Development and Validation of an Artificial Intelligence-Assisted Patient Education Material for Ostomy Patients: A Methodological Study.

AIM: To develop and test the validity of an artificial intelligence-assisted patient education material for ostomy patients. DESIGN: A methodological study. METHODS: The study was carried out in two main stages and five steps: (1) determining the information needs of ostomy patients, (2) creating educational content, (3) converting the educational content into patient education material, (4) validation of patient education material based on expert review and (5) measuring the readability of the patient education material. We used ChatGPT 4.0 to determine the information needs and create patient education material content, and Publuu Online Flipbook Maker was used to convert the educational content into patient education material. Understandability and applicability scores were assessed using the Patient Education Materials Assessment Tool submitted to 10 expert reviews. The tool inter-rater reliability was determined via the intraclass correlation coefficient. Readability was analysed using the Flesch-Kincaid Grade Level, Gunning Fog Index and Simple Measure of Gobbledygook formula. RESULTS: The mean Patient Education Materials Assessment Tool understandability score of the patient education material was 81.91%, and the mean Patient Education Materials Assessment Tool actionability score was 85.33%. The scores for the readability indicators were calculated to be Flesch-Kincaid Grade Level: 8.53, Gunning Fog: 10.9 and Simple Measure of Gobbledygook: 7.99. CONCLUSIONS: The AI-assisted patient education material for ostomy patients provided accurate information with understandable and actionable responses to patients, but is at a high reading level for patients. IMPLICATIONS FOR THE PROFESSION AND PATIENT CARE: Artificial intelligence-assisted patient education materials can significantly increase patient information rates in the health system regarding ease of practice. Artificial intelligence is currently not an option for creating patient education material, and their impact on the patient is not fully known. REPORTING METHOD: The study followed the STROBE checklist guidelines. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contributions.

The Social Insurance Literacy Questionnaire (SILQ): Development and Psychometric Evaluation.

PURPOSE: For clients to understand social insurance decisions and processes, information from authorities needs to be comprehensible, and clients need sufficient individual abilities. These dimensions are captured by the concept social insurance literacy, which has been operationalized into a measure, the Social Insurance Literacy Questionnaire (SILQ). The aim of this study was to describe the development of the SILQ and evaluate its psychometric properties using Rasch measurement theory. METHODS: The development of the SILQ included a Delphi study and cognitive interviews. A preliminary version, divided on four scales corresponding to the domains of the concept (obtaining information, understanding information, acting on information, and system comprehensibility) was psychometrically evaluated according to Rasch measurement theory, in a survey to a stratified random sample of people on sick leave (n = 1151) sent out in the fall of 2020. RESULTS: Overall, the items in the final version of the SILQ demonstrated good fit to the Rasch model, and the response scale worked as intended. Unidimensionality was supported for all scales, but minor problems with local dependency was detected for three items. The person separation was 0.80 for the Obtain scale, 0.82 for the Understand scale, 0.68 for the Act scale, and 0.81 for the System scale. Corresponding ordinal alpha values were 0.91, 0.91, 0.86, and 0.91, respectively. CONCLUSION: This study is a first step toward exploring literacy in the social insurance field. The SILQ covers individual abilities and systems' comprehensibility, and the results show that it has acceptable psychometric properties.

Modification of the Public Attitude Towards Vaccination Scale for use in adult vaccines.

