bluuebunny/crossref_metadata_2025 huggingface dataset:
Overcoming challenges in implementing the WHO Surgical Safety Checklist: lessons learnt from using a checklist training course to facilitate rapid scale up in Madagascar
Authors: Close Kristin L , Baxter Linden S , Ravelojaona Vaonandianina A , Rakotoarison Hasiniaina N , Bruno Emily , Herbert Alison , Andean Vanessa , Callahan James , Andriamanjato Hery H , White Michelle C
Published: September 2017

The WHO Surgical Safety Checklist was launched in 2009, and appropriate use reduces mortality, surgical site infections and complications after surgery by up to 50%. Implementation across low-income and middle-income countries has been slow; published evidence is restricted to reports from a few single institutions, and significant challenges to successful implementation have been identified and presented. The Mercy Ships Medical Capacity Building team developed a multidisciplinary 3-day Surgical Safety Checklist training programme designed for rapid wide-scale implementation in all regional referral hospitals in Madagascar. Particular attention was given to addressing previously reported challenges to implementation. We taught 427 participants in 21 hospitals; at 3–4 months postcourse, we collected surveys from 183 participants in 20 hospitals and conducted one focus group per hospital. We used a concurrent embedded approach in this mixed-methods design to evaluate participants’ experiences and behavioural change as a result of the training programme. Quantitative and qualitative data were analysed using descriptive statistics and inductive thematic analysis, respectively. This analysis paper describes our field experiences and aims to report participants’ responses to the training course, identify further challenges to implementation and describe the lessons learnt. Recommendations are given for stakeholders seeking widespread rapid scale up of quality improvement initiatives to promote surgical safety worldwide.
Mental well-being of patients from ethnic minority groups during critical care: a qualitative ethnographic study
Authors: Van Keer Rose Lima , Deschepper Reginald , Huyghens Luc , Bilsen Johan
Published: September 2017

Objectives

To investigate the state of the mental well-being of patients from ethnic minority groups and possible related risk factors for the development of mental health problems among these patients during critical medical situations in hospital.

Design

Qualitative ethnographic design.

Setting

Oneintensive care unit (ICU) of a multiethnic urban hospital in Belgium.

Participants

84 ICU staff members, 10 patients from ethnic-minority groups and their visiting family members.

Results

Patients had several human basic needs for which they could not sufficiently turn to anybody, neither to their healthcare professionals, nor to their relatives nor to other patients. These needs included the need for social contact, the need to increase comfort and alleviate pain, the need to express desperation and participate in end-of-life decision making. Three interrelated risk factors for the development of mental health problems among the patients included were identified: First, healthcare professionals’ mainly biomedical care approach (eg, focus on curing the patient, limited psychosocial support), second, the ICU context (eg, time pressure, uncertainty, regulatory frameworks) and third, patients’ different ethnocultural background (eg, religious and phenotypical differences).

Conclusions

The mental state of patients from ethnic minority groups during critical care is characterised by extreme emotional loneliness. It is important that staff should identify and meet patients’ unique basic needs in good time with regard to their mental well-being, taking into account important threats related to their own mainly biomedical approach to care, the ICU’s structural context as well as the patients’ different ethnocultural background.
A cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the GoActive intervention to increase physical activity among adolescents aged 13–14 years
Authors: Brown Helen Elizabeth , Whittle Fiona , Jong Stephanie T , Croxson Caroline , Sharp Stephen J , Wilkinson Paul , Wilson Edward CF , van Sluijs Esther MF , Vignoles Anna , Corder Kirsten
Published: September 2017

Introduction

Adolescent physical activity promotion is rarely effective, despite adolescence being critical for preventing physical activity decline. Low adolescent physical activity is likely to last into adulthood, increasing health risks. The Get Others Active (GoActive) intervention is evidence-based and was developed iteratively with adolescents and teachers. This intervention aims to increase physical activity through increased peer support, self-efficacy, group cohesion, self-esteem and friendship quality, and is implemented using a tiered-leadership system. We previously established feasibility in one school and conducted a pilot randomised controlled trial (RCT) in three schools.

