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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: Work-family enrichment refers to the extent to which experiences in one role improve the quality of life in another role, and the bidirectionality indicates that benefits derived from work can be applied to family and vice versa. Parent nurses, that is, female nurses who are raising preschool children, play a major role at work and in the family. Thus, work-family enrichment is significant for them. The Work-Family Enrichment Scale cannot be generalized to parent nurses. This study was aimed at developing and psychometrically validating a draft Work-Family Enrichment Scale for Parent Nurses. Methods: A questionnaire survey was conducted among 1,090 parent nurses who were randomly sampled from hospitals with more than 200 beds in Japan. The survey evaluated (1) a draft Work-Family Enrichment Scale for Parent Nurses, (2) the Japanese version of the Work-Family Enrichment Scale, and (3) the Positive Spillover Scale. The scales were psychometrically evaluated for internal consistency, construct validity, and criterion-related validity. Results: Data from 503 participants (age, mean ± standard deviation [range] 35.5 ± 4.96 [23–47] years) were analyzed. Results of exploratory factor analysis, the work to family enrichment direction yielded five factors for 23 items: "emotional fulfillment," "efficiency," "ability to lead," "displaying industriousness," and "self-growth." Cronbach's alpha coefficients ranged from 0.862 to 0.914. In the family-to-work enrichment direction, there were five factors for 28 items: "help-seeking," "receptiveness," "expansion of one's horizon," "efficiency," and "emotional fulfillment." Cronbach's alpha coefficients ranged from 0.790 to 0.907. Additionally, the correlation coefficients reporting criterion-related validity were 0.685 and 0.619 with regard to the Japanese version of the Work-Family Enrichment Scale and 0.596 and 0.534 with the Positive Spillover Scale for the Work-to-Family Enrichment Scale and the Family-to-Work Enrichment Scale for Parent Nurses, respectively. Conclusions: The Work-Family Enrichment Scale for Parent Nurses has adequate reliability and validity and can be used as an effective measure to assess the positive aspects of work and family roles among female parent nurses. [ABSTRACT FROM AUTHOR]

Background: Given increases in China's aging population, the growing demand for public health services and the shortage of human resources among nurses have become more prominent. Under such a background, "Internet + Nursing Services" have received more attention. Thus, exploring the barriers to and facilitators of nurses' willingness to participate in "Internet + Nursing Services" and utilizing internet technology to increase the supply of nursing services has become a key issue. Objective: This study aimed to develop a scale for assessing the barriers to and facilitators of nurses' willingness to participate in "Internet + Nursing Services" and to test the validity and reliability of the scale. Methods: A preliminary scale was developed based on a literature review, theoretical research, semistructured qualitative interviews, and two rounds of Delphi expert inquiry. A convenient sampling method was used for the questionnaire survey. A 5-point Likert scale was used to evaluate the importance of the items. The survey data of 659 clinical nurses obtained from February to March 2023 were used for item analysis, exploratory factor analysis (EFA), and reliability and validity tests of the scale. The survey data of 538 clinical nurses obtained in April 2023 were used for confirmatory factor analysis (CFA) of the final scale. Results: The final scale consists of 25 items and 4 dimensions (performance expectations, perceived risk, need for professional knowledge training, and nonprofessional knowledge training). The scale showed good structural validity and content validity: the Cronbach's α coefficient of the scale was 0.955, the split-half reliability was 0.778, the test-retest reliability was 0.944, the kaiser-meyer-olkin(KMO) value was 0.960, and the cumulative variance contribution rate of the 4 common factors was 83.147%. The scale content validity index(S-CVI) was 0.914. The confirmatory factor analysis model had favorable fit indices: χ2/df = 4.234, RMSEA = 0.078, NFI = 0.940, IFI = 0.953, TLI = 0.947, and CFI = 0.953. Conclusion: The scale for assessing the barriers to and facilitators of nurses' willingness to participate in "Internet + Nursing Services" has good reliability and validity, and provides a reference for evaluating nurses' willingness to participate in "Internet + Nursing Services". [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes mellitus is associated with cognitive dysfunction and an increased risk of dementia. Linagliptin is a glucose-lowering agent of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class that is of particular interest for the prevention of accelerated cognitive decline, because it may potentially benefit the brain through pleiotropic effects, beyond glucose lowering. This paper presents the design of a study that aims to establish if linagliptin is superior to the sulfonylurea glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus.Methods: The cognition substudy is an integral part of the ongoing event-driven, randomised, double blind CARdiOvascular safety of LINAgliptin (CAROLINA®) trial, which evaluates the effect of treatment with linagliptin versus glimepiride on cardiovascular outcomes. CAROLINA® includes patients with type 2 diabetes mellitus with sub-optimal glycaemic control at elevated cardiovascular risk. The substudy will evaluate patients randomised and treated who have a baseline Mini Mental State Examination (MMSE) score ≥ 24, documented years of formal education with at least one valid cognitive assessment at baseline and during follow-up. The primary cognitive outcome is the occurrence of accelerated cognitive decline at the end of follow-up. The two treatment groups will be compared by using a logistic regression. Accelerated cognitive decline is defined as a rate of cognitive decline that falls at or below the 16th percentile of decline for the whole cohort on either the MMSE or a combined score of the trail making and verbal fluency test. Potential confounders are taken into account at an individual patient level, using a regression based index.Discussion: Between December 2010 and December 2012, 6042 patients were randomised and treated with either linagliptin (5 mg) or glimepiride (1-4 mg) once daily in CAROLINA®. Cognitive tests were conducted in nearly 4500 participants at baseline and are scheduled for two subsequent assessments, after 160 weeks of follow-up and end of follow-up. This substudy of the ongoing CAROLINA® trial will establish if linagliptin is superior to glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus. Final results are expected in 2019.Trial Registration: ClinicalTrials.gov Identifier: NCT 01243424 . [ABSTRACT FROM AUTHOR]