BACKGROUND: Vaccination is a crucial protective intervention to prevent adult mortality and morbidity. Personal perceptions and resources have an important place in the vaccination decision. AIM: This study aimed to modify the Public Attitude Towards Vaccination-Health Belief Model scale for adult vaccines and evaluate its psychometric properties. METHODS: Overall, 626 people participated in this methodological study. Content validity index, confirmatory factor analysis, internal consistency and item-total score correlation were used for validity and reliability. The independent samples t test, logistic regression analysis and ROC analysis were used for criterion and concurrent validity. RESULTS: In confirmatory factor analysis, values of fit indices were excellent or acceptable. The Cronbach alpha value was between 0.83 and 0.92. According to criterion validity, the susceptibility, severity, benefit, and health motivation scores of those with the vaccine were higher than those without, whereas their barrier score was lower. The barrier subscale was a risk factor, whereas the benefit score was a protective factor that increased the likelihood of vaccination. The concurrent validity of the scale was tested with the COVID-19 vaccine. While the barrier subscale's ability to distinguish between vaccinated (specificity) and unvaccinated (sensitivity) individuals is excellent, it is acceptable for the other subscales. CONCLUSION: Modified PAVS-HBM is valid and reliable for adult vaccines. This scale was associated with vaccination behaviour and distinguished between vaccinated and unvaccinated individuals.

Reporting of flow diagrams in randomised controlled trials published in periodontology and implantology: a survey.

BACKGROUND: Item 13 of the CONSORT guidelines recommends documentation of the participant flow in randomised clinical trials (RCTs) using a diagram. In the medical literature, the reporting of the flow of participants in RCTs has been assessed to be inadequate. The quality of reporting flow diagrams in periodontology and implantology remains unknown. The aim of this study was to assess the reporting of flow diagrams in RCTs published in periodontology and implantology journals. MATERIALS AND METHODS: RCTs published between 15th January 2018 and 15th January 2022 in twelve high-ranked periodontology and implantology journals were identified. Trial characteristics at the RCT level were extracted. The flow diagram included in each RCT was assessed for completeness of reporting in relation to published criteria and the CONSORT flow diagram template. RESULTS: From the 544 eligible articles, 85% were single-centre, 82% of parallel-group design and 79% investigated surgical interventions. Three-hundred and fifteen (58%) articles were published in CONSORT endorsing journals. A flow diagram was reported in 317 (58%) trials and reporting was more common in periodontology (73.1%). Overall, 56% of publications with a flow diagram reported a complete CONSORT flow diagram, while in 44% of flow diagrams, at least one point from the CONSORT reporting template was missing. Reasons for loss to follow-up (69.7%) and exclusions from the RCT analysis (86.4%) were poorly reported. CONCLUSION: The reporting of flow diagrams in periodontology and implantology RCTs was sub-optimal. Greater awareness of the importance of fully completing the participant CONSORT flow diagram is required.

Assessing IgE sensitization profiles to birch and timothy grass pollen allergens in birch pollen allergic blood donors using an oligoplex specific IgE assay.

IgE sensitization profiles to single birch allergens in birch-sensitized patients differ among European countries. The aim of this study was to determine the distribution of specific IgE antibodies to major and minor birch pollen allergens in a population of allergic Norwegian individuals by using a birch allergic blood donor population as a surrogate sample. Sixty blood donors were recruited and sampled based on birch allergy symptoms such as rhinitis, rhinoconjunctivitis and/or mild asthma in previous seasons. All sera were collected before start of the pollen season and tested using a line blot assay (Euroimmun AG, Lübeck, Germany) for IgE to birch and timothy pollen. Both extracts, single allergens, and cross-reacting carbohydrate determinants (CCD) were analysed. Only donors with specific IgE to birch and/or timothy grass were further evaluated. Specific IgE to birch pollen extract was found in 52 sera, and sensitization to timothy grass in 40 sera. Specific IgE to Bet v 1 was predominant in contrast to Bet v 4 which was absent. However, sensitization to the minor allergens Bet v 2 and 6 was always found together with high levels of IgE to Bet v 1. Subjects sensitized to the profilin Bet v 2 from birch were also sensitized to Phl p 12 from timothy grass. In conclusion, there was predominantly Bet v 1 sensitization in this cohort and low sensitization to minor allergens and cross-reactive allergens (Bet v 2, Bet v 4, Phl p 7 and Phl p 12).

Development and psychometric properties of the sleep problems and coping with sleep problem scales for pregnant women.

