lack of trust in ( mental ) health care . Since many suicidal individuals seek information online , the internet provides an opportunity to reach suicidal individuals who would not be contacted otherwise . By providing a self-help intervention online , persons can anonymously learn to gain control over their suicidal thoughts . There is convincing evidence that self-help is effective for a number of mental disorders . In this study the effectiveness for suicidal thoughts is examined . Methods / Design In this study , a recently developed self-help intervention will be evaluated in a R and omized Controlled Trial . The intervention is based on Cognitive Behavioural Therapy and is aim ed at subjects who experience mild to moderate suicidal thoughts . This is defined as a score between 1 and 26 on the Beck Scale for Suicidal Ideation ( BSS ) . Higher and lower scores are excluded . In addition , severely depressed subjects are excluded . In total , 260 subjects will be r and omly allocated to the intervention-condition ( N = 130 ) or to the information-control condition ( N = 130 ) . Self-report question naires will be filled out at baseline , 6 weeks after baseline and 18 weeks after baseline . Primary outcome measure is the reduction in frequency and intensity of suicidal thoughts . Secondary outcome measures are the reduction of hopelessness , anxiety and depression , sleeplessness , worry and quality of life measures . Discussion This study is the first to evaluate the effectiveness of a web-based self-help intervention for suicidal thoughts . Several limitations and strengths of the design are discussed . Trial Registration Netherl and s Trial Register ,
For common instruments such as the CES-D , MADRS-S and HADS there is mounting evidence for adequate psychometric properties .
Background Online question naires for measuring common mental health disorders such as depression and anxiety disorders are increasingly used .
The psychometrics of several pen- and -paper question naires have been re-examined for online use and new online instruments have been developed and tested for validity as well .
This study aims to review and synthesis e the literature on this subject and provide a framework for future research .