METHODS: In this cross-sectional study among 570 YMSM aged 18 to 25 years old, latent class analysis (LCA) conducted to identify classes with similar patterns of sexualized substance use, across which measures of inconsistent condom use, recent STI diagnoses, past suicide ideation and depression severity were compared.
RESULTS: LCA revealed three classes of YMSM based on types of substances ever used in sexualized contexts, which we labelled as 'substance-naive', 'substance-novice', and 'chemsex'. Substance-naive participants (n = 404) had only ever used alcohol, while substance-novice participants (n = 143) were primarily amyl nitrite users with a small proportion who reported using chemsex-related drugs. Chemsex participants (n = 23) comprised individuals who had mostly used such drugs. Those in the chemsex group were more likely to report recent unprotected anal sex with casual partners (aPR = 3.28, 95%CI [1.85, 5.79]), depression severity (aβ = 3.69, 95%CI [0.87, 6.51]) and a history of suicide ideation (aPR = 1.64, 95%CI [1.33, 2.03]).
CONCLUSIONS: Findings of this study highlight how the use of varying substances in sexualized contexts may be classified and characterized by different sexual and mental health outcomes. Health promotion efforts should be differentiated accordingly to address the risks associated with sexualized substance use among YMSM.
METHODS: In this cross sectional study, the Malay version of SAQLI was administered to 82 OSA patients seen at the OSA Clinic, Hospital Universiti Sains Malaysia prior to their treatment. Additionally, the patients were asked to complete the Malay version of Medical Outcomes Study Short Form (SF-36). Twenty-three patients completed the Malay version of SAQLI again after 1-2 weeks to assess its reliability.
RESULTS: Initial factor analysis of the 40-item Malay version of SAQLI resulted in four factors with eigenvalues >1. All items had factor loadings >0.5 but one of the factors was unstable with only two items. However, both items were maintained due to their high communalities and the analysis was repeated with a forced three factor solution. Variance accounted by the three factors was 78.17% with 9-18 items per factor. All items had primary loadings over 0.5 although the loadings were inconsistent with the proposed construct. The Cronbach's alpha values were very high for all domains, >0.90. The instrument was able to discriminate between patients with mild or moderate and severe OSA. The Malay version of SAQLI correlated positively with the SF-36. The intraclass correlation coefficients for all domains were >0.90.
CONCLUSIONS: In light of these preliminary observations, we concluded that the Malay version of SAQLI has a high degree of internal consistency and concurrent validity albeit demonstrating a slightly different construct than the original version. The responsiveness of the questionnaire to changes in health-related quality of life following OSA treatment is yet to be determined.
OBJECTIVE: This 12-week pilot study examines the efficacy of applying low frequency sound wave stimulation (between 16-160 Hz) through both hands and feet on relieving pain and improving functional ability in patients with chronic back pain.
METHODS: Twenty-three participants with chronic shoulder (eleven participants) or low back pain (twelve participants) underwent a 12-week vibration therapy program of three sessions per week. A low frequency sound wave device comprising four piezoelectric vibration-type tactile tranducers enclosed in separate 5-cm diameter circular plates, which generate sinusoidal vibratory stimuli at a frequency of 16-160 Hz, was used in this study. Primary outcome measure was pain sensation measured using the Visual Analogue Scale (P-VAS). The secondary outcome measures were pain-related disability measured using the pain disability index (PDI) and quality of life measured using the SF-12.
RESULTS: At week 12, significant reductions in pain sensation and pain-related disability were observed, with mean reductions of 3.5 points in P-VAS and 13.5 points in the PDI scores. Sixty-five percent of the participants had a reduction of at least 3 points on the P-VAS score, while 52% participants showed a decrease of at least 10 points in the PDI score. Significant improvement was observed in the SF-12 physical composite score but not the mental composite score.
CONCLUSIONS: The preliminary findings showed that passive application of low frequency sound wave stimulation therapy through both hands and feet was effective in alleviating pain and improving functional ability in patients with chronic back pain.
METHODS: Patients were randomly assigned to double-blind treatment for 6 weeks with lurasidone, 20-60 mg/day (n = 184) or 80-120 mg/day (n = 169), or placebo (n = 172). The primary end-point was change from baseline to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS).
RESULTS: Lurasidone treatment significantly reduced mean MADRS total scores from baseline to Week 6 for the 20-60-mg/day group (-13.6; adjusted P = 0.007; effect size = 0.33), but not for the 80-120-mg/day group (-12.6; adjusted P = 0.057; effect size = 0.22) compared with placebo (-10.6). Treatment with lurasidone 20-60 mg/day also improved MADRS response rates, functional impairment, and anxiety symptoms. The most common adverse events associated with lurasidone were akathisia and nausea. Lurasidone treatments were associated with minimal changes in weight, lipids, and measures of glycemic control.
CONCLUSION: Monotherapy with once daily doses of lurasidone 20-60 mg, but not 80-120 mg, significantly reduced depressive symptoms and improved functioning in patients with bipolar I depression. Results overall were consistent with previous studies, suggesting that lurasidone 20-60 mg/day is effective and safe in diverse ethnic populations, including Japanese.
METHODS: VALID is a prospective, multi-center, multinational validation study that will assess the accuracy and feasibility of measuring VA function, defined as the need for interventions to enable and maintain the use of a VA for HD. The primary objective is to determine whether VA function can be measured accurately by clinical staff as part of routine clinical practice (Assessor 1) compared to the reference standard of documented VA procedures collected by a VA expert (Assessor 2) during a 6-month follow-up period. Secondary outcomes include feasibility and acceptability of measuring VA function and the time to, rate of, and type of VA interventions. An estimated 612 participants will be recruited from approximately 10 dialysis units of different size, type (home-, in-center and satellite), governance (private versus public), and location (rural versus urban) across Australia, Canada, Europe, and Malaysia. Validity will be measured by the sensitivity and specificity of the data acquisition process. The sensitivity corresponds to the proportion of correctly identified interventions by Assessor 1, among the interventions identified by Assessor 2 (reference standard). The feasibility of measuring VA function will be assessed by the average data collection time, data completeness, feasibility questionnaires and semi-structured interviews on key feasibility aspects with the assessors.
