Search

Background: Sample size calculations require effect size estimations. Sometimes, effect size estimations and standard deviation may not be readily available, particularly if efficacy is unknown because the intervention is new or developing, or the trial targets a new population. In such cases, one way to estimate the effect size is to gather expert opinion. This paper reports the use of a simple strategy to gather expert opinion to estimate a suitable effect size to use in a sample size calculation.Methods: Researchers involved in the design and analysis of clinical trials were identified at the University of Birmingham and via the MRC Hubs for Trials Methodology Research. An email invited them to participate.An online questionnaire was developed using the free online tool 'Survey Monkey©'. The questionnaire described an intervention, an electronic participant information sheet (e-PIS), which may increase recruitment rates to a trial. Respondents were asked how much they would need to see recruitment rates increased by, based on 90%. 70%, 50% and 30% baseline rates, (in a hypothetical study) before they would consider using an e-PIS in their research.Analyses comprised simple descriptive statistics.Results: The invitation to participate was sent to 122 people; 7 responded to say they were not involved in trial design and could not complete the questionnaire, 64 attempted it, 26 failed to complete it. Thirty-eight people completed the questionnaire and were included in the analysis (response rate 33%; 38/115). Of those who completed the questionnaire 44.7% (17/38) were at the academic grade of research fellow 26.3% (10/38) senior research fellow, and 28.9% (11/38) professor. Dependent upon the baseline recruitment rates presented in the questionnaire, participants wanted recruitment rate to increase from 6.9% to 28.9% before they would consider using the intervention.Conclusions: This paper has shown that in situations where effect size estimations cannot be collected from previous research, opinions from researchers and trialists can be quickly and easily collected by conducting a simple study using email recruitment and an online questionnaire. The results collected from the survey were successfully used in sample size calculations for a PhD research study protocol. [ABSTRACT FROM AUTHOR]

In composing multi-thematic questionnaires for the Lolland-Falster Health Study (LOFUS), we faced a range of challenges, for which we found limited guidance in the literature. LOFUS is a household-based population study covering multiple medical and social research areas and targeting the mixed rural-provincial population of 103,000 persons on the Danish islands Lolland and Falster. Households were randomly selected for invitation. In this paper, we describe and discuss challenges in developing the questionnaires related to stakeholders, content of the questionnaire, and the process itself. The development process was characterised by loops of learning and can be described as an iterative and incremental process. We propose recommendations to researchers and administrators involved in similar development processes, including awareness of the non-linearity and complexity of the process, a need for negotiations and navigation among multiple stakeholders, and acknowledgement of pragmatism as an inherent part of decisions made in the process. [ABSTRACT FROM AUTHOR]

Background: The most commonly used survey methods are self-administered questionnaires, telephone interviews, and a mixture of both. But until now evidence out of randomised controlled trials as to whether patient responses differ depending on the survey mode is lacking. Therefore this study assessed whether patient responses to surveys depend on the mode of survey administration. The comparison was between mailed, self-administered questionnaires and telephone interviews. Methods: A four-armed, randomised controlled two-period change-over design. Each patient responded to the same survey twice, once in written form and once by telephone interview, separated by at least a fortnight. The study was conducted in 2003/2004 in Germany. 1087 patients taking part in the German Acupuncture Trials (GERAC cohort study), who agreed to participate in a survey after completing acupuncture treatment from an acupuncture-certified family physician for headache, were randomised. Of these, 823 (664 women) from the ages of 18 to 83 (mean 51.7) completed both parts of the study. The main outcome measure was the comparison of the scores on the 12-Item Short-Form Health Survey (SF-12) and the Graded Chronic Pain Scale (GCPS) questionnaire for the two survey modes. Results: Computer-aided telephone interviews (CATI) resulted in significantly fewer missing data (0.5%) than did mailed questionnaires (2.8%; p < 0.001). The analysis of equivalence revealed a difference between the survey modes only for the SF-12 mental scales. On average, reported mental status score was 3.5 score points (2.9 to 4.0) lower on the self-administered questionnaire compared to the telephone interview. The order of administration affected results. Patients who responded to the telephone interview first reported better mental health in the subsequent paper questionnaire (mean difference 2.8 score points) compared to those who responded to the paper questionnaire first (mean difference 4.1 score points). Conclusion: Despite the comparatively high cost of telephone interviews, they offer clear advantages over mailed self-administered questionnaires as regards completeness of data. Only items concerning mental status were dependent on the survey mode and sequence of administration. Items on physical status were not affected. Normative data for standardized telephone questionnaires could contribute to a better comparability with the results of the corresponding standardized paper questionnaires. [ABSTRACT FROM AUTHOR]

Background: Th EQUATOR Network improves the quality and transparency in health research, primarily by promoting awareness and use of reporting guidelines. In 2018, the UK EQUATOR Centre launched GoodReports.org , a website that helps authors find and use reporting guidelines. This paper describes the tool's development so far. We describe user experience and behaviour of using GoodReports.org both inside and outside a journal manuscript submission process. We intend to use our findings to inform future development and testing of the tool.Methods: We conducted a survey to collect data on user experience of the GoodReports website. We cross-checked a random sample of 100 manuscripts submitted to a partner journal to describe the level of agreement between the tool's checklist recommendation and what we would have recommended. We compared the proportion of authors submitting a completed reporting checklist alongside their manuscripts between groups exposed or not exposed to the GoodReports tool. We also conducted a study comparing completeness of reporting of manuscript text before an author received a reporting guideline recommendation from GoodReports.org with the completeness of the text subsequently submitted to a partner journal.Results: Seventy percent (423/599) of survey respondents rated GoodReports 8 or more out of 10 for usefulness, and 74% (198/267) said they had made changes to their manuscript after using the website. We agreed with the GoodReports reporting guideline recommendation in 84% (72/86) of cases. Of authors who completed the guideline finder questionnaire, 14% (10/69) failed to submit a completed checklist compared to 30% (41/136) who did not use the tool. Of the 69 authors who received a GoodReports reporting guideline recommendation, 20 manuscript pairs could be reviewed before and after use of GoodReports. Five included more information in their methods section after exposure to GoodReports. On average, authors reported 57% of necessary reporting items before completing a checklist on GoodReports.org and 60% after.Conclusion: The data suggest that reporting guidance is needed early in the writing process, not at submission stage. We are developing GoodReports by adding more reporting guidelines and by creating editable article templates. We will test whether GoodReports users write more complete study reports in a randomised trial targeting researchers starting to write health research articles. [ABSTRACT FROM AUTHOR]

Background: To develop a web-based computer adaptive testing (CAT) application for efficiently collecting data regarding workers' perceptions of job satisfaction, we examined whether a 37-item Job Content Questionnaire (JCQ-37) could evaluate the job satisfaction of individual employees as a single construct. Methods: The JCQ-37 makes data collection via CAT on the internet easy, viable and fast. A Rasch rating scale model was applied to analyze data from 300 randomly selected hospital employees who participated in job satisfaction surveys in 2008 and 2009 via non-adaptive and computer-adaptive testing, respectively. Results: Of the 37 items on the questionnaire, 24 items fit the model fairly well. Person-separation reliability for the 2008 surveys was 0.88. Measures from both years and item-8 job satisfaction for groups were successfully evaluated through item-by-item analyses by using t-test. Workers aged 26 - 35 felt that job satisfaction was significantly worse in 2009 than in 2008. Conclusions: A Web-CAT developed in the present paper was shown to be more efficient than traditional computer-based or pen-and-paper assessments at collecting data regarding workers' perceptions of job content. [ABSTRACT FROM AUTHOR]

The article presents a research paper which proposes a new method for evaluating reliability throughout a questionnaire by screening of systematic change in random error. Questionnaires are commonly used for medical and health care research. The paper refers to a simulation study which explores whether systematic change in reliability could be evaluated with the help of unsupervised classification of subjects by cluster analysis (CA) and estimation of intraclass correlation coefficient (ICC).