Methods and analysis

We will conduct a school-based cluster RCT (CRCT) in 16 secondary schools targeting all year 9 students (n=2400). In eight schools, GoActive will run for two terms: weekly facilitation support from a council-funded intervention facilitator will be offered in term 1, with more distant support in term 2. Tutor groups choose two weekly activities, encouraged by older adolescent mentors and weekly peer leaders. Students gain points for trying new activities; points are entered into a between-class competition. Outcomes will be assessed at baseline, interim (week 6), postintervention (week 14–16) and 10-month follow-up (main outcome). The primary outcome will be change from baseline in daily accelerometer-assessed moderate-to-vigorous physical activity. Secondary outcomes include accelerometer-assessed activity intensities on weekdays/weekends; self-reported physical activity and psychosocial outcomes; cost-effectiveness and cost-utility analyses; mixed-methods process evaluation integrating information from focus groups and participation logs/questionnaires.

Ethics and dissemination

Ethical approval for the conduct of the study was gained from the University of Cambridge Psychology Research Ethics Committee. Given the lack of rigorously evaluated interventions, and the inclusion of objective measurement of physical activity, long-term follow-up and testing of causal pathways, the results of a CRCT of the effectiveness and cost-effectiveness of GoActive are expected to add substantially to the limited evidence on adolescent physical activity promotion. Workshops will be held with key stakeholders including students, parents, teachers, school governors and government representatives to discuss plans for wider dissemination of the intervention.

Trial registration number

ISRCTN31583496.
Urine and serum midkine levels in an Australian chronic kidney disease clinic population: an observational study
Authors: Campbell Victoria K , Anstey Chris M , Gately Ryan P , Comeau Drew C , Clark Carolyn J , Noble Euan P , Mahadevan Kumar , Hollett Peter R , Pollock Andrea J , Hall Sharron T , Jones Darren R , Burg Dominic , Gray Nicholas A
Published: September 2017

Background and objectives

The cytokine midkine (MK) is pathologically implicated in progressive chronic kidney disease (CKD) and its systemic consequences and has potential as both a biomarker and therapeutic target. To date, there are no published data on MK levels in patients with different stages of CKD. This study aims to quantify MK levels in patients with CKD and to identify any correlation with CKD stage, cause, progression, comorbid disease or prescribed medication.

Methods

In this observational, single-centre study, demographic data were collected, and serum and urine assayed from 197 patients with CKD and 19 healthy volunteers in an outpatient setting.

Results

The median serum and urine MK level in volunteers was 754 pg/mL (IQR: 554–1025) and 239 pg/mL (IQR: 154–568), respectively. Compared with serum MK in stage 1 CKD (660 pg/mL, IQR: 417–893), serum MK increased in stage 3 (1878 pg/mL, IQR: 1188–2756; p<0.001), 4 (2768 pg/mL, IQR: 2065–4735; p<0.001) and 5 (4816 pg/mL, IQ: 37477807; p<0.001). Urine MK levels increased from stage 1 CKD (343 pg/mL, IQR: 147–437) to stage 3 (1007 pg/mL, IQR: 465–2766; p=0.07), 4 (2961 pg/mL, IQR: 1368–5686; p=0.005) and 5 (6722 pg/mL, IQR: 3796–10 060; p=0.001). Fractional MK excretion (FeMK) increased from stage 1 CKD (0.159, IQR: 0.145–0.299) to stage 3 (1.024, IQR: 0.451–1.886, p=0.047), 4 (3.39, IQR: 2.10–5.82, p=0.004) and 5 (11.95, IQR: 5.36–24.41, p<0.001). When adjusted for estimated glomerular filtration rate, neither serum nor urine MK correlated with primary CKD diagnosis or CKD progression (small sample). There was a positive correlation between protein:creatinine ratio and FeMK (p=0.003). Angiotensin blockade (adjusted for proteinuria) was associated with lower urine MK (p=0.018) and FeMK (p=0.025).