Background: Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases.Methods: This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice.Discussion: This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases.Trial Registration: ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016. [ABSTRACT FROM AUTHOR]

Background: The evolving approach of health literate health care organizations (HLHO) receives considerable support from health policy makers. Up to now, there are no performance measures available to assess the application of health literacy strategies by health care professionals in the primary care setting. This paper describes the development and validation of the Health Literate Primary Care Practice screener (HLPC). The screener can be used as a self-assessment tool for primary care organizations (PCO) that aim to elucidate the health literacy responsiveness of their organization. Methods: The HLPC is a 4-item screener developed in a multi-level process following a theory-driven approach including a literature review, consultations with scientists and cognitive tests with patients in PCO. The screener was applied in a national random sample of N = 1125 adults living in Germany. Item and psychometric properties were analyzed by determining item discrimination and reliability as well as performing a confirmatory factor analysis (CFA) to test the instruments unidimensionality. Criterion validity was investigated by performing bivariate correlations between the HLPC score and heath care quality measures. Results: The HLPC scale demonstrated good item discrimination and internal consistency (α = 0.86). CFA verified a one-factor structure of the scale and analysis on the criterion validity revealed a significant correlation between the HLPC score and patients satisfaction with the general practitioner, accessibility of the PCO and support in care-coordination received in the PCO. Conclusions: The HLPC is a valid screener to provide insights in the extent of the utilization of health literacy strategies in primary care practices. [ABSTRACT FROM AUTHOR]

Background: Many women throughout the world have history of subfertility (resolved or unresolved), but much remains unknown about services and treatments chosen. Methods: We developed a mixed-mode fertility experiences questionnaire (FEQ) in 2009 through literature review and iterative pilot work to optimize question format and mode of administration. The focus of the FEQ is to collect data retrospectively on time at risk for pregnancy, fertility treatments received and declined, pregnancy, time to pregnancy and pregnancy outcomes. We conducted a validation of key elements of the FEQ with comparison to medical records in 2009 and 2010. The validation sample was selected from women initially seen at a specialized fertility treatment center in Utah in 2004. Results: The FEQ was optimized with two components: 1) written (paper or web-based), self-administered, followed by 2) telephone- administered questions. In 63 patients analyzed, high levels of correlation were identified between patient self-report and medical records for the use of intrauterine insemination and assisted reproductive technology, pregnancy and live birth histories, time at risk for pregnancy and time to pregnancy. There was low correlation between medical records and self-report for the use of oral ovulation drugs and injectable ovulation drugs. Compared to the medical record, the FEQ was over 90 % sensitive for all elements, except injectable ovulation drugs (70 % sensitivity). Conclusions: The FEQ accurately captured elements of fertility treatment history at 5-6 years after the first visit to a specialty clinic. [ABSTRACT FROM AUTHOR]