Background: There is an increasing trend towards lower participation in questionnaire surveys. This reduces representativeness, increases costs and introduces particular challenges to longitudinal surveys, as researchers have to use complex statistical techniques which attempt to address attrition. This paper describes a trial of incentives to retain longitudinal survey cohorts from ages 16 to 20, to question them on the sensitive topic of sexual health. Methods: A longitudinal survey was conducted with 8,430 eligible pupils from two sequential year groups from 25 Scottish schools. Wave 1 (14 years) and Wave 2 (16 years) were conducted largely within schools. For Wave 3 (18 years), when everyone had left school, the sample was split into 4 groups that were balanced across predictors of survey participation: 1) no incentive; 2) chance of winning one of twenty-five vouchers worth £20; 3) chance of winning one £500 voucher; 4) a definite reward of a £10 voucher sent on receipt of their completed questionnaire. Outcomes were participation at Wave 3 and two years later at Wave 4. Analysis used logistic regression and adjusted for clustering at school level. Results: The only condition that had a significant and beneficial impact for pupils was to offer a definite reward for participation (Group 4). Forty-one percent of Group 4 participated in Wave 3 versus 27% or less for Groups 1 to 3. At Wave 4, 35% of Group 4 took part versus 25% or less for the other groups. Similarly, 22% of Group 4 participated in all four Waves of the longitudinal study, whereas for the other three groups it was 16% or less that participated in full. Conclusions: The best strategy for retaining all groups of pupils and one that improved retention at both age 18 and age 20 was to offer a definite reward for participation. This is expensive, however, given the many benefits of retaining a longitudinal sample, we recommend inclusion of this as a research cost for cohort and other repeatcontact studies. [ABSTRACT FROM AUTHOR]

Background: Missing outcome data can lead to bias in the results of systematic reviews. One way to address missing outcome data is by requesting the data from the trial authors, but non-response is common. One way to potentially improve response rates is by sending study participants advance communication. During the update of a systematic review examining the effect of pre-notification on response rates, study authors needed to be contacted for further information. This study was nested within the systematic review by randomising authors to receive a notification of the upcoming request for information. The objective was to test if pre-notification increased response rates.Methods: The participants were study authors included in the systematic review, whose studies were at unclear risk of bias. The intervention was a pre-notification of the request for further information, sent 1 day before the request. The outcome was defined as the proportion of authors who responded to the request for information. Authors were randomised by simple randomisation. Thirty three authors were randomised to the pre-notification arm, and 42 were randomised to the control arm. Authors were blinded to the possibility of an alternative condition.Results: All authors randomised were analysed. 14/33 (42.4%) authors in the pre-notification arm had returned responses to the questionnaire, and 18/42 (42.9%) in the control arm. There was no evidence of a difference between these groups (absolute difference = - 0.5, 95% CI (- 23.4 to 22.5%), p = 1). We received no complaints about receiving the pre-notification.Conclusions: This study's results do not support the hypothesis that pre-notification increases response from study authors being contacted for a request for more information. However, the study has a low power, and the results may not generalise to other contexts, methods of administering a pre-notification, or study populations.Trial Registration: Registration and protocol: This trial is not registered with any trial registry. However, the protocol was posted in advance on the Open Science Framework website and is available on the Open Science Framework website: DOI: https://doi.org/10.17605/OSF.IO/MSV2W or https://osf.io/msv2w/. [ABSTRACT FROM AUTHOR]

Background: A systematic review on the use of incentives to promote questionnaire return in clinical trials suggest they are effective, but not all studies have sufficient funds to use them. Promising an incentive once data are returned can reduce the cost-burden of this approach, with possible further cost-savings if the offer were restricted to reminder letters only. This study aimed to evaluate the effect of promising a monetary incentive at first mailout versus a promise on reminder letters only.Methods: This was a randomised Study Within A Trial (SWAT) nested within BUMPES, a multicentre randomised controlled trial of maternal position in the late stage of labour in women with an epidural. The follow-up questionnaire asked for information on the women's health, wellbeing and health service use one year following the birth of their baby. Women who consented to be contacted were randomised to a promise of a monetary incentive at first mailout or a promise on reminder letters only. Women were given an option of completing the questionnaire on paper or on online. The incentive was posted out on receipt of a completed questionnaire. The primary outcome was the overall return rate, and secondary outcomes were the return rate without any chasing from the study office, and the total cost of the vouchers.Results: A total of 1,029 women were randomised, 508 to the first mailout group and 518 to the reminder group. There was no evidence to suggest a difference between groups in the overall return rate (adjusted RR 1.03 (95 % CI 0.96 to 1.11), however the proportion returned without chasing was higher in the first mailout group (adjusted RR 1.22, 95 % CI 1.07 to 1.39). The total cost of the vouchers per participant was higher in the first mailout group (mean difference £4.56, 95 % CI £4.02 to £5.11).Conclusions: Offering a monetary incentive when a reminder is required could be cost-effective depending on the sample size of the study and the resources available to administer the reminder letters.Trial Registration: The BUMPES Trial is registered with Current Controlled Trials: ISRCTN35706297 , 26(th) August 2009. [ABSTRACT FROM AUTHOR]

Background: Recent developments in psychometric modeling and technology allow pooling well-validated items from existing instruments into larger item banks and their deployment through methods of computerized adaptive testing (CAT). Use of item response theory-based bifactor methods and integrative data analysis overcomes barriers in cross-instrument comparison. This paper presents the joint calibration of an item bank for researchers keen to investigate population variations in general psychological distress (GPD).Methods: Multidimensional item response theory was used on existing health survey data from the Scottish Health Education Population Survey (n = 766) to calibrate an item bank consisting of pooled items from the short common mental disorder screen (GHQ-12) and the Affectometer-2 (a measure of "general happiness"). Computer simulation was used to evaluate usefulness and efficacy of its adaptive administration.Results: A bifactor model capturing variation across a continuum of population distress (while controlling for artefacts due to item wording) was supported. The numbers of items for different required reliabilities in adaptive administration demonstrated promising efficacy of the proposed item bank.Conclusions: Psychometric modeling of the common dimension captured by more than one instrument offers the potential of adaptive testing for GPD using individually sequenced combinations of existing survey items. The potential for linking other item sets with alternative candidate measures of positive mental health is discussed since an optimal item bank may require even more items than these. [ABSTRACT FROM AUTHOR]

Background: There are inherent methodological challenges in the measurement of mental health problems in longitudinal research. There is constant development in definitions, taxonomies and demands concerning the properties of mental health measurements. The aim of this paper was to construct composite measures of mental health problems (according to today's standard) from single questionnaire items devised in the early 1980s, and to evaluate their internal consistency and factorial invariance across the life course using the Northern Swedish Cohort.Methods: All pupils in the last year of compulsory school in Luleå in 1981 (n = 1083) form a prospective cohort study where the participants have been followed with questionnaires from the age of 16 (in 1981) until the age of 43 (in 2008). We created and tested the following composite measures from self-reports at each follow-up: depressive symptoms, anxiety symptoms, functional somatic symptoms, modified GHQ and positive health. Validity and internal consistency were tested by confirmatory factor analysis, including tests of factorial invariance over time.Results: As an overall assessment, the results showed that the composite measures (based on more than 30-year-old single item questions) are likely to have acceptable factorial invariance as well as internal consistency over time.Conclusions: Testing the properties of the mental health measures used in older studies according to the standards of today is of great importance in longitudinal research. Our study demonstrates that composite measures of mental health problems can be constructed from single items which are more than 30 years old and that these measures seem to have the same factorial structure and internal consistency across a significant part of the life course. Thus, it can be possible to overcome some specific inherent methodological challenges in using historical data in longitudinal research. [ABSTRACT FROM AUTHOR]

Background: Using patient-reported outcome measures (PROMs) to assess Quality of Life (QoL) is well established, but commonly-used PROM item-sets do not necessarily capture what all respondents consider important. Measuring complex constructs is particularly difficult in randomised controlled trials (RCTs). The Mother-Generated Index (MGI) is a validated antenatal and postnatal QoL instrument in which the variables and scores are completely respondent-driven. This paper reports on the feasibility and acceptability of the MGI in an RCT, and compares the resulting variables and QoL scores with more commonly used instruments.Methods: The single-page MGI was included at the end of a ten page questionnaire pack and posted to the RCT participants at baseline (28-32 weeks' gestation) and follow-up (six weeks postnatal). Feasibility and acceptability were assessed by ease of administration, data entry and completion rates. Variables cited by women were analysed thematically. MGI QoL scores were compared with outcomes from the EQ-5D-3 L; Edinburgh Postnatal Depression Scale; Satisfaction With Life Scale; and State Trait Anxiety Inventory.Results: Six hundred and seventy eight pregnant women returned the pack at baseline; 668 completed the MGI (98.5%); 383/400 returns at follow up included a completed MGI (95.7%). Quantitative data were scanned into SPSS using a standard data scanning system, and were largely error-free; qualitative data were entered manually. The variables recorded by participants on the MGI forms incorporated many of those in the comparison instruments, and other outcomes commonly used in intrapartum trials, but they also revealed a wider range of issues affecting their quality of life. These included financial and work-related worries; moving house; and concerns over family illness and pets. The MGI scores demonstrated low-to-moderate correlation with other tools (all r values p < .01).Conclusions: Without face-to-face explanation and at the end of a long questionnaire, the MGI was feasible to use, and acceptable to RCT participants. It allowed individual participants to include issues that were important to them, but which are not well captured by existing tools. The MGI unites the explanatory power of qualitative research with the comparative power of quantitative designs, is inexpensive to administer, and requires minimal linguistic and conceptual translation.Trial Registration: ISRCTN27575146 (date assigned 23 March 2011). [ABSTRACT FROM AUTHOR]