DISCUSSION: Accuracy, acceptability, and feasibility of measuring VA function as part of routine clinical practice are required to facilitate global implementation of this core outcome across all HD trials. Global use of a standardized, patient-centered outcome measure for VA function in HD research will enhance the consistency and relevance of trial evidence to guide patient-centered care.
TRIAL REGISTRATION: Clinicaltrials.gov: NCT03969225. Registered on 31st May 2019.
METHODS: Forty-eight hospital departments were recruited via open call and stratified by country. Departments were assigned to the operational program (intervention) or usual routine (control group). Data for analyses included 36 of these departments and their 5285 patients (median 147 per department; range 29-201), 2529 staff members (70; 10-393), 1750 medical records (50; 50-50), and standards compliance assessments. Follow-up was measured after 1 year. The outcomes were health status, service delivery, and standards compliance.
RESULTS: No health differences between groups were found, but the intervention group had higher identification of lifestyle risk (81% versus 60%, p health effects, the bias, and the limitations should be considered in implementation efforts and further studies.
TRIAL REGISTRATION: ClinicalTrials.gov : NCT01563575. Registered 27 March 2012. https://clinicaltrials.gov/ct2/show/NCT01563575.
MATERIALS AND METHODS: Overall methods were guided by the Core Outcome Set Measures in Effectiveness Trials (COMET) initiative. Initial outcome identification was achieved from focus groups with PWLE employing calibrated methods across two low-middle-income countries (China and Malaysia) and two high-income countries (Spain and the United Kingdom). Following consolidation of the results, the outcomes were incorporated into a three-stage Delphi process with PWLE participation. Finally, consensus between PWLE and DPs was achieved using a mixed live and recorded platform. The experiences of PWLE involvement in the process was also evaluated.
RESULTS: Thirty-one PWLE participated in four focus groups. Thirty-four outcomes were suggested across the focus groups. Evaluation of the focus groups revealed a high level of satisfaction with the engagement process and some new learning. Seventeen PWLE contributed to the first 2 Delphi rounds and 7 to the third round. The final consensus included 17 PWLE (47%) and 19 DPs (53%). Out of the total of 11 final consensus outcomes considered essential by both PWLE and health professionals, 7 (64%) outcomes mapped across to ones that PWLE initially identified, broadening their definition. One outcome (PWLE effort required for treatment and maintenance) was entirely novel.
CONCLUSIONS: We conclude that engaging PWLE in COS development can be achieved across widely different communities. Furthermore, the process both broadened and enriched overall outcome consensus, yielding important and novel perspectives for health-related research.
MATERIALS AND METHODS: Overall methods were guided by the Core Outcome Set Measures in Effectiveness Trials (COMET) initiative. Initial outcome identification was achieved from focus groups with PWLE employing calibrated methods across two low-middle-income countries (China and Malaysia) and two high-income countries (Spain and the United Kingdom). Following consolidation of the results, the outcomes were incorporated into a three-stage Delphi process with PWLE participation. Finally, consensus between PWLE and DPs was achieved using a mixed live and recorded platform. The experiences of PWLE involvement in the process was also evaluated.
RESULTS: Thirty-one PWLE participated in four focus groups. Thirty-four outcomes were suggested across the focus groups. Evaluation of the focus groups revealed a high level of satisfaction with the engagement process and some new learning. Seventeen PWLE contributed to the first 2 Delphi rounds and 7 to the third round. The final consensus included 17 PWLE (47%) and 19 DPs (53%). Out of the total of 11 final consensus outcomes considered essential by both PWLE and health professionals, 7 (64%) outcomes mapped across to ones that PWLE initially identified, broadening their definition. One outcome (PWLE effort required for treatment and maintenance) was entirely novel.
CONCLUSIONS: We conclude that engaging PWLE in COS development can be achieved across widely different communities. Furthermore, the process both broadened and enriched overall outcome consensus, yielding important and novel perspectives for health-related research.
METHODS AND ANALYSIS: A long list of outcomes will be generated using (1) a systematic review of existing studies on OA-TOF and (2) qualitative research with children (patients), adults (patients) and families involving focus groups, semistructured interviews and self-reported outcome activity packs. A two-phase Delphi survey will then be completed by four key stakeholder groups: (1) patients (paediatric and adult); (2) families; (3) healthcare professionals; and (4) researchers. Phase I will include stakeholders individually rating the importance and relevance of each long-listed outcome using a 9-point Likert scale, with the option to suggest additional outcomes not already included. During phase II, stakeholders will review summarised results from phase I relative to their own initial score and then will be asked to rescore the outcome based on this information. Responses from phase II will be summarised using descriptive statistics and a predefined definition of consensus for inclusion or exclusion of outcomes. Following the Delphi process, stakeholder experts will be invited to review data at a consensus meeting and agree on a COS for OA-TOF.
ETHICS AND DISSEMINATION: Ethical approval was sought through the Health Research Authority via the Integrated Research Application System, registration no. 297026. However, approval was deemed not to be required, so study sponsorship and oversight were provided by Alder Hey Children's NHS Foundation Trust. The study has been prospectively registered with the COMET Initiative. The study will be published in an open access forum.