Background: China is experiencing an aging population, leading to a significant demand for "Internet + nursing services" tailored for elderly individuals. However, there are many risk problems in the process of nurse service, which hinder the development of the service, and a scale is needed to assess the risk problems faced by nurses in "Internet + nursing services" for the elderly. Objective: The purpose of this study is to develop an assessment scale for risk factors and outcomes related to nurses' involvement in the "Internet + Nursing Service" for the elderly and to assess its reliability and validity. Methods: Based on literature analysis, focus group, the Delphi method, and a presurvey, we designed an initial scale. The initial scale comprised two sections: risk factors and risk outcomes for nurses. In January and February of 2023, nurses engaged in "Internet + nursing services" for the elderly in Shanxi Province were chosen through a convenience sampling technique for a questionnaire survey. Subsequently, item analysis and exploratory factor analysis were employed to refine and develop a test version of the scale further. A follow-up questionnaire survey was carried out in March and April 2023 using a similar approach. The reliability and validity of the scale were assessed through confirmatory factor analysis, culminating in the formation of the final scale. Results: The initial survey yielded 244 valid responses. The cumulative variance contributions of the two segments from the exploratory factor analysis were 84.584% and 90.089%, respectively. A subsequent survey garnered 220 valid responses. The confirmatory factor analysis results indicated: χ2/df = 2.086, comparative fit index (CFI) = 0.918, normative fit index (NLI) = 0.855, root mean square of residuals (RMR) = 0.045, and root mean square of error of approximation (RMSEA) = 0.070. These results demonstrate good structural, convergent, and discriminant validity. The content validity index at the item level (I-CVI) ranged between 0.875 and 1.000, while the content validity index at the scale level (S-CVI/Ave) was 0.941. Cronbach's alpha coefficient for the entire scale stood at 0.970. Moreover, the scale exhibited a split-half reliability of 0.876 and a retest reliability of 0.980 (p < 0.01). Conclusion: The risk factors and risk outcomes associated with nurses involved in "Internet + nursing services" for elderly individuals, as developed in this study, demonstrate strong reliability and validity. They are well suited to the Chinese national context. [ABSTRACT FROM AUTHOR]

Background: Palliative care is mainly restricted to terminal care. General practitioners (GPs) are not trained to early identify palliative patients with cancer, COPD or heart failure. With the help of the RADboud indicators for PAlliative Care needs (RADPAC), we trained GPs to identify patients' needs and to make a proactive care plan. They were also able to join two role-plays where they discussed the patient's future, and consulted a palliative care consultant to fine-tune the care plan. We evaluated the programme with the GPs and consultants and noted its impact on their daily practice. Methods: Two years after they had participated in the programme, we held semi-structured interviews with the GPs and a focus group interview with the consultants and performed a thematic content analysis. Results: Six consultants and nine GPs participated in the programme. Most GPs and consultants mentioned positive changes in the thinking or acting of GPs regarding early palliative care. A number continued to use the tool to identify patients; most of the others noted they had internalised the indicators. Although half of them still considered discussing end-of-life aspects difficult, particularly in patients with organ failure, the others were more easily able to discuss the future with their palliative patients. Conclusion: Although most GPs and consultants were positive about the training programme and applying it in daily practice, we conclude that in future programmes, more attention needs to paid to timely identification of palliative patients with COPD or CHF and how to discuss the future with them. [ABSTRACT FROM AUTHOR]