Conclusion

MK levels sequentially rise with CKD stage beyond stage 2, and our data support existing animal evidence for an MK/renin angiotensin-system/proteinuria relationship. To what extent this is related to renal clearance versus pathology, or the consequences of chronically elevated MK levels requires further exploration.
Irradiation enhanced risks of hospitalised pneumonopathy in lung cancer patients: a population-based surgical cohort study
Authors: Hung Shih-Kai , Chen Yi-Chun , Chiou Wen-Yen , Lai Chun-Liang , Lee Moon-Sing , Lo Yuan-Chen , Chen Liang-Cheng , Huang Li-Wen , Chien Nai-Chuan , Li Szu-Chi , Liu Dai-Wei , Hsu Feng-Chun , Tsai Shiang-Jiun , Chan Michael WY , Lin Hon-Yi
Published: September 2017

Objective

Pulmonary radiotherapy has been reported to increase a risk of pneumonopathy, including pneumonitis and secondary pneumonia, however evidence from population-based studies is lacking. The present study intended to explore whether postoperative irradiation increases occurrence of severe pneumonopathy in lung cancer patients.

Design, setting and participants

The nationwide population-based study analysed the Taiwan National Health Insurance Research Database (covered >99% of Taiwanese) in a real-world setting. From 2000 to 2010, 4335 newly diagnosed lung cancer patients were allocated into two groups: surgery-RT (n=867) and surgery-alone (n=3468). With a ratio of 1:4, propensity score was used to match 11 baseline factors to balance groups.

Interventions/exposure(s)

Irradiation was delivered to bronchial stump and mediastinum according to peer-audited guidelines.

Outcome(s)/measure(s)

Hospitalised pneumonia/pneumonitis-free survival was the primary end point. Risk factors and hazard effects were secondary measures.

Results

Multivariable analysis identified five independent risk factors for hospitalised pneumonopathy: elderly (>65 years), male, irradiation, chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD). Compared with surgery-alone, a higher risk of hospitalised pneumonopathy was found in surgery-RT patients (HR, 2.20; 95% CI, 1.93–2.51; 2-year hospitalised pneumonia/pneumonitis-free survival, 85.2% vs 69.0%; both p<0.0001), especially in elderly males with COPD and CKD (HR, 13.74; 95% CI, 6.61–28.53; p<0.0001). Unexpectedly, we observed a higher risk of hospitalised pneumonopathy in younger irradiated-CKD patients (HR, 13.07; 95% CI, 5.71–29.94; p<0.0001) than that of elderly irradiated-CKD patients (HR, 4.82; 95% CI, 2.88–8.08; p<0.0001).

Conclusions

A high risk of hospitalised pneumonopathy is observed in irradiated patients, especially in elderly males with COPD and CKD. For these patients, close clinical surveillance and aggressive pneumonia/pneumonitis prevention should be considered. Further investigations are required to define underlying biological mechanisms, especially for younger CKD patients.
Simplification of the Finnegan Neonatal Abstinence Scoring System: retrospective study of two institutions in the USA
Authors: Gomez Pomar Enrique , Finnegan Loretta P , Devlin Lori , Bada Henrietta , Concina Vanessa A , Ibonia Katrina T , Westgate Philip M
Published: September 2017

Objective

To develop a simplified Finnegan Neonatal Abstinence Scoring System (sFNAS) that will highly correlate with scores ≥8 and ≥12 in infants being assessed with the FNAS.

Design, setting and participants

This is a retrospective analysis involving 367 patients admitted to two level IV neonatal intensive care units with a total of 40 294 observations. Inclusion criteria included neonates with gestational age ≥37 0/7 weeks, who are being assessed for neonatal abstinence syndrome (NAS) using the FNAS. Infants with a gestational age <37 weeks were excluded.

Methods

A linear regression model based on the original FNAS data from one institution was developed to determine optimal values for each item in the sFNAS. A backward elimination approach was used, removing the items that contributed least to the Pearson’s correlation. The sFNAS was then cross-validated with data from a second institution.