AIMS: The aim of this study is to develop a sleep problems scale and a coping with sleep problems scale for pregnant women and assess their reliability and validity. DESIGN: An empirical research quantitative design. REVIEW METHODS: Self-reported instruments were developed through (1) item generation, (2) preliminary item evaluation and (3) scale refining and evaluation. Item pools were created via literature review, opinions of experts and women with experience in pregnancy sleep. Content, construct and criterion validities were tested. Reliability was assessed using Cronbach's alpha, split-half reliability and corrected item-total correlation. DATA SOURCES: Data were collected between January 23 and July 22, 2020, at a hospital's obstetrics polyclinic. In the pilot and main study, 30 and 368 pregnant women (gestational age: 8-42 weeks) were included, respectively. RESULTS: The content validity index was >0.9 for each scale. Factor analysis showed 24 and 18 items in the two scales, both with four subdimensions. The corrected item-total correlations were acceptable, and Cronbach's alpha coefficient was 0.883 and 0.799, respectively. CONCLUSION: Both scales developed in this study are valid and reliable for the Turkish society. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE/GLOBAL CLINICAL COMMUNITY: This study's findings may prevent the lack of validated screening instruments to identify pregnancy-specific sleep features. IMPACT: We developed two scales to assess sleep problems in pregnant women. These were valid and reliable, can be routinely used by health professionals and may guide nurses and midwives in assessing and managing sleep problems during pregnancy. REPORTING METHOD: The study conforms to the COSMIN checklist. PATIENT OR PUBLIC CONTRIBUTION: Data were collected during face-to-face surveys. Ten women contributed to the item pool generation, 30 pregnant women participated in the pilot study, and 368 antenatal service users participated in the main study.

[Using the TRAPD method to translate the revised MISSCARE Survey from English into German: Revised MISSCARE-Austria]. / Übersetzung des revised MISSCARE Survey zum deutschsprachigen revised MISSCARE-Austria.

Using the TRAPD method to translate the revised MISSCARE Survey from English into German: Revised MISSCARE-Austria Abstract. Background: Questionnaire translations in German-speaking nursing science rely on methods using first- and back-translation techniques despite increasing criticism. In contrast, the TRAPD method is recognized as best practice in intercultural social research. However, experience with the application of this method in German-speaking nursing science is lacking. Aim: To describe the utilization of the TRAPD method using the example of the translation of the revised MISSCARE Survey from English into German and to discuss necessary adaptations, advantages, and limitations of this approach. Methods: An adapted version of the team-based translation method TRAPD was implemented through the steps: preparation, translation, review, adjudication, pretest, and documentation, based on the GESIS guidelines for intercultural questionnaire translation. Results: The new revised MISSCARE Austria instrument consists of 85 items. For the majority of the items, equivalent terms or phrases were found that allowed for a straightforward translation. For some items an adaptation was necessary due to cultural, measurement- and construct-related aspects. Translation equivalence regarding challenging items was examined with the first author and promoted by multiple cognitive pretesting with nurses. Conclusions: Our study strengthens the argument that the TRAPD method is appropriate for translating measurement instruments in German-speaking nursing science. However, this example shows that further experience with this method is necessary for its further development for our discipline.

Methodological assessment of systematic reviews of in-vitro dental studies.