Background: Providing quality palliative care in residential aged care facilities (RACFs) (aged care homes) is a high priority for ageing populations worldwide. Older people admitted to these facilities have palliative care needs. Nursing assistants (however termed) are the least qualified staff and provide most of the direct care. They have an important role at the frontline of care spending more time with residents than any other care provider but have been found to lack the necessary knowledge and skills to provide palliative care. The level of competence of this workforce to provide palliative care requires evaluation using a valid and reliable instrument designed for nursing assistants' level of education and the responsibilities and practices of their role. Method: The overall study purpose was to develop and test an instrument capable of evaluating the knowledge, skills and attitudes of nursing assistants within a palliative approach in RACFs. Development consisted of a four-phase mixed-methods sequential design. In this paper, the results and key findings following psychometric testing of the instrument in Phase 4 is reported using data collected from a random sample of 17 RACFs and 348 nursing assistants in the Greater Sydney region. Study hypotheses were tested to confirm discriminative validity and establish the utility of the instrument in both research and training assessment. Results: Individual item properties were analysed for difficulty, discrimination and item-total correlations. Discriminative and structural validity, and internal consistency and test-retest reliability were demonstrated. Three separate questionnaires comprising 40 items were finalised: The Palliative Approach for Nursing Assistants (PANA)_Knowledge Questionnaire (17 items), the PANA_Skills Questionnaire (13 items) and the PANA_Attitudes Questionnaire (10 items). Conclusions: This study provides preliminary evidence for the validity and reliability of three new questionnaires that demonstrate sensitivity for nursing assistants' level of education and required knowledge, skills and attitudes for providing a palliative approach. Implications for practice include the development of palliative care competencies through structured education and training across this workforce, and ongoing professional development opportunities for nursing assistants, especially for those with the longest tenure. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to develop a new chewing problem directory (CPD) and validate it with oral health indicators such as total occlusion force, number of natural and rehabilitated teeth (NRT), NRT posterior, natural teeth, natural teeth posterior, and dental status among Korean elders. Background: Chewing problem is the main oral health problem in elders. However, there has been no validated tool using both subjective and objective assessment of chewing problem. Subjects and methods: A total of 537 participants aged 65 years or more were randomly assigned into 2 subsamples: developing sample (n = 260) for developing and internally validating the new CPD as the 1st stage and confirmation sample (n = 277) for confirming validation of CPD as the 2nd stage. CPD was developed using three subjective questionnaires (general eating, chewing nuts, and chewing meat problem) and objective NRT. Periodontitis, age, sex, education, smoking, alcohol drinking, metabolic syndrome, and frailty were considered as confounders. Following the development of CPD, CPD was validated using multiple multivariable logistic regression after controlling for confounders in confirmation sample and total sample. Results: The Cronbach's alpha value for three subjective questionnaires of CPD was 0.87. Among oral health indicators, NRT (0–28) showed the highest impact association with subjective chewing problem score (partial r = − 0.276). The chewing problem from the new CPD was associated with all items of oral health indicators. The prevalence of chewing problems by CPD was 57.7% in developing sample. Elders with NRT ≤ 24, compared with those with NRT ≥ 25, showed the highest impact on chewing problems by new CPD (Odds Ratio = 7.3 in the confirmation sample and 5.04 in the total sample, p < 0.05) among oral health indicators. Conclusion: This new CPD was developed as a valid tool to evaluate the chewing problem for Korean elders in dental clinics and community-based settings. [ABSTRACT FROM AUTHOR]

Importance: Patients with long-term neurological conditions, such as Parkinson's disease (PD), are particularly vulnerable to the public health measures taken to combat the COVID-19 pandemic. The inaccessibility of center-based rehabilitation further aggravated their motor dysfunctions as well as mental distress, leading to exacerbation of motor and non-motor symptoms, high healthcare utilization and worsened health-related quality of life (HRQOL). Objective: This study aimed to evaluate the feasibility, safety, and preliminary effects of the mHealth-delivered home-based mindfulness yoga program on functional balance, motor symptoms, mental health and HRQOL in patients with PD. Design, setting and participants: This prospective, single-arm, non-randomized feasibility study adopted a sequential explanatory mixed-method design. Adults (aged ≥ 18) with a clinical diagnosis of idiopathic Parkinson's disease (Hoehn and Yahr stage I to III) who were able to stand unaided and walk with or without an assistive device were enrolled via convenience sampling. Intervention: Home-based mindfulness yoga training were delivered via video-conferencing software (Zoom) in eight bi-weekly 90-min sessions. Main outcomes and measures: This current study measured functional balance, motor symptoms, perceived balance confidence, perceived freezing of gait symptoms, anxiety and depression, mindfulness and HRQOL using a tele-assessment approach at baseline and 1-week post-intervention. All participants were invited to attend qualitative individual interviews to explore their experience of using online mindfulness yoga program as a lifestyle intervention for PD rehabilitation. Results: Among the ten patients, 80% completed the program with an adherence rate of 98.4%. All participants were able to learn and practice mindfulness yoga following the eight bi-weekly online mindfulness yoga training sessions, without any significant adverse events. Tele-assessment of outcomes were feasible and uneventful. Qualitative feedback revealed participants had a high preference of using the tele-rehabilitation approach to stay mindful and being active, both physically and socially, while confronting the changes brought by COVID-19 pandemic. Conclusions and relevance: The mHealth-delivered home-based mindfulness yoga intervention was feasible, safe, and well-accepted among people with PD to relieve the burden brought by COVID-19 pandemic. Future studies should adopt a design with enhanced rigor, a comparison group, and enlarged sample size to evaluate the efficacy of the program in patients with long-term neurological conditions and/or physical impairments. We recommend a longer intervention duration of at least 8 weeks to enhance the psychophysiological effects. [ABSTRACT FROM AUTHOR]