Background: An increasing number of research designs are using text messaging (SMS) as a means of self-reported symptom and outcome monitoring in a variety of long-term health conditions, including severity ratings of depressed mood. The validity of such a single item SMS score to measure latent depression is not currently known and is vital if SMS data are to inform clinical evaluation in the future. Methods: A sub-set of depressed participants in the UK ACUDep trial submitted a single SMS text score (R-SMS-DS) between 1 and 9 on how depressed they felt around the same time as completing the PHQ-9 depression questionnaire on paper at 3 months follow-up of the trial. Exploratory categorical data factor analysis (EFA) was used to ascertain the alignment of R-SMS-DS scores with the factor structure of the PHQ-9. Any response bias with regard to age or gender was assessed by differential item functioning (DIF) analysis. Results: Depression scores based on the PHQ-9 and R-SMS-DS at 3 months were available for 337 participants (74 % female; mean age: 42 years, SD=11.1), 213 of which completed the two outcomes within 6 days of each other. R-SMS-DS scores aligned with the underlying latent depression of the PHQ-9 (factor loading of 0.656) and in particular its affective rather than somatic dimension. The R-SMS-DS score was most strongly correlated with depressed mood (r = 0.607), feeling bad about oneself (r = 0.588) and anhedonia (r = 0.573). R-SMS-DS responses were invariant with respect to gender (p = 0.302). However, there was some evidence for age related response bias (p = 0.031), with older participants being more likely to endorse lower R-SMS-DS scores than younger ones. Conclusions: The R-SMS-DS used in the ACUDep trial was found to be a valid measure of latent affective depression with no gender related response bias. This text message item may therefore represent a useful assessment and monitoring tool meriting evaluation in further research. For future study designs we recommend the collection of outcome data by new health technologies in combination with gold standard instruments to ensure concurrent validity. [ABSTRACT FROM AUTHOR]

Background Self-administered questionnaires or interviews and medical records are often used as sources of research data; thus it is essential to evaluate their concordance and reliability. The aim of this paper was to assess the concordance between medical and behavioral data obtained from medical records and interview questionnaires in two correctional facilities. Methods Medical record and interview data were compared for 679 inmates from one male and one female maximum security prison between April 2010 and February 2013. Gender non-stratified and gender-stratified analyses were conducted in SPSS to calculate the prevalence and kappa coefficient scores (κ) for medical (e.g., HIV, diabetes, hypertension) and behavioral (e.g., smoking, drug use, tattoos) conditions. Sensitivity/specificity between medical records and interview were calculated in the gender non-stratified data. Results In the gender non-stratified analysis, κ score for HIV, hepatitis C, diabetes, asthma, and history of tattoos had strong or good concordance (0.66-0.89). Hypertension, renal/kidney disease, cigarette smoking, antibiotic use in the last 6 months, and cocaine use ever were moderately correlated (0.49-0.57). Both history of any illicit drug use ever (0.36) and marijuana use ever (0.23) had poor concordance. Females had higher κ scores and prevalence rates than males overall. Medical conditions were reported more frequently in medical records and behavioral conditions had higher prevalence in interviews. Sensitivity for medical conditions in the combined facility data ranged from 50.0% to 86.0% and 48.2% to 85.3% for behavioral conditions whereas specificity ranged from 95.9% to 99.5% for medical conditions and 75.9% to 92.8% for behavioral conditions. Conclusion Levels of agreement between medical records and self-reports varied by type of factor. Medical conditions were more frequently reported by chart review and behavioral factors more frequently by self-report. Data source used may need to be chosen carefully depending upon the type of information sought. [ABSTRACT FROM AUTHOR]

The article presents a research paper which focuses on a methodological approach used in the pre-validation development of new instruments for measuring outcomes in randomized controlled trials. It discusses the importance of measurement instruments like item generation, item reduction and question formatting. The new method uses the example of the Aberdeen Glaucoma Questionnaire (AGQ) and consists of five steps including generation of a pool of items; item de-duplication and item reduction.

Background: Research questionnaires are not always translated appropriately before they are used in new temporal, cultural or linguistic settings. The results based on such instruments may therefore not accurately reflect what they are supposed to measure. This paper aims to illustrate the process and required steps involved in the cross-cultural adaptation of a research instrument using the adaptation process of an attitudinal instrument as an example. Methods: A questionnaire was needed for the implementation of a study in Norway 2007. There was no appropriate instruments available in Norwegian, thus an Australian-English instrument was cross-culturally adapted. Results: The adaptation process included investigation of conceptual and item equivalence. Two forward and two back-translations were synthesized and compared by an expert committee. Thereafter the instrument was pretested and adjusted accordingly. The final questionnaire was administered to opioid maintenance treatment staff (n=140) and harm reduction staff (n=180). The overall response rate was 84%. The original instrument failed confirmatory analysis. Instead a new two-factor scale was identified and found valid in the new setting. Conclusions: The failure of the original scale highlights the importance of adapting instruments to current research settings. It also emphasizes the importance of ensuring that concepts within an instrument are equal between the original and target language, time and context. If the described stages in the cross-cultural adaptation process had been omitted, the findings would have been misleading, even if presented with apparent precision. Thus, it is important to consider possible barriers when making a direct comparison between different nations, cultures and times. [ABSTRACT FROM AUTHOR]

Background: Data for health surveys are often collected using either mailed questionnaires, telephone interviews or a combination. Mode of data collection can affect the propensity to refuse to respond and result in different patterns of responses. The objective of this paper is to examine and quantify effects of mode of data collection in health surveys. Methods: A stratified sample of 4,000 adults residing in Denmark was randomised to mailed questionnaires or computer-assisted telephone interviews. 45 health-related items were analyzed; four concerning behaviour and 41 concerning self assessment. Odds ratios for more positive answers and more frequent use of extreme response categories (both positive and negative) among telephone respondents compared to questionnaire respondents were estimated. Tests were Bonferroni corrected. Results: For the four health behaviour items there were no significant differences in the response patterns. For 32 of the 41 health self assessment items the response pattern was statistically significantly different and extreme response categories were used more frequently among telephone respondents (Median estimated odds ratio: 1.67). For a majority of these mode sensitive items (26/32), a more positive reporting was observed among telephone respondents (Median estimated odds ratio: 1.73). The overall response rate was similar among persons randomly assigned to questionnaires (58.1%) and to telephone interviews (56.2%). A differential nonresponse bias for age and gender was observed. The rate of missing responses was higher for questionnaires (0.73 - 6.00%) than for telephone interviews (0 - 0.51%). The "don't know" option was used more often by mail respondents (10 - 24%) than by telephone respondents (2 - 4%). Conclusion: The mode of data collection affects the reporting of self assessed health items substantially. In epidemiological studies, the method effect may be as large as the effects under investigation. Caution is needed when comparing prevalences across surveys or when studying time trends. [ABSTRACT FROM AUTHOR]

Background: The effects of postal questionnaire burden on return rates and answers given are unclear following treatment on an intensive care unit (ICU). We aimed to establish the effects of different postal questionnaire burdens on return rates and answers given.Methods: Design: A parallel group randomised controlled trial. We assigned patients by computer-based randomisation to one of two questionnaire packs (Group A and Group B).Setting: Patients from 26 ICUs in the United Kingdom.Inclusion Criteria: Patients who had received at least 24 h of level 3 care and were 16 years of age or older. Patients did not know that there were different questionnaire burdens. The study included 18,490 patients. 12,170 were eligible to be sent a questionnaire pack at 3 months. We sent 12,105 questionnaires (6112 to group A and 5993 to group B).Interventions: The Group A pack contained demographic and EuroQol group 5 Dimensions 3 level (EQ-5D-3 L) questionnaires, making four questionnaire pages. The Group B pack also contained the Hospital Anxiety and Depression Score (HADS) and the Post-Traumatic Stress Disorder Check List-Civilian (PCL-C) questionnaires, making eight questionnaire pages in total.Main Outcome Measure: Questionnaire return rate 3 months after ICU discharge by group.Results: In group A, 2466/6112 (40.3%) participants responded at 3 months. In group B 2315/ 5993 (38.6%) participants responded (difference 1.7% CI for difference 0-3.5% p = 0.053). Group A reported better functionality than group B in the EQ-5D-3 L mobility (41% versus 37% reporting no problems p = 0.003) and anxiety/depression (59% versus 55% reporting no problems p = 0.017) domains.Conclusions: In survivors of intensive care, questionnaire burden had no effect on return rates. However, questionnaire burden affected answers to the same questionnaire (EQ-5D-3 L).Trial Registration: ISRCTN69112866 (assigned 02/05/2006). [ABSTRACT FROM AUTHOR]