Results

Pearson’s correlation between the proposed sFNAS and the FNAS was 0.914. The optimal treatment cut-off values for the sFNAS were 6 and 10 to predict FNAS scores ≥8 and ≥12, respectively. The sensitivity and specificity of these cut-off values to detect FNAS scores ≥8 and ≥12 were 0.888 and 0.883 for a cut-off of 6, and 0.637 and 0.992 for a cut-off of 10, respectively. The sFNAS cross-validation resulted in a Pearson’s correlation of 0.908, sensitivity and specificity of 0.860 and 0.873 for a cut-off of 6, and 0.525 and 0.986 for a cut-off of 10, respectively.

Conclusion

The sFNAS has a high statistical correlation with the FNAS, and it is cross-validated for the assessment of infants with NAS. It has excellent specificity and negative predictive value for identifying infants with FNAS scores ≥8 and ≥12.
How are decisions made in cancer care? A qualitative study using participant observation of current practice
Authors: Hahlweg Pola , Härter Martin , Nestoriuc Yvonne , Scholl Isabelle
Published: September 2017

Objectives

Shared decision-making has continuously gained importance over the last years. However, few studies have investigated the current state of shared decision-making implementation in routine cancer care. This study aimed to investigate how treatment decisions are made in routine cancer care and to explore barriers and facilitators to shared decision-making using an observational approach (three independent observers). Furthermore, the study aimed to extend the understanding of current decision-making processes beyond the dyadic physician–patient interaction.

Design

Cross-sectional qualitative study using participant observation with semistructured field notes, which were analysed using qualitative content analysis as described by Hsieh and Shannon.

Setting and participants

Field notes from participant observations were collected at n=54 outpatient consultations and during two 1-week-long observations at two inpatient wards in different clinics of one comprehensive cancer centre in Germany.

Results

Most of the time, either one physician alone or a group of physicians made the treatment decisions. Patients were seldom actively involved. Patients who were ‘active’ (ie, asked questions, demanded participation, opposed treatment recommendations) facilitated shared decision-making. Time pressure, frequent alternation of responsible physicians and poor coordination of care were the main observed barriers for shared decision-making. We found high variation in decision-making behaviour between different physicians as well as the same physician with different patients.

Conclusion

Most of the time physicians made the treatment decisions. Shared decision-making was very rarely implemented in current routine cancer care. The entire decision-making process was not observed to follow the principles of shared decision-making. However, some aspects of shared decision-making were occasionally incorporated. Individual as well as organisational factors were found to influence the degree of shared decision-making. If future routine cancer care wishes to follow the principles of shared decision-making, strategies are needed to foster shared decision-making in routine cancer care.
Interactions between physicians and the pharmaceutical industry generally and sales representatives specifically and their association with physicians’ attitudes and prescribing habits: a systematic review
Authors: Fickweiler Freek , Fickweiler Ward , Urbach Ewout
Published: September 2017

Objectives

The objective of this review is to explore interactions between physicians and the pharmaceutical industry including sales representatives and their impact on physicians’ attitude and prescribing habits.

Data sources

PubMed, Embase, Cochrane Library and Google scholar electronic databases were searched from 1992 to August 2016 using free-text words and medical subject headings relevant to the topic.

Study selection

Studies included cross-sectional studies, cohort studies, randomised trials and survey designs. Studies with narrative reviews, case reports, opinion polls and letters to the editor were excluded from data synthesis.

Data extraction

Two reviewers independently extracted the data. Data on study design, study year, country, participant characteristics, setting and number of participants were collected.

Data synthesis

Pharmaceutical industry and pharmaceutical sales representative (PSR) interactions influence physicians’ attitudes and their prescribing behaviour and increase the number of formulary addition requests for the company’s drug.

Conclusion

Physician–pharmaceutical industry and its sales representative’s interactions and acceptance of gifts from the company’s PSRs have been found to affect physicians’ prescribing behaviour and are likely to contribute to irrational prescribing of the company’s drug. Therefore, intervention in the form of policy implementation and education about the implications of these interactions is needed.
Does funded research reflect the priorities of people living with type 1 diabetes? A secondary analysis of research questions
Authors: Boddy Kate , Cowan Katherine , Gibson Andy , Britten Nicky
Published: September 2017

Objectives

This study explored the divergence and convergence between funded research about type 1 diabetes and the research agenda of people living with the condition and their carers.