Background: This study aimed to design a gamified smartphone application (app) and assess its efficacy for education of mothers regarding oral healthcare of their children. Methods: In this pretest–posttest controlled clinical trial, a simple app and a gamified version of it were designed to enhance the oral health knowledge and practice of mothers. The app contains information about early childhood caries, health diet, sugars, baby-oral hygiene, fluoride effect, fluoride toothpaste, tooth-brushing training video and regular dental visits. The opinion of experts and 3 mothers were obtained and both apps were revised accordingly. The intervention was implemented on mothers of preschoolers referring to the specialty dental clinic of Tehran School of Dentistry in 2019. The mothers were randomly allocated to the simple app or gamified app group. Before the intervention, all mothers filled out a questionnaire regarding oral health knowledge and practice, and their demographics were collected. The plaque index (PI) of children was also measured. The mothers filled out the same questionnaire 1 month after the intervention, and the PI of children was measured again. Paired t test and linear regression model were used for statistical analysis of the data. Results: Totally, 58 mother and child pairs entered the study; 40% of children were boys. The mean age of children was 4.7 ± 1.2 years. The mean knowledge score of mothers in the pretest was 10.5 and 11.3 in simple app and gamified app group, respectively, which changed to 13.1 and 14.3, respectively in the posttest. The mean practice score of mothers was 4.4 and 4.8 in simple app and gamified app groups, respectively in the pretest, which changed to 8.5 and 8, respectively in the posttest. The mean dental plaque index of children in the pretest was 0.8 and 1 in simple app and gamified app groups, respectively, which changed to 0.5 and 0.5, respectively in the posttest. Children had better Plaque control in gamified app group (P < 0.05). Conclusion: After 1 month, both apps effectively improved the oral-health knowledge and practice of mothers while oral hygiene as a result of plaque control was superior in children of mothers using the gamified app. Trial registration IRCT, IRCT20131102015238N2. Registered 24 February 2019—Retrospectively registered, https://fa.irct.ir/trial/36600. [ABSTRACT FROM AUTHOR]

Background: To assess the knowledge of and attitudes towards erosive tooth wear among dental, medical, and non-medical university students of two Chinese universities. Methods: A questionnaire containing 15 questions on knowledge of erosive tooth wear and 10 questions on attitudes towards erosive tooth wear was designed, and its psychometric properties (reliability and validity) were analysed in a pilot study (n = 120 students). The following 3 groups of university students (n = 635) were recruited based on a convenience sampling technique and were distributed the questionnaire via an online survey system: dental students (DSs), medical students (MSs), and non-medical students (NSs). Differences in the scores between groups and genders were analysed by one-way analysis of variance (ANOVA). The Pearson correlation coefficient was used to determine the association between the knowledge and attitude scores (P < 0.05). Results: The questionnaire was found to be reliable, valid and reproducible. A total of 435 students participated in this study (response rate: 69.6%). The knowledge score of the DSs (11.5 ± 3.4) was significantly higher than those of the NSs (5.5 ± 4.0) and MSs (6.1 ± 4.0) (P < 0.001). The attitude score of the DSs (45.2 ± 6.5) was significantly higher than those of the NSs (41.1 ± 6.9) and MSs (41.8 ± 6.4) (P < 0.001). The majority of DSs expressed attitudes that were more accurate and positive than those expressed by the other 2 groups. The attitude score was positively correlated with the knowledge score (r = 0.237, P < 0.001). Conclusions: Dental students had more accurate knowledge of and more positive attitudes towards erosive tooth wear than medical and non-medical students. In this population, a positive correlation was established between knowledge of and attitudes towards erosive tooth wear. [ABSTRACT FROM AUTHOR]

Background: Reducing alcohol related harms in Australian Defence Force (ADF) trainees has been identified as a priority, but there are few evidence-based prevention programs available for the military setting. The study aims to test whether the P.A.R.T.Y. program delivered in-hospital or on-base, can reduce harmful alcohol consumption among ADF trainees.Methods/design: The study is a 3-arm randomized controlled trial, involving 953 Royal Australian Navy trainees from a single base. Trainees, aged 18 to 30 years, will be randomly assigned to the study arms: i. in-hospital P.A.R.T.Y.; ii. On-base P.A.R.T.Y.; and iii.Control Group: All groups will receive the routine ADF annual alcohol awareness training. The primary outcome is the proportion of participants reporting an Alcohol Use Disorders Identification Test (AUDIT) score of 8 or above at 12 months' post-intervention. The secondary outcome is the number of alcohol related incidents reported to the Royal Australian Navy (RAN) in the 12 months' post-intervention.Discussion: This is the first trial of the use of the P.A.R.T.Y. program in the military. If the proposed intervention proves efficacious, it may be a useful program in the early education of RAN trainees.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001332617 , date of registration: 18/12/2014 'retrospectively registered'. [ABSTRACT FROM AUTHOR]