Background: Reliable information on the use of health services is important for health care planning, monitoring and policy. It is critical to assess the validity of the sources used for this purpose, including register and survey-based data. Studies on foreign-born populations' health care use have usually implemented either survey or register data. The concordance of such data among groups of different cultural background remains largely unknown. In this study, we presented an approach to examine routinely how survey and register-related characteristics may explain disagreement found between the two information sources.Methods: We linked register- and survey-based data pertaining to the Finnish Register of Primary Health Care general physician visits and the Survey on Well-Being among Foreign Born Population (FinMonik, 2018-2019), a nationally representative survey. The sample comprised n = 5,800 informants for whom registered general physician visits were tracked in the 12-month period preceding their participation in the survey. Cohen's kappa was used as measure of multisource concordance, hierarchical loglinear models for the association between single predictors and multisource discrepancy, and a logistic regression model for examining source-related predictors of source discrepancy. Survey weights were used in all sample analyses.Results: Source concordance was poor. When dichotomizing general physician visits (zero vs one or more), 35% of informants had reported one or more visits while none were found from register. Both register- and informant-related predictors were associated to this discrepancy (i.e. catchment area, private health care use, inability to work, region of origin and reason for migration).Conclusions: We found high discrepancy between the reported and the registered physician visits among the foreign-born population in Finland, with a particularly high number of reported physician visits when none were found in the register. There was a strong association between the specific catchment area and mismatch, indicating that both register under-coverage and survey over-report are plausible and may coexist behind the discrepancy. However, associations of informant's characteristics and mismatch were less pronounced. Implications on the validity of medical information sources are discussed. [ABSTRACT FROM AUTHOR]

Background: Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions. As a means to assess the potential utility of group sequential designs, we re-analyse data from a number of recent high-profile RCTs and assess whether using such a design would have caused the trial to stop early.Methods: Many pragmatic RCTs monitor participants at a number of occasions (e.g. at 6, 12 and 24 months after surgery) during follow-up as a means to assess recovery and also to keep participants engaged with the trial process. Conventionally one of the outcomes is selected as the primary (final) outcome, for clinical reasons, with others designated as either early or late outcomes. In such settings, novel group sequential designs that use data from not only the final outcome but also from early outcomes at interim analyses can be used to inform stopping decisions. We describe data from seven recent surgical RCTs (WAT, DRAFFT, WOLLF, FASHION, CSAW, FIXDT, TOPKAT), and outline possible group sequential designs that could plausibly have been proposed at the design stage. We then simulate how these group sequential designs could have proceeded, by using the observed data and dates to replicate how information could have accumulated and decisions been made for each RCT.Results: The results of the simulated group sequential designs showed that for two of the RCTs it was highly likely that they would have stopped for futility at interim analyses, potentially saving considerable time (15 and 23 months) and costs and avoiding patients being exposed to interventions that were either ineffective or no better than standard care. We discuss the characteristics of RCTs that are important in order to use the methodology we describe, particularly the value of early outcomes and the window of opportunity when early stopping decisions can be made and how it is related to the length of recruitment period and follow-up.Conclusions: The results for five of the RCTs tested showed that group sequential designs using early outcome data would have been feasible and likely to provide designs that were at least as efficient, and possibly more efficient, than the original fixed sample size designs. In general, the amount of information provided by the early outcomes was surprisingly large, due to the strength of correlations with the primary outcome. This suggests that the methods described here are likely to provide benefits more generally across the range of surgical trials and more widely in other application areas where trial designs, outcomes and follow-up patterns are structured and behave similarly. [ABSTRACT FROM AUTHOR]

Background: Postal self-completion questionnaires offer one of the least expensive modes of collecting patient based outcomes in health care research. The purpose of this review is to assess the efficacy of methods of increasing response to postal questionnaires in health care studies on patient populations. Methods: The following databases were searched: Medline, Embase, CENTRAL, CDSR, PsycINFO, NRR and ZETOC. Reference lists of relevant reviews and relevant journals were hand searched. Inclusion criteria were randomised trials of strategies to improve questionnaire response in health care research on patient populations. Response rate was defined as the percentage of questionnaires returned after all follow-up efforts. Study quality was assessed by two independent reviewers. The Mantel-Haenszel method was used to calculate the pooled odds ratios. Results: Thirteen studies reporting fifteen trials were included. Implementation of reminder letters and telephone contact had the most significant effect on response rates (odds ratio 3.7, 95% confidence interval 2.30 to 5.97 p = <0.00001). Shorter questionnaires also improved response rates to a lesser degree (odds ratio 1.4, 95% confidence interval 1.19 to 1.54). No evidence was found that incentives, re-ordering of questions or including an information brochure with the questionnaire confer any additional advantage. Conclusion: Implementing repeat mailing strategies and/or telephone reminders may improve response to postal questionnaires in health care research. Making the questionnaire shorter may also improve response rates. There is a lack of evidence to suggest that incentives are useful. In the context of health care research all strategies to improve response to postal questionnaires require further evaluation. [ABSTRACT FROM AUTHOR]

Background: The habitual "any other comments" general open question at the end of structured questionnaires has the potential to increase response rates, elaborate responses to closed questions, and allow respondents to identify new issues not captured in the closed questions. However, we believe that many researchers have collected such data and failed to analyse or present it. Discussion: General open questions at the end of structured questionnaires can present a problem because of their uncomfortable status of being strictly neither qualitative nor quantitative data, the consequent lack of clarity around how to analyse and report them, and the time and expertise needed to do so. We suggest that the value of these questions can be optimised if researchers start with a clear understanding of the type of data they wish to generate from such a question, and employ an appropriate strategy when designing the study. The intention can be to generate depth data or 'stories' from purposively defined groups of respondents for qualitative analysis, or to produce quantifiable data, representative of the population sampled, as a 'safety net' to identify issues which might complement the closed questions. Summary: We encourage researchers to consider developing a more strategic use of general open questions at the end of structured questionnaires. This may optimise the quality of the data and the analysis, reduce dilemmas regarding whether and how to analyse such data, and result in a more ethical approach to making best use of the data which respondents kindly provide. [ABSTRACT FROM AUTHOR]

Background: Questionnaires remain one of the most common forms of data collection in epidemiology, psychology and other human-sciences. However, results can be badly affected by non-response. One way to potentially reduce non-response is by sending potential study participants advance communication. The last systematic review to examine the effect of questionnaire pre-notification on response is 10 years old, and lacked a risk of bias assessment.Objectives: Update the section of the Cochrane systematic review, Edwards et al. (2009), on pre-notification to include 1) recently published studies, 2) an assessment of risk of bias, 3) Explore if heterogeneity is reduced by: delay between pre-contact and questionnaire delivery, the method of pre-contact, if pre-contact and questionnaire delivery differ, if the pre-contact includes a foot-in-the-door manipulation, and study's the risk of bias.Methods: Inclusion criteria: population: any population, intervention: comparison of some type of pre-notification, comparison group: no pre-notification, outcome: response rates.Study Design: randomised controlled trails.Exclusion Criteria: NA.Data Sources: Studies which cited or were included in Edwards et al. (2009); We additionally searched: CINAHL, Web of Science, PsycInfo, MEDLINE, EconLit, EMBASE, Cochrane Central, Cochrane CMR, ERIC, and Sociological Abstracts. The searches were implemented in June 2018 and May 2021. Study screening: a single reviewer screened studies, with a random 10% sample independently screened to ascertain accuracy.Data Extraction: data was extracted by a single reviewer twice, with a week between each extraction. Risk of Bias: within studies bias was assessed using the Cochrane Risk of Bias tool (ROB1) by a single unblinded reviewer, across studies bias was assessed using funnel plots. Synthesis Method: study results were meta-analysed with a random effects model using the final response rate as the outcome. Evaluation of Uncertainty: Uncertainty was evaluated using the GRADE approach.Results: One hundred seven trials were included with 211,802 participants. Over-all pre-notification increased response, OR = 1.33 (95% CI: 1.20-1.47). However, there was a large amount of heterogeneity (I2 = 97.1%), which was not explained by the subgroup analyses. In addition, when studies at high or unclear risk of bias were excluded the effect was to reduced OR = 1.09 (95% CI: 0.99-1.20). Because of the large amount of heterogeneity, even after restricting to low risk of bias studies, there is still moderate uncertainty in these results.Conclusions: Using the GRADE evaluation, this review finds moderate evidence that pre-notification may not have an effect on response rates.Funding: Economic and Social Research Council.Preregistration: None. [ABSTRACT FROM AUTHOR]