BACKGROUND: Systematic reviews of in-vitro studies, like any other study, can be of heterogeneous quality. The present study aimed to evaluate the methodological quality of systematic reviews of in-vitro dental studies. METHODS: We searched for systematic reviews of in-vitro dental studies in PubMed, Web of Science, and Scopus databases published up to January 2022. We assessed the methodological quality of the systematic reviews using a modified "A MeaSurement Tool to Assess systematic Reviews" (AMSTAR-2) instrument. The 16 items, in the form of questions, were answered with yes, no, or py (partial yes). Univariable and multivariable linear regression models were used to examine the association between systematic review characteristics and AMSTAR-2 percent score. Overall confidence in the results of the systematic reviews was rated, based on weaknesses identified in critical and non-critical AMSTAR-2 items. RESULTS: The search retrieved 908 potential documents, and after following the eligibility criteria, 185 systematic reviews were included. The most researched topics were ceramics and dental bonding. The overall rating for the confidence in the results was critically low in 126 (68%) systematic reviews. There was high variability in the response among the AMSTAR-2 items (0% to 75% positively answered). The univariable analyses indicated dental specialty (p = 0.03), number of authors (coef: 1.87, 95% CI: 0.26, 3.47, p = 0.02), and year of publication (coef: 2.64, 95% CI: 1.90, 3.38, p < 0.01) were significantly associated with the AMSTAR-2 percent score. Whereas, in the multivariable analysis only specialty (p = 0.01) and year of publication (coef: 2.60, 95% CI: 1.84, 3.35, p < 0.001) remained significant. Among specialties, endodontics achieved the highest AMSTAR-2 percent score. CONCLUSIONS: The methods of systematic reviews of in vitro dental studies were suboptimal. Year of publication and dental specialty were associated with AMSTAR-2 scores. The overall rating of the confidence in the results was low and critically low for most systematic reviews.

Developing indicators of age-friendly neighbourhood environments for urban and rural communities across 20 low-, middle-, and high-income countries.

BACKGROUND: By 2050, the global population of adults 60 + will reach 2.1 billion, surging fastest in low- and middle-income countries (LMIC). In response, the World Health Organization (WHO) has developed indicators of age-friendly urban environments, but these criteria have been challenging to apply in rural areas and LMIC. This study fills this gap by adapting the WHO indicators to such settings and assessing variation in their availability by community-level urbanness and country-level income. METHODS: We used data from the Prospective Urban and Rural Epidemiology (PURE) study's environmental-assessment tools, which integrated systematic social observation and ecometrics to reliably capture community-level environmental features associated with cardiovascular-disease risk factors. The results of a scoping review guided selection of 18 individual indicators across six distinct domains, with data available for 496 communities in 20 countries, including 382 communities (77%) in LMIC. Finally, we used both factor analysis of mixed data (FAMD) and multitrait-multimethod (MTMM) approaches to describe relationships between indicators and domains, as well as detailing the extent to which these relationships held true within groups defined by urbanness and income. RESULTS: Together, the results of the FAMD and MTMM approaches indicated substantial variation in the relationship of individual indicators to each other and to broader domains, arguing against the development of an overall score and extending prior evidence demonstrating the need to adapt the WHO framework to the local context. Communities in high-income countries generally ranked higher across the set of indicators, but regular connections to neighbouring towns via bus (95%) and train access (76%) were most common in low-income countries. The greatest amount of variation by urbanness was seen in the number of streetscape-greenery elements (33 such elements in rural areas vs. 55 in urban), presence of traffic lights (18% vs. 67%), and home-internet availability (25% vs. 54%). CONCLUSIONS: This study indicates the extent to which environmental supports for healthy ageing may be less readily available to older adults residing in rural areas and LMIC and augments calls to tailor WHO's existing indicators to a broader range of communities in order to achieve a critical aspect of distributional equity in an ageing world.

Psychometric testing of the Determinants of Salt-Restriction Behaviour Questionnaire in people of Chinese ancestry: a methodological study.

PURPOSE: Nurses play a key role in educating people about a salt-reduced diet to prevent or manage hypertension or cardiac failure. Assessment tools such as the Chinese Determinants of Salt-Restriction Behaviour Questionnaire (DSRBQ) can provide essential evidence to inform education strategies. This study aimed to translate the DSRBQ into English and evaluate the psychometric properties of the Chinese and English versions for people of Chinese ethnicity in Australia. METHODS: A two-phase cross-sectional descriptive study was conducted. Phase 1: The questionnaire was translated into English using the back-translation method. The translation equivalence and content relevance were evaluated by an expert panel. Three items were revised and eight items were removed. Phase 2: Internal consistency and stability of the questionnaires were evaluated by a group of Chinese Australians. RESULTS: Both the English and Chinese versions had satisfactory psychometric properties. In phase 2, 146 participants completed the questionnaire (test), and 49 participants completed the retest. The Cronbach's alpha scores were 0.638 and 0.584 respectively, and the overall intra-class correlation coefficients were 0.820 and 0.688 respectively for the English and Chinese versions. The Item-Content Validity Index (CVI) ranged from 0.50 to 1.00. The Scale-CVI was 0.94. CONCLUSION: The DSRBQ has been translated into English. Both English and Chinese versions have acceptable validity and reliability. The tools can be used in people from a Chinese cultural background living in Australia. Further validation testing may allow the tools to be adapted for use with other Chinese diaspora groups. The validated DSRBQ will support the development of evidence-based salt reduction nursing assessment tool and interventions for Chinese diasporas who reside in a country where Chinese cultural practices are employed by a minority.