Background: Patients' treatment expectations are a key factor in psychotherapy. Several studies have linked higher expectations to better treatment success. Therefore, we want to evaluate the impact of a targeted video-based intervention on patients' expectations and the treatment success of inpatient rehabilitation.Methods/design: All patients who will be referred to inpatient psychosomatic rehabilitation in three clinics will receive a study flyer with information about how to log in to the study platform together with the usual clinic information leaflet. Patients will receive the study information and informed consent upon login and will be randomized into the intervention or the control group. The intervention group (n = 394) will get access to our virtual online clinic, containing several videos about inpatient rehabilitation, until their admission to inpatient rehabilitation. The control group (n = 394) will receive no special treatment preparation. Questionnaires will be given at study inclusion (T0), two weeks before admission to (T1), and at the end of (T2) inpatient rehabilitation. The primary outcome is the outcome expectancy measured with the Credibility Expectancy Questionnaire at T1. Secondary outcomes include treatment motivation, mental health, work ability, depression, anxiety, and satisfaction with and usage of the Internet platform.Discussion: We expect the intervention group to benefit from the additional preparation concerning their outcome expectancy. If successful, this approach could be used in the future to enhance the efficacy of inpatient rehabilitation.Trial Registration: ClinicalTrials.gov: NCT02532881 . Registered on 25 August 2015. [ABSTRACT FROM AUTHOR]

Background: While it is estimated that for every maternal death, 20-30 women suffer morbidity, these estimates are not based on standardized methods and measures. Lack of an agreed-upon definition, identification criteria, standardized assessment tools, and indicators has limited valid, routine, and comparable measurements of maternal morbidity. The World Health Organization (WHO) convened the Maternal Morbidity Working Group (MMWG) to develop standardized methods to improve estimates of maternal morbidity. To date, the MMWG has developed a definition and provided input into the development of a set of measurement tools. This protocol outlines the pilot test for measuring maternal morbidity in antenatal and postnatal clinical populations using these new tools. Methods: In each setting, the tools will be piloted on approximately 250 women receiving antenatal care (ANC) (at least 28 weeks pregnant) and 250 women receiving postpartum care (PPC) (at least 6 weeks postpartum). The tools will be administered by trained health care workers. Each tool has three modules as follows: 1. personal history -- socio-economic information, and risk-factors (such as violence and substance abuse) 2. patient symptoms -- WHO Disability Assessment Schedule (WHODAS) 12-item, and mental health questionnaires, General Anxiety Disorder, 7-item (GAD-7) and Personal Health Questionnaire, 9-item (PHQ-9) 3. physical examination -- signs, laboratory tests and results. Discussion: This pilot (planned for Jamaica, Kenya and Malawi) will allow for comparing the types of morbidities women experience between and across settings, and determine the feasibility, acceptability and utility of using a modified, streamlined tool for routine measurement and summary estimates of morbidity to inform resource allocation and service provision. As part of the post-2015 Sustainable Development Goals (SDGs) estimating and measuring maternal morbidity will be essential to ensure appropriate resources are allocated to address its impact and improve well-being. [ABSTRACT FROM AUTHOR]

Background: Osteoarthritis is the most common reason for pain in older adults, and the individual and economic burden of this disease is immense. The chronic character of osteoarthritis requires a long-term therapeutic treatment. In this regard life-style interventions such as physical exercises that can be carried out by the patient himself are recommended as first line treatment. There is evidence for the short-term benefit of exercise therapy in terms of pain reduction and physical functioning. Nonetheless research agendas highlight the need for multifaceted interventions that incorporate exercise strategies into patient care. Studies should be conducted with appropriate sample sizes and should allow statements on long-term effects as well as cost-utility and safety. These open questions are under the scope of this study.Methods/design: This is a controlled study in the context of health services research. The study population consists of n = 1400 subjects with hip or knee osteoarthritis. The intervention group will be recruited from participants of a country-wide health insurance offer for people with hip or knee osteoarthritis. Potential participants for the control group (ratio 10:1 (control vs. intervention) will be filtered out from the insurance data base according to pre-defined matching criteria and asked by letter for their participation. The final statistical twins from the responders (1:1) will be determined via propensity score matching. The progressive training intervention comprises 8 supervised group sessions, supplemented by home exercises (2/week over 11 weeks). Exercises include mobilization, strengthening and training of postural control. Primary outcomes are pain and function measured with the WOMAC Index immediately after the intervention period. Among other things, health related quality of life, self-efficacy, cost utility and safety will be evaluated as secondary outcomes. Participants will be followed up 6, 12 and 24 month after baseline.Discussion: Results of this trial will document the effects of clinical as well as economic outcomes in a regular health care setting on the basis of a large sample size. As such, results of this trial might have great impact on future implementations of group- and home-based exercises in hip or knee osteoarthritis.Trail Registration: German Clinical Trial Register DRKS00009251 . Registered 10 September 2015. [ABSTRACT FROM AUTHOR]