Background: The Oslo Sport Trauma Research Centre Questionnaire on Health Problems (OSTRC-H) has become a popular tool to monitor health status in athletes. Originally developed for adult athletes, the tool is today also being used in adolescent athletes. However, little is known on the suitability of the questionnaire for the adolescent age group and the methodological implications of applying the tool to prospectively monitor illness and injury. To address this gap in methodological knowledge, the aim of this study is to outline and discuss the adaption and application process of the OSTRC-H to adolescent football players.Method: The adaption process included a slightly modified back-translation method to translate the questionnaire. The application process included a web-based version of the Swedish OSTRC-H sent out once a week over 23 weeks to 115 adolescent football players aged 10-19 attending two football schools in Sweden. The response rate and prevalence of health problems over 23 weeks were calculated as feasibility indicators. Additionally, comprehensibility questions were added to the questionnaire in the end of the study.Result: No major disagreement was found between the original and translated versions of the questionnaire. However, significant changes to the wording of the questions and answer categories were necessary to adapt it to adolescents. A visual body figure was also added. The average weekly response rate was 38% (SD 13.5). To increase this rate, questionnaire data was gathered retrospectively through telephone and email contact with the participants and their parents, elevating the response rate to 53% (SD 15.5). The adolescents experienced the questionnaire as easy to understand and to cover all relevant health problems.Conclusion: Our study demonstrates the importance of adapting the questionnaire to the adolescent target group through translation, pre-tests, adjustments of wording and the facilitation of answering the questionnaire using a visual body figure. The study further shows the importance of keeping close and personal contact with the participants, their parents, teachers, and coaches throughout data collection. Future studies should take into account the age group and study context when adapting and applying the OSTRC-H to adolescents. [ABSTRACT FROM AUTHOR]

Background: Patient satisfaction or experience with colorectal cancer screening can determine adherence to screening programs. An evaluation of validated patient reported outcome measures (PROMs) for measuring experience or satisfaction with colorectal cancer screening does not exist. Our objective was to identify and critically appraise validated questionnaires for measuring patient satisfaction or experience with colorectal cancer screening.Methods: We conducted a systematic review following the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. We conducted searches on MEDLINE, EMBASE, PsychINFO, CINAHL and BiblioPRO and assessed the methodological quality of studies and measurement properties of questionnaires according to the COSMIN guidelines for systematic reviews of PROMs. PROSPERO registration number: CRD42019118527.Results: We included 80 studies that used 75 questionnaires, of which only 5 were validated. Four questionnaires measured satisfaction with endoscopy: two in the context of colorectal cancer screening (for colonoscopy and sigmoidoscopy) and two for non-screening endoscopy. One questionnaire measured satisfaction with bowel preparation. The methodological quality of studies was variable. The questionnaires with evidence for sufficient content validity and internal consistency were: the CSSQP questionnaire, which measures safety and satisfaction with screening colonoscopy, and the Post-Procedure questionnaire which measures satisfaction with non-screening endoscopic procedures.Conclusions: This systematic review shows that a minority of existing PROMs for measuring patient satisfaction with colorectal cancer screening are validated. We identified two questionnaires with high potential for further use (CSSQP and the Post-Procedure questionnaire). [ABSTRACT FROM AUTHOR]

Abstract In composing multi-thematic questionnaires for the Lolland-Falster Health Study (LOFUS), we faced a range of challenges, for which we found limited guidance in the literature. LOFUS is a household-based population study covering multiple medical and social research areas and targeting the mixed rural-provincial population of 103,000 persons on the Danish islands Lolland and Falster. Households were randomly selected for invitation. In this paper, we describe and discuss challenges in developing the questionnaires related to stakeholders, content of the questionnaire, and the process itself. The development process was characterised by loops of learning and can be described as an iterative and incremental process. We propose recommendations to researchers and administrators involved in similar development processes, including awareness of the non-linearity and complexity of the process, a need for negotiations and navigation among multiple stakeholders, and acknowledgement of pragmatism as an inherent part of decisions made in the process.

Background: Acute Care Surgery (ACS) was developed as a structured, team-based approach to providing round-the-clock emergency general surgery (EGS) care for adult patients needing treatment for diseases such as cholecystitis, gastrointestinal perforation, and necrotizing fasciitis. Lacking any prior evidence on optimizing outcomes for EGS patients, current implementation of ACS models has been idiosyncratic. We sought to use a Donabedian approach to elucidate potential EGS structures and processes that might be associated with improved outcomes as an initial step in designing the optimal model of ACS care for EGS patients.Methods: We developed and implemented a national survey of hospital-level EGS structures and processes by surveying surgeons or chief medical officers regarding hospital-level structures and processes that directly or indirectly impacted EGS care delivery in 2015. These responses were then anonymously linked to 2015 data from the American Hospital Association (AHA) annual survey, Medicare Provider Analysis and Review claims (MedPAR), 17 State Inpatient Databases (SIDs) using AHA unique identifiers (AHAID). This allowed us to combine hospital-level data, as reported in our survey or to the AHA, to patient-level data in an effort to further examine the role of EGS structures and processes on EGS outcomes. We describe the multi-step, iterative process utilizing the Donabedian framework for quality measurement that serves as a foundation for later work in this project.Results: Hospitals that responded to the survey were primarily non-governmental and located in urban settings. A plurality of respondent hospitals had fewer than 100 inpatient beds. A minority of the hospitals had medical school affiliations.Discussion: Our results will enable us to develop a measure of preparedness for delivering EGS care in the US, provide guidance for regionalized care models for EGS care, tiering of ACS programs based on the robustness of their EGS structures and processes and the quality of their outcomes, and formulate triage guidelines based on patient risk factors and severity of EGS disease.Conclusions: Our work provides a template for team science applicable to research efforts combining primary data collection (i.e., that derived from our survey) with existing national data sources (i.e., SIDs and MedPAR). [ABSTRACT FROM AUTHOR]

Abstract Background Missing data can introduce bias in the results of randomised controlled trials (RCTs), but are typically unavoidable in pragmatic clinical research, especially when patient reported outcome measures (PROMs) are used. Traditionally applied to the composite PROMs score of multi-item instruments, some recent research suggests that multiple imputation (MI) at the item level may be preferable under certain scenarios. This paper presents practical guidance on the choice of MI models for handling missing PROMs data based on the characteristics of the trial dataset. The comparative performance of complete cases analysis, which is commonly used in the analysis of RCTs, is also considered. Methods Realistic missing at random data were simulated using follow-up data from an RCT considering three different PROMs (Oxford Knee Score (OKS), EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L), 12-item Short Form Survey (SF-12)). Data were multiply imputed at the item (using ordinal logit and predicted mean matching models), sub-scale and score level; unadjusted mean outcomes, as well as treatment effects from linear regression models were obtained for 1000 simulations. Performance was assessed by root mean square errors (RMSE) and mean absolute errors (MAE). Results Convergence problems were observed for MI at the item level. Performance generally improved with increasing sample sizes and lower percentages of missing data. Imputation at the score and subscale level outperformed imputation at the item level in small sample sizes (n ≤ 200). Imputation at the item level is more accurate for high proportions of item-nonresponse. All methods provided similar results for large sample sizes (≥500) in this particular case study. Conclusions Many factors, including the prevalence of missing data in the study, sample size, the number of items within the PROM and numbers of levels within the individual items, and planned analyses need consideration when choosing an imputation model for missing PROMs data.