Tools to Assess the Risk of Bias and Reporting Quality of Randomized Controlled Trials in Rehabilitation.

OBJECTIVES: (1) To determine whether new tools and items have been developed to evaluate the risk of bias (RoB) and reporting of randomized controlled trials (RCTs) in rehabilitation; (2) to determine which items are included in the existing reporting guidelines, and to create a matrix of items to report and conduct trials in rehabilitation as the first step for a starting a rigorous validation process. DATA SOURCES: Searches were conducted in MEDLINE, EMBASE, and Cumulative Index to Nursing and Allied Health databases. STUDY SELECTION: Studies should describe a newly developed tool to evaluate the RoB or quality of reporting for RCTs in the area of rehabilitation. DATA EXTRACTION: (1) First, we extracted items from new tools identified by the electronic search strategies and then (2) we looked at the items provided by the Consolidated Standards of Reporting Trials statement and its relevant extensions. We determined whether these items were already included in our matrix of items. Items were classified based on methodological domains they accomplish, biases they were able to target, and whether they guide reporting or conduct. DATA SYNTHESIS: Among the 1596 citations found, 23 articles were potentially relevant. From these, only 3 new scales (National Institute for Complementary Medicine Acupuncture Network, Quality of reports on spa and balneotherapy [SPAC], Assessment of Study Quality and Reporting in Exercise) were found. In addition, the newly updated Cochrane RoB tool (RoB 2.0) was included. Our matrix contained 122 unique items for any rehabilitation area, 46 items (37.7%) were related to conduct, and 58 (47.5%) were related to the reporting; 18 (14.8%) were related to both. Overall, 76 new items were added among all domains. CONCLUSIONS: Many individual and diverse items have been used to guide the reporting and conduct of rehabilitation trials. This indicates a great variability in number of items and an apparent lack of consensus on a core set of items to be used in rehabilitation. Future research should look into developing a core set of items for the rehabilitation field.

Using the Choice Sequence in Time Trade-Off as Discrete Choices: Do the Two Stories Match?

OBJECTIVES: The EQ-5D-5L valuation protocol recommends combining time trade-off (TTO) and discrete choice experiments (DCEs). DCEs that include a duration attribute (DCETTO) allow modeling on the quality-adjusted life-year scale. Because the choice sequence in a TTO can be construed as a series of DCETTO, we used data from a single TTO study to investigate the extent to which DCE values match TTO values when based on identical preferences. METHODS: In a TTO design in which a fixed set of choices were administered without termination at preference indifference, 202 individuals each valued 10 EQ-5D health states. From identified indifference points, we estimated three sets of TTO values: (i) plotting means and (ii) applying censored regressions at -1 and 1. Using all strict preferences, we (iii) estimated DCETTO values with a logit model and a bootstrap procedure. RESULTS: Estimated DCETTO and TTO values agreed well at the severe end of the quality-adjusted life-year scale, but with decreasing severity, DCETTO values were higher than TTO-values, with the difference peaking at 0.37 for the mildest health state. Left-censoring TTO values at -1 worsen the agreement for the worst health states and did not affect health states. Right censoring at 1 improved the agreement for mild states. CONCLUSIONS: TTO and the DCETTO values estimated from the same preference data diverged, with increasing difference for milder health states. Although the values converged when applying censored regression at +1, we question the validity of this adjustment.