Background: Pelvic floor muscle training is effective and recommended as first-line therapy for female patients with stress urinary incontinence. However, standard pelvic floor physiotherapy concentrates on voluntary contractions even though the situations provoking stress urinary incontinence (for example, sneezing, coughing, running) require involuntary fast reflexive pelvic floor muscle contractions. Training procedures for involuntary reflexive muscle contractions are widely implemented in rehabilitation and sports but not yet in pelvic floor rehabilitation. Therefore, the research group developed a training protocol including standard physiotherapy and in addition focused on involuntary reflexive pelvic floor muscle contractions.Methods/design: The aim of the planned study is to compare this newly developed physiotherapy program (experimental group) and the standard physiotherapy program (control group) regarding their effect on stress urinary incontinence. The working hypothesis is that the experimental group focusing on involuntary reflexive muscle contractions will have a higher improvement of continence measured by the International Consultation on Incontinence Modular Questionnaire Urinary Incontinence (short form), and - regarding secondary and tertiary outcomes - higher pelvic floor muscle activity during stress urinary incontinence provoking activities, better pad-test results, higher quality of life scores (International Consultation on Incontinence Modular Questionnaire) and higher intravaginal muscle strength (digitally tested) from before to after the intervention phase. This study is designed as a prospective, triple-blinded (participant, investigator, outcome assessor), randomized controlled trial with two physiotherapy intervention groups with a 6-month follow-up including 48 stress urinary incontinent women per group. For both groups the intervention will last 16 weeks and will include 9 personal physiotherapy consultations and 78 short home training sessions (weeks 1-5 3x/week, 3x/day; weeks 6-16 3x/week, 1x/day). Thereafter both groups will continue with home training sessions (3x/week, 1x/day) until the 6-month follow-up. To compare the primary outcome, International Consultation on Incontinence Modular Questionnaire (short form) between and within the two groups at ten time points (before intervention, physiotherapy sessions 2-9, after intervention) ANOVA models for longitudinal data will be applied.Discussion: This study closes a gap, as involuntary reflexive pelvic floor muscle training has not yet been included in stress urinary incontinence physiotherapy, and if shown successful could be implemented in clinical practice immediately.Trial Registration: NCT02318251 ; 4 December 2014 First patient randomized: 11 March 2015. [ABSTRACT FROM AUTHOR]

Background: Starting with early identification of palliative care patients by general practitioners (GPs), the Care Pathway for Primary Palliative Care (CPPPC) is believed to help primary health care workers to deliver patient- and family-centered care in the last year of life. The care pathway has been pilot-tested, and will now be implemented in 5 Belgian regions: 2 Dutch-speaking regions, 2 French-speaking regions and the bilingual capital region of Brussels. The overall aim of the CPPPC is to provide better quality of primary palliative care, and in the end to reduce the hospital death rate. The aim of this article is to describe the quantitative design and innovative data collection strategy used in the evaluation of this complex intervention. Methods/Design: A quasi-experimental stepped wedge cluster design is set up with the 5 regions being 5 non-randomized clusters. The primary outcome is reduced hospital death rate per GPs' patient population. Secondary outcomes are increased death at home and health care consumption patterns suggesting high quality palliative care. Per research cluster, GPs will be recruited via convenience sampling. These GPs -volunteering to be involved will recruit people with reduced life expectancy and their informal care givers. Health care consumption data in the last year of life, available for all deceased people having lived in the research clusters in the study period, will be used for comparison between patient populations of participating GPs and patient populations of non-participating GPs. Description of baseline characteristics of participating GPs and patients and monitoring of the level of involvement by GPs, patients and informal care givers will happen through regular, privacy-secured web-surveys. Web-survey data and health consumption data are linked in a secure way, respecting Belgian privacy laws. Discussion: To evaluate this complex intervention, a quasi-experimental stepped wedge cluster design has been set up. Context characteristics and involvement level of participants are important parameters in evaluating complex interventions. It is possible to securely link survey data with health consumption data. By appealing to IT solutions we hope to be able to partly reduce respondent burden, a known problem in palliative care research. Trial registration: ClinicalTrials.gov Identifier: NCT02266069. [ABSTRACT FROM AUTHOR]