Background: High response rates are essential when questionnaires are used within research, as representativeness can affect the validity of studies and the ability to generalise the findings to a wider population. The study aimed to measure the response rate to questionnaires from a large longitudinal epidemiological study and sought to determine if any changes made throughout data collection had a positive impact on the response to questionnaires and addressed any imbalance in response rates by participants' levels of deprivation.Methods: Data were taken from a prospective, comparative study, designed to examine the effects of the reintroduction of water fluoridation on children's oral health over a five-year period. Response rates were analysed for the first year of data collection. During this year changes were made to the questionnaire layout and cover letter to attempt to increase response rates. Additionally a nested randomised control trial compared the effect on response rates of three different reminders to complete questionnaires.Results: Data were available for 1824 individuals. Sending the complete questionnaire again to non-responders resulted in the highest level of response (25%). A telephone call to participants was the only method that appeared to address the imbalance in deprivation, with a mean difference in deprivation score of 2.65 (95% CI -15.50 to 10.20) between the responders and non-responders.Conclusions: Initially, low response rates were recorded within this large, longitudinal study giving rise to concerns about non-response bias. Resending the entire questionnaire again was the most effective way of reminding participants to complete the questionnaire. As this is a less labour intensive method than for example, calling participants, more time can then be spent targeting groups who are underrepresented. In order to address these biases, data can be weighted in order to draw conclusions about the population. [ABSTRACT FROM AUTHOR]

Background: Person-environment fit, which examines the individual's perceptions of if, and in what way, he or she is compatible with aspects of the work context, offers a promising conceptual model for understanding employees and their interactions in health care environments. There are numerous potential ways an individual feels they "fit" with their environment. The construct was first noted almost thirty years ago, yet still remains elusive. Feelings of fit with one's environment are typically measured by surveys, but current surveys encompass only a subset of the different components of fit, which may limit the conclusions drawn. Further, these surveys have rarely been conducted in a focused way in health care settings.Method: This article describes the development of a multidimensional survey tool to measure fit in relation to the person's work group (termed person-group (P-G) fit) and their organisation (person-organisation (P-O) fit). The participants were mental health care employees, volunteers, and university interns (n = 213 for P-O fit; n = 194 for P-G fit). Confirmatory Factor Analyses (CFAs) were conducted using LISREL.Results: Valid and reliable sub-scales were found.Conclusion: This advanced multidimensional survey tool can be used to measure P-O and P-G fit, and illuminates new information about the theoretical structure of the fit construct. [ABSTRACT FROM AUTHOR]

Background: Achieving adequate response rates is an ongoing challenge for longitudinal studies. The World Trade Center Health Registry is a longitudinal health study that periodically surveys a cohort of ~71,000 people exposed to the 9/11 terrorist attacks in New York City. Since Wave 1, the Registry has conducted three follow-up surveys (Waves 2-4) every 3-4 years and utilized various strategies to increase survey participation. A promised monetary incentive was offered for the first time to survey non-respondents in the recent Wave 4 survey, conducted 13-14 years after 9/11.Methods: We evaluated the effectiveness of a monetary incentive in improving the response rate five months after survey launch, and assessed whether or not response completeness was compromised due to incentive use. The study compared the likelihood of returning a survey for those who received an incentive offer to those who did not, using logistic regression models. Among those who returned surveys, we also examined whether those receiving an incentive notification had higher rate of response completeness than those who did not, using negative binomial regression models and logistic regression models.Results: We found that a $10 monetary incentive offer was effective in increasing Wave 4 response rates. Specifically, the $10 incentive offer was useful in encouraging initially reluctant participants to respond to the survey. The likelihood of returning a survey increased by 30% for those who received an incentive offer (AOR = 1.3, 95% CI: 1.1, 1.4), and the incentive increased the number of returned surveys by 18%. Moreover, our results did not reveal any significant differences on response completeness between those who received an incentive offer and those who did not.Conclusions: In the face of the growing challenge of maintaining a high response rate for the World Trade Center Health Registry follow-up surveys, this study showed the value of offering a monetary incentive as an additional refusal conversion strategy. Our findings also suggest that an incentive offer could be particularly useful near the end of data collection period when an immediate boost in response rate is needed. [ABSTRACT FROM AUTHOR]

Background: Sample selection can substantially affect the solutions generated using exploratory factor analysis. Validation studies of the 12-item World Health Organization (WHO) Disability Assessment Schedule 2.0 (WHODAS 2.0) have generally involved samples in which substantial proportions of people had no, or minimal, disability. With the WHODAS 2.0 oriented towards measuring disability across six life domains (cognition, mobility, self-care, getting along, life activities, and participation in society), performing factor analysis with samples of people with disability may be more appropriate. We determined the influence of the sampling strategy on (a) the number of factors extracted and (b) the factor structure of the WHODAS 2.0.Methods: Using data from adults aged 50+ from the six countries in Wave 1 of the WHO's longitudinal Study on global AGEing and adult health (SAGE), we repeatedly selected samples (n = 750) using two strategies: (1) simple random sampling that reproduced nationally representative distributions of WHODAS 2.0 summary scores for each country (i.e., positively skewed distributions with many zero scores indicating the absence of disability), and (2) stratified random sampling with weights designed to obtain approximately symmetric distributions of summary scores for each country (i.e. predominantly including people with varying degrees of disability).Results: Samples with skewed distributions typically produced one-factor solutions, except for the two countries with the lowest percentages of zero scores, in which the majority of samples produced two factors. Samples with approximately symmetric distributions, generally produced two- or three-factor solutions. In the two-factor solutions, the getting along domain items loaded on one factor (commonly with a cognition domain item), with remaining items loading on a second factor. In the three-factor solutions, the getting along and self-care domain items loaded separately on two factors and three other domains (mobility, life activities, and participation in society) on the third factor; the cognition domain items did not load together on any factor.Conclusions: High percentages of participants with no disability (i.e., zero scores) produce heavily censored data (i.e., floor effects), limiting data heterogeneity and reducing the numbers of factors retained. The WHODAS 2.0 appears to have multiple closely-related factors. Samples of convenience and those collected for other purposes (e.g., general population surveys) would usually be inadequate for validating measures using exploratory factor analysis. [ABSTRACT FROM AUTHOR]

Background: Within epidemiological and clinical research, missing data are a common issue and often over looked in publications. When the issue of missing observations is addressed it is usually assumed that the missing data are 'missing at random' (MAR). This assumption should be checked for plausibility, however it is untestable, thus inferences should be assessed for robustness to departures from missing at random.Methods: We highlight the method of pattern mixture sensitivity analysis after multiple imputation using colorectal cancer data as an example. We focus on the Dukes' stage variable which has the highest proportion of missing observations. First, we find the probability of being in each Dukes' stage given the MAR imputed dataset. We use these probabilities in a questionnaire to elicit prior beliefs from experts on what they believe the probability would be in the missing data. The questionnaire responses are then used in a Dirichlet draw to create a Bayesian 'missing not at random' (MNAR) prior to impute the missing observations. The model of interest is applied and inferences are compared to those from the MAR imputed data.Results: The inferences were largely insensitive to departure from MAR. Inferences under MNAR suggested a smaller association between Dukes' stage and death, though the association remained positive and with similarly low p values.Conclusions: We conclude by discussing the positives and negatives of our method and highlight the importance of making people aware of the need to test the MAR assumption. [ABSTRACT FROM AUTHOR]

Background: Data on health-related quality of life (HRQoL) is paramount for shared and evidence based decision-making. Since an overview of cervical cancer HRQoL tools and their validity appears to be lacking, we performed a systematic review on usage of disease specific HRQoL instruments in cervical cancer patients and their psychometric properties to identify the most suitable cervical cancer specific HRQoL tool.Methods: We searched Pubmed, EMBASE and PsycINFO from inception up to 18 October 2016 for studies on quality of life in cervical cancer patients. Data extraction and HRQoL identification was performed by two independent reviewers. Validation studies of the identified cervical cancer specific HRQoL tools were retrieved and assessed on psychometric properties using the COSMIN checklist. All used cervical cancer specific HRQoL instruments were scored and ranked according to their psychometric properties.Results: We included 156 studies (20,690 patients) and identified 31 HRQoL tools. The EORTC QLQ-CX24 (35 studies; 5,556 patients) and FACT-Cx (22 studies; 4,224 patients) were the only cervical cancer specific tools. The EORTC QLQ-CX24 had 4 out of 9 positive rated psychometric properties; internal consistency, content and construct validity, and agreement. Criterion validity, reliability, and interpretability scored doubtful. Responsiveness and floor- and ceiling effects were not reported. The FACT-Cx had 2 out of 9 positive rated psychometric properties; internal consistency and agreement. Content validity, reliability, and interpretability scored doubtful while criterion and construct validity scored negative. Responsiveness and floor- and ceiling effects were not reported.Conclusion: The validity of the often used EORTC QLQ-CX24 questionnaire for cervical cancer patients remains uncertain as 5 out of 9 psychometric properties were doubtful or not reported in current literature. Cervical cancer specific HRQoL tools should therefore always be used in conjunction with validated generic cancer HRQoL tools until proper validity has been proven, or a more valid tool has been developed. [ABSTRACT FROM AUTHOR]