Design, method, setting

A secondary analysis was undertaken of existing data from two UK organisations who regularly work with patients and carers to identify research priorities. The research ideas of people with diabetes were identified in two ways: in 15 research question generation workshops involving approximately 100 patients and carers, and in a James Lind Alliance Type 1 Diabetes Priority Setting Partnership with approximately 580 patients, carers and clinicians (clinician question submissions were excluded from analysis). A total of 859 individual research questions were collected from patients and carers. Diabetes research funding activity was identified through extensive online searches which provided a total of 172 relevant research projects for analysis.

Results

The data were thematically analysed and areas of priority for research identified and compared between the patient and funded research agendas. The overall finding of this study is that there is substantial convergence between the two research agendas, alongside some important areas of divergence. The key areas of divergence were found in care delivery, injection issues, psychosocial impacts and women’s health. We also demonstrate how an apparently convergent priority can host significant differences in emphasis between patient-generated and funded research agendas.

Conclusions

We offer a comparison of a funded research agenda with one that has been derived directly from people with type 1 diabetes without initial framing by researchers. This provided a rare opportunity to explore the viewpoints of the end-users of research and compare them to realised research as determined by researchers and research organisations.
Efficacy and safety of So-Cheong-Ryong-Tang in treatment of perennial allergic rhinitis: study protocol for a double-blind, randomised, parallel-group, multicentre trial
Authors: Kim Min-Hee , Ko Youme , Ahn Jin-Hyang , Yun Younghee , Yun Mi-Na , Ko Seong-Gyu , Choi Inhwa
Published: September 2017

Introduction

So-Cheong-Ryong-Tang (SCRT) is a herbal medicine widely used in traditional medicine for treating allergic rhinitis (AR). In animal studies, SCRT has suppressed the progression of AR. The main purpose of this study is to assess the efficacy and safety of the SCRT for the treatment of perennial allergic rhinitis (PAR) and discover the underlying mechanisms resulting in anti-inflammatory effects in humans.

Methods and analysis

We will conduct a double-blind, randomised, placebo-controlled, parallel-group, multicentre trial of Korean adults with PAR. For the study, 156 subjects with PAR will be recruited. The trial will consist of a 4-week oral administration of SCRT or placebo with two visits at 2-week intervals and an 8-week follow-up period with two visits at 4-week intervals. The primary outcome is a change in the total nasal symptoms score. The secondary outcomes include changes in the Rhinoconjunctivitis Quality of Life Questionnaire score, total serum IgE and cytokines levels.

Ethics and dissemination

This study was approved by the Institutional Review Board at each research centre (name of each centres and approval numbers): Kyung Hee University Hospital at Gangdong (KHNMC-OH-IRB 2015-04-009), Kyung Hee University Medical Centre (KOMCIRB-160321-HRBR-011), Pusan National University Hospital (2016–004), Dongguk University Medical Centre (2016–03) and Semyung University hospital (2016–01). This result will be published in a peer-reviewed journal.

Trial registration number

NCT03009136; Pre-results.
Systematic review of prognostic prediction models for acute kidney injury (AKI) in general hospital populations
Authors: Hodgson Luke Eliot , Sarnowski Alexander , Roderick Paul J , Dimitrov Borislav D , Venn Richard M , Forni Lui G
Published: September 2017

Objective

Critically appraise prediction models for hospital-acquired acute kidney injury (HA-AKI) in general populations.

Design

Systematic review.

Data sources

Medline, Embase and Web of Science until November 2016.

Eligibility

Studies describing development of a multivariable model for predicting HA-AKI in non-specialised adult hospital populations. Published guidance followed for data extraction reporting and appraisal.