Qualitative research methods in medical dissertations: an observational methodological study on prevalence and reporting quality of dissertation abstracts in a German university.

BACKGROUND: Qualitative methods offer a unique contribution to health research. Academic dissertations in the medical field provide an opportunity to explore research practice. Our aim was to assess the use of qualitative methods in dissertations in the medical field. METHODS: By means of a methodological observational study, an analysis of all academic medical dissertations' abstracts between 1998 and 2018 in a repository databank of a large medical university faculty in Germany was performed. This included MD dissertations (Dr. med. (dent.)) and medical science dissertations (Dr. sc. hum.). All abstracts including "qualitativ*" were screened for studies using qualitative research methods. Data were extracted from abstracts using a category grid considering a) general characteristics (year, language, degree type), b) discipline, c) study design (mixed methods/qualitative only, data conduction, data analysis), d) sample (size and participants) and e) technologies used (data analysis software and recording technology). Thereby reporting quality was assessed. RESULTS: In total, 103 abstracts of medical dissertations between 1998 and 2018 (1.4% of N = 7619) were included, 60 of MD dissertations and 43 of medical sciences dissertations. Half of the abstracts (n = 51) referred to dissertations submitted since 2014. Most abstracts related to public health/hygiene (n = 27) and general practice (n = 26), followed by medical psychology (n = 19). About half of the studies (n = 47) used qualitative research methods exclusively, the other half (n = 56) used mixed methods. For data collection, primarily individual interviews were used (n = 80), followed by group interviews (n = 33) and direct observation (n = 11). Patients (n = 36), physicians (n = 36) and healthcare professionals (n = 17) were the most frequent research participants. Incomplete reporting of participants and data analysis was common (n = 67). Nearly half of the abstracts (n = 46) lacked information on how data was analysed, most of the remaining (n = 43) used some form of content analysis. In summary, 36 abstracts provided all crucial data (participants, sample size,; data collection and analysis method). CONCLUSION: A small number of academic dissertations used qualitative research methods. About a third of these reported all key aspects of the methods used in the abstracts. Further research on the quality of choice and reporting of methods for qualitative research in dissertations is recommended.

A tutorial on methodological studies: the what, when, how and why.

BACKGROUND: Methodological studies - studies that evaluate the design, analysis or reporting of other research-related reports - play an important role in health research. They help to highlight issues in the conduct of research with the aim of improving health research methodology, and ultimately reducing research waste. MAIN BODY: We provide an overview of some of the key aspects of methodological studies such as what they are, and when, how and why they are done. We adopt a "frequently asked questions" format to facilitate reading this paper and provide multiple examples to help guide researchers interested in conducting methodological studies. Some of the topics addressed include: is it necessary to publish a study protocol? How to select relevant research reports and databases for a methodological study? What approaches to data extraction and statistical analysis should be considered when conducting a methodological study? What are potential threats to validity and is there a way to appraise the quality of methodological studies? CONCLUSION: Appropriate reflection and application of basic principles of epidemiology and biostatistics are required in the design and analysis of methodological studies. This paper provides an introduction for further discussion about the conduct of methodological studies.

Reporting and handling of incomplete outcome data in implant dentistry: A survey of randomized clinical trials.

AIM: To assess the reporting and handling of incomplete outcome data in randomized clinical trials (RCTs) published in implant dentistry. MATERIALS AND METHODS: We included RCTs on interventions related to the treatment with dental implants and presented any form of missing data. PubMed, SCOPUS and Cochrane databases were searched for studies published between May 2015 and May 2018. Reporting and handling of missing data at the study level were evaluated using a series of relevant questions. Descriptive data were reported, and univariable analyses were performed to evaluate the association of study variables with quality of reporting and data handling. RESULTS: One-hundred and thirty-seven RCT reports were included from the 7,116 initially retrieved publications. The reporting of incomplete outcome data varied greatly among the trials and for the different questions. The range of adequately reported questions was between 3.64% (question: comparison of baseline characteristics of all randomised participants) and 100% (question: explicit reporting of missing data). The complete case analysis was the most used (45.3%) approach for incomplete outcome data handling. CONCLUSIONS: Randomized studies in implant dentistry have room for improvement in both the reporting and the handling of incomplete outcome data.