Background: Generic quality of life (QoL) instruments provide important measures of self-reported wellbeing that can be compared across healthy and clinical populations. The aim of this analysis is to validate the ten-item QoL instrument "QOL10", as well as to confirm the validity of the embedded "QOL5" questionnaire and single-item "QOL1" in measuring overall QoL among adults in a substance use disorder treatment study.Methods: We used exploratory factor analysis and measured internal and convergent validity of the QOL10 against the gold standard measure of the WHOQOL-BREF, in a subsample of 107 participants in a substance use disorder treatment study.Results: The QOL10 displayed internal and convergent validity to the gold standard measure. Factor analysis revealed a two-factor structure that can be interpreted as "social QoL", containing items about relationships and social functioning, and "global QoL", comprised of items about health, working ability, self-evaluation, and an overall QoL estimation.Conclusions: The QOL10 provides clinically useful and valid measures of social-related QoL and global QoL via two subscales. Interestingly, the QOL10's social QoL measure, from the current sample, had little relationship to the analyzed groups previously reported to have differential global QoL: social QoL appears to be not only conceptually distinct from global QoL, but also to be less influenced by typical substance- and treatment-specific factors. [ABSTRACT FROM AUTHOR]

Background: Research has shown inconsistencies in results and difficulties in conceptualization of assessment of socioeconomic status (SES) among adolescents. The aim of this study was thus to test the validity of self-reported information on SES in two age-groups (11-13 and 14-16 years old) in an adolescent population and to evaluate its relationship to self-reported health related quality of life (HRQOL). Different measures of SES commonly used in research in relation to HRQOL were tested in this study; parent's occupations status, family material affluence status (FAS) and perceived SES.Method: A cross-sectional study, with a sample of 948 respondents (n = 467, 11-13 years old and n = 481, 14-16 years old) completed questionnaires about SES and HRQOL. The adolescents' completion rates were used, with chi2-test, to investigate differences between gender and age-group. Correlation was used for convergent validity and ANOVA for concurrent validity.Results: We found a low completion rate for both fathers' (41.7 %) and mothers' (37.5 %) occupation status, and a difference in completion rate between gender and age-groups. FAS had the highest completion rate (100 %) compared to parent's occupations status and perceived SES. The convergent validity between the SES-indicators was weak (Spearman correlation coefficient below 0.3), suggesting that the indicators measured different dimensions of SES. Both FAS and perceived SES showed a gradient in mean HRQOL between low and high SES in relation to HRQOL, this was significant only for perceived SES (p < 0.01, both age-groups).Conclusion: This study indicates the need for considering different approaches to measures of SES among adolescences and when evaluating SES in relation to HRQOL. Further research is needed to investigate sustainable ways to measure SES, delineating the relevance of tangible measures of education, occupation and income in relation to the perceived socioeconomic status in comparison with others in immediate social networks and in society at large. [ABSTRACT FROM AUTHOR]

Background: Multi-item questionnaires are important instruments for monitoring health in epidemiological longitudinal studies. Mostly sum-scores are used as a summary measure for these multi-item questionnaires. The objective of this study was to show the negative impact of using sum-score based longitudinal data analysis instead of Item Response Theory (IRT)-based plausible values. Methods: In a simulation study (varying the number of items, sample size, and distribution of the outcomes) the parameter estimates resulting from both modeling techniques were compared to the true values. Next, the models were applied to an example dataset from the Amsterdam Growth and Health Longitudinal Study (AGHLS). Results: The results show that using sum-scores leads to overestimation of the within person (repeated measurement) variance and underestimation of the between person variance. Conclusions: We recommend using IRT-based plausible value techniques for analyzing repeatedly measured multi-item questionnaire data. [ABSTRACT FROM AUTHOR]

Background: Low participation rates reduce effective sample size, statistical power and can increase risk for selection bias. Previous research suggests that offering choice of participation mode can improve participation rates. However, few head-to-head trials compared choice of participation mode using telephone interviews and postal questionnaires as modes of interest. Aiming to explore effects of choice of participation, two randomized controlled trials were performed comparing participation rates of patients provided with and without choice of participation mode, using interviews and questionnaires as participation modes. Methods: Two trials were embedded in a larger study on cardiovascular risk management in primary care. Patients with a chronic cardiovascular condition recruited for the larger study were invited to participate in an additional survey on social networks, using invitations with and without choice of participation mode. Primary outcome was participation rate. Other outcomes of interest were participation rate conditional on willingness to participate, and initial willingness to participate. In trial 1 we compared outcomes after choice of participation mode (interview or questionnaire) with invitations for participation in a telephone interview. In Trial 2 results for choice of participation mode were compared with postal questionnaires. Results: In Trial 1 no differences were found in participation rates (65% vs 66%, p = 0.853) although conditional participation rate was highest for interviews (90% vs 72%, p < .01). Initial willingness to participate was higher when choice of participation mode was provided (90% versus 73%, p < .01). In Trial 2 participation rate and conditional participation rate was higher when choice of participation mode was provided (59% vs 46%, p < .01 and 66% vs 53%, p < .01, respectively). No differences were found for initial willingness to participate (90% vs 86%, p = 0.146). Conclusion: Offering choice of participation mode had benefit on participation rates compared to invitations to participate in questionnaires, but not when compared to invitations to participate in telephone interviews. Trial registration: Current Controlled Trials ISRCTN89237105. [ABSTRACT FROM AUTHOR]

Background Multiple imputation (MI) was developed as a method to enable valid inferences to be obtained in the presence of missing data rather than to re-create the missing values. Within the applied setting, it remains unclear how important it is that imputed values should be plausible for individual observations. One variable type for which MI may lead to implausible values is a limited-range variable, where imputed values may fall outside the observable range. The aim of this work was to compare methods for imputing limited-range variables, with a focus on those that restrict the range of the imputed values. Methods Using data from a study of adolescent health, we consider three variables based on responses to the General Health Questionnaire (GHQ), a tool for detecting minor psychiatric illness. These variables, based on different scoring methods for the GHQ, resulted in three continuous distributions with mild, moderate and severe positive skewness. In an otherwise complete dataset, we set 33% of the GHQ observations to missing completely at random or missing at random; repeating this process to create 1000 datasets with incomplete data for each scenario. For each dataset, we imputed values on the raw scale and following a zero-skewness log transformation using: univariate regression with no rounding; post-imputation rounding; truncated normal regression; and predictive mean matching. We estimated the marginal mean of the GHQ and the association between the GHQ and a fully observed binary outcome, comparing the results with complete data statistics. Results Imputation with no rounding performed well when applied to data on the raw scale. Postimputation rounding and imputation using truncated normal regression produced higher marginal means than the complete data estimate when data had a moderate or severe skew, and this was associated with under-coverage of the complete data estimate. Predictive mean matching also produced under-coverage of the complete data estimate. For the estimate of association, all methods produced similar estimates to the complete data. Conclusions For data with a limited range, multiple imputation using techniques that restrict the range of imputed values can result in biased estimates for the marginal mean when data are highly skewed. [ABSTRACT FROM AUTHOR]

Background: Health professionals' behaviour is a key component in compliance with evidence-based recommendations. Opinion leaders are an oft-used method of influencing such behaviours in implementation studies, but reliably and cost effectively identifying them is not straightforward. Survey and questionnaire based data collection methods have potential and carefully chosen items can - in theory - both aid identification of opinion leaders and help in the design of an implementation strategy itself. This study compares two methods of identifying opinion leaders for behaviour-change interventions. Methods: Healthcare professionals working in a single UK mental health NHS Foundation Trust were randomly allocated to one of two questionnaires. The first, slightly longer questionnaire, asked for multiple nominations of opinion leaders, with specific information about the nature of the relationship with each nominee. The second, shorter version, asked simply for a list of named "champions" but no more additional information. We compared, using Chi Square statistics, both the questionnaire response rates and the number of health professionals likely to be influenced by the opinion leaders (i.e. the "coverage" rates) for both questionnaire conditions. Results: Both questionnaire versions had low response rates: only 15% of health professionals named colleagues in the longer questionnaire and 13% in the shorter version. The opinion leaders identified by both methods had a low number of contacts (range of coverage, 2-6 each). There were no significant differences in response rates or coverage between the two identification methods. Conclusions: The low response and population coverage rates for both questionnaire versions suggest that alternative methods of identifying opinion leaders for implementation studies may be more effective. Future research should seek to identify and evaluate alternative, non-questionnaire based, methods of identifying opinion leaders in order to maximise their potential in organisational behaviour change interventions. [ABSTRACT FROM AUTHOR]