Results

14 046 references were screened. Of 53 HA-AKI prediction models, 11 met inclusion criteria (general medicine and/or surgery populations, 474 478 patient episodes) and five externally validated. The most common predictors were age (n=9 models), diabetes (5), admission serum creatinine (SCr) (5), chronic kidney disease (CKD) (4), drugs (diuretics (4) and/or ACE inhibitors/angiotensin-receptor blockers (3)), bicarbonate and heart failure (4 models each). Heterogeneity was identified for outcome definition. Deficiencies in reporting included handling of predictors, missing data and sample size. Admission SCr was frequently taken to represent baseline renal function. Most models were considered at high risk of bias. Area under the receiver operating characteristic curves to predict HA-AKI ranged 0.71–0.80 in derivation (reported in 8/11 studies), 0.66–0.80 for internal validation studies (n=7) and 0.65–0.71 in five external validations. For calibration, the Hosmer-Lemeshow test or a calibration plot was provided in 4/11 derivations, 3/11 internal and 3/5 external validations. A minority of the models allow easy bedside calculation and potential electronic automation. No impact analysis studies were found.

Conclusions

AKI prediction models may help address shortcomings in risk assessment; however, in general hospital populations, few have external validation. Similar predictors reflect an elderly demographic with chronic comorbidities. Reporting deficiencies mirrors prediction research more broadly, with handling of SCr (baseline function and use as a predictor) a concern. Future research should focus on validation, exploration of electronic linkage and impact analysis. The latter could combine a prediction model with AKI alerting to address prevention and early recognition of evolving AKI.
Cohort profile: The Swedish National Register of Urinary Bladder Cancer (SNRUBC) and the Bladder Cancer Data Base Sweden (BladderBaSe)
Authors: Häggström Christel , Liedberg Fredrik , Hagberg Oskar , Aljabery Firas , Ströck Viveka , Hosseini Abolfazl , Gårdmark Truls , Sherif Amir , Malmström Per-Uno , Garmo Hans , Jahnson Staffan , Holmberg Lars
Published: September 2017

Purpose

To monitor the quality of bladder cancer care, the Swedish National Register of Urinary Bladder Cancer (SNRUBC) was initiated in 1997. During 2015, in order to study trends in incidence, effects of treatment and survival of men and women with bladder cancer, we linked the SNRUBC to other national healthcare and demographic registers and constructed the Bladder Cancer Data Base Sweden (BladderBaSe).

Participants

The SNRUBC is a nationwide register with detailed information on 97% of bladder cancer cases in Sweden as compared with the Swedish Cancer Register. Participants in the SNRUBC have registered data on tumour characteristics at diagnosis, and for 98% of these treatment data have been captured. From 2009, the SNRUBC holds data on 88% of eligible participants for follow-up 5 years after diagnosis of non-muscle invasive bladder cancer, and from 2011, data on surgery details and complications for 85% of participants treated with radical cystectomy. The BladderBaSe includes all data in the SNRUBC from 1997 to 2014, and additional covariates and follow-up data from linked national register sources on comorbidity, socioeconomic factors, detailed information on readmissions and treatment side effects, and causes of death.

Findings to date

Studies based on data in the SNRUBC have shown inequalities in survival and treatment indication by gender, regions and hospital volume. The BladderBaSe includes 38 658 participants registered in SNRUBC with bladder cancer diagnosed from 1 January 1997 to 31 December 2014. The BladderBaSe initiators are currently in collaboration with researchers from the SNRUBC investigating different aspects of bladder cancer survival.

Future plans

The SNRUBC and the BladderBaSe project are open for collaborations with national and international research teams. Collaborators can submit proposals for studies and study files can be uploaded to servers for remote access and analysis. For more information, please contact the corresponding author.
Thiazide diuretics and the risk of hip fracture after stroke: a population-based propensity-matched cohort study using Taiwan’s National Health Insurance Research Database
Authors: Lin Shu-Man , Yang Shih-Hsien , Cheng Hung-Yu , Liang Chung-Chao , Huang Huei-Kai
Published: September 2017

Objectives

This study aimed to investigate the association between thiazide use and the risk of hip fracture after stroke.

Setting

A population-based, propensity-matched cohort study was conducted on the basis of Taiwan’s National Health Insurance Research Database.

Participants

Patients with newly diagnosed ischaemic stroke between 2000 and 2011 were included. After propensity score matching, 7470 patients were included, of whom 3735 received thiazides and 3735 did not.

Outcome measures

HRs for developing hip fractures within 2 years after stroke were calculated using Cox proportional hazards regression model with adjustments for sociodemographic and coexisting medical conditions.