Partnering with persons in long-term recovery from substance use disorder: experiences from a collaborative research project.

BACKGROUND: Traditional research about substance use disorder (SUD) treatment is considered, among an increasing number of service users, to be disempowering and poorly reflective of their priorities. Thus, this methodological article sought to examine the experiences of a peer research group (PRG), whose four members were in long-term SUD recovery, and a principal investigator (PI), when collaborating on a study of SUD recovery. This article has also aspired to discern the influence of peer researcher participation on the research process. The purpose of the qualitative research project that formed the basis of this methodological study was to examine the reasons provided and strategies employed for abstaining from problematic substance use among persons with SUDs. METHODS: The project took place from 2015 to 2018, during which time individual interviews were conducted with 18 persons in recovery from SUDs. The PRG contributed to all parts of the project and worked alongside the PI in preparing the study, during early stages of data analysis, and while writing up the findings. In total, ten group discussions were held over the course of 3 years. RESULTS: The study showed that the PRG offered important contributions with respect to developing the interview guide, preunderstanding among the PRG members, and discussing alternative forms of data collection. Key findings about how this collaborative research process was experienced relate to three matters: the group aspect of participation, the value of predictable routines and clear expectations, and the open sharing of private matters. The PI experienced the research process as having been enriched by alternative ways of asking questions and interpreting findings and as an interactive arena for reciprocal social and professional support. CONCLUSIONS: When establishing a PRG while studying recovery processes, it can be advantageous to include several peer researchers with diverse lived experiences concerning substance use, treatment, and recovery. If possible, at least one peer researcher with formal training or qualitative research experience might be included. The PI should be trained in collaborating with peer researchers or should be part of a research environment in which it is possible to discuss methodological challenges with other researchers.

Psychometric evaluation of the Informed Consent Process Scale in Chinese.

BACKGROUND: Informed consent is essential for the ethical conduct of clinical research and is a culturally sensitive issue. But, a measurable Chinese version of the scale to evaluate the informed consent process has not yet been explored in the existing literature. RESEARCH OBJECTIVES: This study aimed to develop and psychometrically test the Chinese version of the Informed Consent Process Scale. RESEARCH DESIGN: Back-translation was conducted to develop the Chinese version of the questionnaire. A cross-sectional survey was administered, after which an exploratory factor analysis was conducted. PARTICIPANTS: We recruited a total of 375 participants who had experience in signing an informed consent form within the previous 3 years in Taiwan. ETHICAL CONSIDERATIONS: This study was approved by two Institutional Review Boards and the autonomy of the participants was respected. FINDINGS: The Chinese version of the Informed Consent Process Scale is composed of three factors with 23 items showing evidence of acceptable reliability and validity. Three major factors were extracted and labeled: Factor 1 - 'Understanding of the research', Factor 2 - 'Trust and confidence' and Factor 3 - 'Doubt and uncertainty'. The three factors accounted for is 52.954 of the total variance with Cronbach's α of .917. DISCUSSION AND CONCLUSION: The finding corroborates previous studies showing that participants had too little understanding on the informed consent forms they signed and implied the need to clarify the critical points in clinical research. The psychometric results indicated good internal consistency and validity for this newly constructed instrument, and it was found worthy of conducting further testing and application.

Validity and reliability study for the Turkish version of global pain scale.