Background: Although in health services survey research we strive for a high response rate, this must be balanced against the need to recruit participants ethically and considerately, particularly in surveys with a sensitive nature. In survey research there are no established recommendations to guide recruitment approach and an 'opt-in' system that requires potential participants to request a copy of the questionnaire by returning a reply slip is frequently adopted. However, in observational research the risk to participants is lower than in clinical research and so some surveys have used an 'opt-out' system. The effect of this approach on response and distress is unknown. We sought to investigate this in a survey of end of life care completed by bereaved relatives. Methods: Out of a sample of 1422 bereaved relatives we assigned potential participants to one of two study groups: an 'opt in' group (n=711) where a letter of invitation was issued with a reply slip to request a copy of the questionnaire; or an 'opt out' group (n=711) where the survey questionnaire was provided alongside the invitation letter. We assessed response and distress between groups. Results: From a sample of 1422, 473 participants returned questionnaires. Response was higher in the 'opt out' group than in the 'opt in' group (40% compared to 26.4%: X2 =29.79, p-value<.01), there were no differences in distress or complaints about the survey between groups, and assignment to the 'opt out' group was an independent predictor of response (OR=1.84, 95% CI: 1.45-2.34). Moreover, the 'opt in' group were more likely to decline to participate (X2=28.60, p-value<.01) and there was a difference in the pattern of questionnaire responses between study groups. Conclusion: Given that the 'opt out' method of recruitment is associated with a higher response than the 'opt in' method, seems to have no impact on complaints or distress about the survey, and there are differences in the patterns of responses between groups, the 'opt out' method could be recommended as the most efficient way to recruit into surveys, even in those with a sensitive nature. [ABSTRACT FROM AUTHOR]

Background: Studies on the health benefits from breastfeeding often rely on maternal recall of breastfeeding. Although short-term maternal recall has been found to be quite accurate, less is known about long-term accuracy. The objective of this study was to assess the accuracy of long-term maternal recall of breastfeeding duration. Methods: In a prospective study of pregnancy and birth outcome, detailed information on breastfeeding during the child's first year of life was collected from a cohort of Norwegian women who gave birth in 1986-88. Among 374 of the participants, data on breastfeeding initiation and duration were compared to recalled data obtained from mailed questionnaires some 20 years later. Intraclass correlation coefficient (ICC), Bland-Altman plot, and Kappa statistics were used to assess the agreement between the two sources of data. Logistic regression was used to assess predictors of misreporting breastfeeding duration by more than one month. Results: Recorded and recalled breastfeeding duration were strongly correlated (ICC=0.82, p < 0.001). Nearly two thirds of women recalled their breastfeeding to within one month. Recall data showed a modest median overestimation of about 2 weeks. There were no apparent systematic discrepancies between the two sources of information, but recall error was predicted by the age when infants were introduced to another kind of milk. Across categories of breastfeeding, the overall weighted Kappa statistic showed an almost perfect agreement (κ = 0.85, 95% confidence interval [CI] 0.82 - 0.88). Conclusion: Breastfeeding duration was recalled quite accurately 20 years after mothers gave birth in a population where breastfeeding is common and its duration long. [ABSTRACT FROM AUTHOR]

Background: As part of our research programme into facilitating improved ways of communicating with patients, especially about more sensitive clinical issues, we have been investigating whether there are any non-verbal methods that might aid this process. One such approach is to ask patients to choose a color in response to a particular question, for instance about health or psychological status, and for this purpose we developed the Manchester Color Wheel (MCW). This instrument consists of positive, neutral and negative colors and its validation in normal adults and those with anxiety or depression showed that it is responsive to change and reproducible. It also has the capacity to identify a positive frame of mind. We concluded that it might be a particularly useful instrument in adolescents and therefore this study aimed to validate it in a secondary school. Methods: 620 pupils (aged 11-17 years, mean age 14.0 years, 298 (48.1%) males, 322 (51.9%) females) at Sale Grammar School in Greater Manchester were asked to relate their mood to a MCW color and also complete the Hospital Anxiety Depression (HAD) questionnaire. To give these pupils an experience in science, 197 were divided into four subgroups for an 'experiment' to ascertain whether, compared to controls, a change in mood color choice could be induced by participation in sport, music or art activities. Results: Although mood color and HAD depression score are unlikely to be measuring exactly the same psychological state, a negative mood color was chosen by 62.5% of HAD depressed compared to only 14.5% of HAD normal pupils (p < 0.001). In contrast, a positive mood color was chosen by 48.9% of normal and only 18.8% of depressed pupils (p < 0.001). In the 'experiment', compared to controls, all activities resulted in an increased choice of positive mood colors which reached significance for sport and music. Conclusion: This study confirms the potential utility of the MCW to rapidly and easily assess a variety of health issues in large populations, including adolescents. Some of our results should also be of interest to educationalists. [ABSTRACT FROM AUTHOR]

Background: Despite growing support for mixed methods approaches we still have little systematic knowledge about the consequences of combining surveys and focus groups. While the methodological aspects of questionnaire surveys have been researched extensively, the characteristics of focus group methodology are understudied. We suggest and discuss whether the focus group setting, as compared to questionnaire surveys, encourages participants to exaggerate views in a negative direction. Discussion: Based on an example from our own research, where we conducted a survey as a follow up of a focus group study, and with reference to theoretical approaches and empirical evidence from the literature concerning survey respondent behaviour and small group dynamics, we discuss the possibility that a discrepancy in findings between the focus groups and the questionnaire reflects characteristics of the two different research methods. In contrast to the survey, the focus group study indicated that doctors were generally negative to clinical guidelines. We were not convinced that this difference in results was due to methodological flaws in either of the studies, and discuss instead how this difference may have been the result of a general methodological phenomenon. Summary: Based on studies of how survey questionnaires influence responses, it appears reasonable to claim that surveys are more likely to find exaggerated positive views. Conversely, there are some indications in the literature that focus groups may result in complaints and overly negative attitudes, but this is still an open question. We suggest that while problematic issues tend to be under-communicated in questionnaire surveys, they may be overstated in focus groups. We argue for the importance of increasing our understanding of focus group methodology, for example by reporting interesting discrepancies in mixed methods studies. In addition, more experimental research on focus groups should be conducted to advance the methodology and to test our hypothesis. [ABSTRACT FROM AUTHOR]

Background: Accurate monitoring of health conditions and behaviours, and health service usage in the population, using an effective and economical method is important for planning and evaluation. This study examines the reliability of questions asked in a telephone survey by conducting a test/retest analysis of a range of questions covering demographic variables, health risk factors and self-reported chronic conditions among people aged 16 years and over. Methods: A Computer Assisted Telephone Interviewing (CATI) survey on health issues of South Australians was re-administered to a random sub-sample of 154 respondents between 13-35 days (mean 17) after the original survey. Reliability between questions was assessed using Cohen’s kappa and intraclass correlation coefficients. Results: Demographic questions (age, gender, number of adults and children in the household, country of birth) showed extremely high reliability (0.97 to 1.00). Health service use (ICC = 0.90 95% CI 0.86-0.93) and overall health status (Kappa = 0.60 95% CI 0.46-0.75) displayed moderate agreement. Questions relating to self-reported risk factors such as smoking (Kappa = 0.81 95% CI 0.72-0.89) and alcohol drinking (ICC 0.75 = 95% CI 0.63-0.83) behavior showed good to excellent agreement, while questions relating to self-reported risk factors such as time spent walking for physical activity (ICC 0.47 = 95% CI 0.27-0.61), fruit (Kappaw = 0.60 95% CI 0.45-0.76) and vegetable consumption (Kappaw = 0.50 95% CI 0.32-0.69) showed only moderate agreement. Self-reported chronic conditions displayed substantial to almost perfect agreement (0.72 to 1.00) with the exception of moderate agreement for heart disease (Kappa = 0.82 95% CI 0.57-0.99). Conclusion: These results show the questions assessed to be reliable in South Australia for estimating health conditions and monitoring health related behaviours using a CATI survey. [ABSTRACT FROM AUTHOR]

The article presents information on the Adolescent Resilience Questionnaire, a theoretically based, comprehensive multidimensional measure of resilience in adolescents. Extensive literature review were performed for the conceptual development of scales and items and it also included input from focus groups with young people living with chronic illness.

The article presents information on a study which tests some essential psychometric properties of the Low Vision Quality Of Life (LVQOL) questionnaire in an item response theory (IRT) model, along with evaluating differential item functioning (DIF). It used cross-sectional data from an observational study involving visually-impaired patients.