Background: Although detection of delirium using the current tools is excellent in research settings, in routine clinical practice, this is not the case. Together with nursing staff, we developed a screening tool (RADAR) to address certain limitations of existing tools, notably administration time, ease-of-use and generalizability. The purpose of this study was not only to evaluate the validity and reliability of RADAR but also to gauge its acceptability among the nursing staff in two different clinical settings. Methods: This was a validation study conducted on three units of an acute care hospital (medical, cardiology and coronary care) and five units of a long-term care facility. A total of 142 patients and 51 residents aged 65 and over, with or without dementia, participated in the study and 139 nurses were recruited and trained to use the RADAR tool. Data on each patient/resident was collected over a 12-hour period. The nursing staff and researchers administered RADAR during the scheduled distribution of medication. Researchers used the Confusion Assessment Method to determine the presence of delirium symptoms. Delirium itself was defined as meeting the criteria for DMS-IV-TR delirium. Inter-rater reliability, convergent, and concurrent validity of RADAR were assessed. At study end, 103 (74%) members of the nursing staff completed the RADAR feasibility and acceptability questionnaire. Results: Percentages of agreement between RADAR items that bedside nurses administered and those research assistants administered varied from 82% to 98%. When compared with DSM-IV-TR criterion-defined delirium, RADAR had a sensitivity of 73% and a specificity of 67%. Participating nursing staff took about seven seconds on average, to complete the tool and it was very well received (≥98%) overall. Conclusions: The RADAR tool proved to be efficient, reliable, sensitive and very well accepted by nursing staff. Consequently, it becomes an appropriate new option for delirium screening among older adults, with or without cognitive impairment, in both hospitals and nursing homes. Further projects are currently underway to validate the RADAR among middle-aged adults, as well as in newer clinical settings; home care, emergency department, medical intensive care unit, and palliative care. [ABSTRACT FROM AUTHOR]

Background Music therapy is one of the most frequently used complementary therapies in different palliative care settings. Despite its long tradition and high acceptance by other health-care professionals, evidence on the effectiveness of music therapy interventions for terminally ill patients is rare. Recent reviews and health-care reports consistently point out the need of music therapists to provide an evidence-based rationale for their clinical treatments in this field. Therefore, the present study evaluates the psychological and physiological response of palliative care patients to a standardized music therapy relaxation intervention in a randomized controlled trial. Methods/design A sample of 84 participants from a palliative care unit in Heidelberg is randomized to either two sessions of music therapy or two sessions of a verbal relaxation exercise, each lasting 30 minutes. The music therapy sessions consist of live played monochord music and a vocal improvisation, the control group uses a prerecorded excerpt from the mindfulness-based stress reduction program containing no musical elements. Outcome measures include self- report data on subjective relaxation, well-being, pain intensity, and quality of life, as well as continuous recording of heart rate variability and blood volume pulse as indicators of autonomous nervous system functioning. Discussion To our knowledge, this study is the first clinical trial in Europe and one of very few randomized controlled trials worldwide to systematically examine the effects of music therapy in palliative care. [ABSTRACT FROM AUTHOR]

Background: Health needs and access to health care is a huge challenge in developing countries, especially in some isolated indigenous communities. Amantani is an island located at 3854 m above sea level in Lake Titicaca, Peru. There is no official date on key local health needs and determinants, which precludes the prioritization and efficient implementation of health interventions. The objective of this study is to validate a health need assessment tool and ascertain the main health needs of the indigenous high-altitude population living on Amantani. Methods: We conducted a cross-sectional study to describe the health needs of the indigenous population of Amantani using a questionnaire based on the "Peruvian Demographic and Health Survey". The questionnaire underwent expert and field-work validation. We selected a random sample of the island residents using two-stage cluster sampling. We estimated the prevalence of key health needs and determinants, and evaluated their distribution by age, sex and education through prevalence ratio. All analyses accounted for the complex sampling design. Results: We surveyed 337 individuals (223 adults and 144 children) in 151 houses. The most frequent health needs were: (i) lack of access to medical screening for a)non-communicable diseases (> 63.0%) and b)eye problems (76.5%); and (ii) poor knowledge about communicable diseases (> 54.3%), cancer (71.4%) and contraception (> 32.9%). Smoking and alcohol use was more frequent in males (PR = 4.70 IC95%:1.41–15.63 and PR = 1.69 95% CI:1.27–2.25, respectively). People with higher education had more knowledge about TB/HIV and cancer prevention (p < 0.05). Regarding children's health, > 38% have never undergone eye or dental examination. Corporal punishment and physical bullying at school in the last month were relatively common (23 and 33%, respectively). Conclusion: The main health needs in Amantani are related to poor healthcare access and lack of awareness of disease prevention. Our findings can be used to develop and implement efficient health interventions to improve the health and quality of life of indigenous populations living in the islands in Southern Peru/Northern Bolivia. [ABSTRACT FROM AUTHOR]