INTRODUCTION: To investigate the validity and reliability of the "Global Pain Scale" for Turkish population . METHODS: The cross-sectional study was conducted at the Algology outpatient clinic of a university hospital in Izmir, Turkey, between March and December 2015, and comprised patients with chronic pain aged at least 18 years. Linguistic equivalence, content validity and construct validity were used for establishing the validity of the Global Pain Scale, while the Content Validity Index was used for the assessment of expert views. SPSS 16was used for data analysis. RESULTS: Of the 222 subjects, 142(64%) were females. Overall mean age of the sample was 54.22±13.79 years. Cronbach's alpha coefficient for the entire scale was 0.95. Total item correlation coefficients of the items in the scale ranged between 0.502 and 0.794, and no items were removed from the scale. CONCLUSIONS: The Global Pain Scale was found to have adequate validity and reliability indicators, and can be used with confidence in patients experiencing chronic pain.

Generation and application of human induced-stem cell memory T cells for adoptive immunotherapy.

Adoptive T-cell therapy is an effective strategy for cancer immunotherapy. However, infused T cells frequently become functionally exhausted, and consequently offer a poor prognosis after transplantation into patients. Adoptive transfer of tumor antigen-specific stem cell memory T (TSCM ) cells is expected to overcome this shortcoming as TSCM cells are close to naïve T cells, but are also highly proliferative, long-lived, and produce a large number of effector T cells in response to antigen stimulation. We previously reported that activated effector T cells can be converted into TSCM -like cells (iTSCM ) by coculturing with OP9 cells expressing Notch ligand, Delta-like 1 (OP9-hDLL1). Here we show the methodological parameters of human CD8+ iTSCM cell generation and their application to adoptive cancer immunotherapy. Regardless of the stimulation by anti-CD3/CD28 antibodies or by antigen-presenting cells, human iTSCM cells were more efficiently induced from central memory type T cells than from effector memory T cells. During the induction phase by coculture with OP9-hDLL1 cells, interleukin (IL)-7 and IL-15 (but not IL-2 or IL-21) could efficiently generate iTSCM cells. Epstein-Barr virus-specific iTSCM cells showed much stronger antitumor potentials than conventionally activated T cells in humanized Epstein-Barr virus transformed-tumor model mice. Thus, adoptive T-cell therapy with iTSCM offers a promising therapeutic strategy for cancer immunotherapy.

How is AMSTAR applied by authors - a call for better reporting.

BACKGROUND: The assessment of multiple systematic reviews (AMSTAR) tool is widely used for investigating the methodological quality of systematic reviews (SR). Originally, AMSTAR was developed for SRs of randomized controlled trials (RCTs). Its applicability to SRs of other study designs remains unclear. Our objectives were to: 1) analyze how AMSTAR is applied by authors and (2) analyze whether the authors pay attention to the original purpose of AMSTAR and for what it has been validated. METHODS: We searched MEDLINE (via PubMed) from inception through October 2016 to identify studies that applied AMSTAR. Full-text studies were sought for all retrieved hits and screened by one reviewer. A second reviewer verified the excluded studies (liberal acceleration). Data were extracted into structured tables by one reviewer and were checked by a second reviewer. Discrepancies at any stage were resolved by consensus or by consulting a third person. We analyzed the data descriptively as frequencies or medians and interquartile ranges (IQRs). Associations were quantified using the risk ratio (RR), with 95% confidence intervals. RESULTS: We identified 247 studies. They included a median of 17 reviews (interquartile range (IQR): 8 to 47) per study. AMSTAR was modified in 23% (57/247) of studies. In most studies, an AMSTAR score was calculated (200/247; 81%). Methods for calculating an AMSTAR score varied, with summing up all yes answers (yes = 1) being the most frequent option (102/200; 51%). More than one third of the authors failed to report how the AMSTAR score was obtained (71/200; 36%). In a subgroup analysis, we compared overviews of reviews (n = 154) with the methodological publications (n = 93). The overviews of reviews were much less likely to mention both limitations with respect to study designs (if other studies other than RCTs were included in the reviews) (RR 0.27, 95% CI 0.09 to 0.75) and overall score (RR 0.08, 95% CI 0.02 to 0.35). CONCLUSIONS: Authors, peer reviewers, and editors should pay more attention to the correct use and reporting of assessment tools in evidence synthesis. Authors of overviews of reviews should ensure to have a methodological expert in their review team.