Results

Overall, patients using thiazides after stroke had a lower risk of hip fracture than those not using thiazides (8.5 vs 13.9 per 1000 person-years, adjusted HR=0.64, 95% CI 0.46 to 0.89, p=0.007). Further sensitivity analysis based on the duration of thiazide use revealed that the risk of hip fracture tended to decrease as the duration of exposure of thiazides increased. However, the effect was significant only in patients with long-term use of thiazides (using thiazides for >365 days within 2 years after stroke), with a 59% reduction in the risk of hip fracture when compared with patients not using thiazide (adjusted HR=0.41, 95% CI 0.22 to 0.79, p=0.008).

Conclusions

The long-term use of thiazides is associated with a decreased risk of hip fracture after stroke.
Presentation approaches for enhancing interpretability of patient-reported outcomes (PROs) in meta-analysis: a protocol for a systematic survey of Cochrane reviews
Authors: Devji Tahira , Johnston Bradley C , Patrick Donald L , Bhandari Mohit , Thabane Lehana , Guyatt Gordon H
Published: September 2017

Introduction

Meta-analyses of clinical trials often provide sufficient information for decision-makers to evaluate whether chance can explain apparent differences between interventions. Interpretation of the magnitude and importance of treatment effects beyond statistical significance can, however, be challenging, particularly for patient-reported outcomes (PROs) measured using questionnaires with which clinicians have limited familiarity. The objectives of our study are to systematically evaluate Cochrane systematic review authors’ approaches to calculation, reporting and interpretation of pooled estimates of patient-reported outcome measures (PROMs) in meta-analyses.

Methods and analysis

We will conduct a methodological survey of a random sample of Cochrane systematic reviews published from 1 January 2015 to 1 April 2017 that report at least one statistically significant pooled result for at least one PRO in the abstract. Author pairs will independently review all titles, abstracts and full texts identified by the literature search, and they will extract data using a standardised data extraction form. We will extract the following: year of publication, number of included trials, number of included participants, clinical area, type of intervention(s) and control(s), type of meta-analysis and use of the Grading of Recommendations, Assessment, Development and Evaluation approach to rate the quality of evidence, as well as information regarding the characteristics of PROMs, calculation and presentation of PROM effect estimates and interpretation of PROM effect estimates. We will document and summarise the methods used for the analysis, reporting and interpretation of each summary effect measure. We will summarise categorical variables with frequencies and percentages and continuous outcomes as means and/or medians and associated measures of dispersion.

Ethics and dissemination

Ethics approval for this study is not required. We will disseminate the results of this review in peer-reviewed publications and conference presentations.
Clinical examination, critical care ultrasonography and outcomes in the critically ill: cohort profile of the Simple Intensive Care Studies-I
Authors: Hiemstra Bart , Eck Ruben J , Koster Geert , Wetterslev JÃ¸rn , Perner Anders , PettilÃ¤ Ville , Snieder Harold , Hummel Yoran M , Wiersema Renske , de Smet Anne Marie G A , Keus Frederik , van der Horst Iwan C C
Published: September 2017

Purpose

In the Simple Intensive Care Studies-I (SICS-I), we aim to unravel the value of clinical and haemodynamic variables obtained by physical examination and critical care ultrasound (CCUS) that currently guide daily practice in critically ill patients. We intend to (1) measure all available clinical and haemodynamic variables, (2) train novices in obtaining values for advanced variables based on CCUS in the intensive care unit (ICU) and (3) create an infrastructure for a registry with the flexibility of temporarily incorporating specific (haemodynamic) research questions and variables. The overall purpose is to investigate the diagnostic and prognostic value of clinical and haemodynamic variables.

Participants

The SICS-I includes all patients acutely admitted to the ICU of a tertiary teaching hospital in the Netherlands with an ICU stay expected to last beyond 24 hours. Inclusion started on 27 March 2015.

Findings to date

On 31 December 2016, 791 eligible patients fulfilled our inclusion criteria of whom 704 were included. So far 11 substudies with additional variables have been designed, of which six were feasible to implement in the basic study, and two are planned and awaiting initiation. All researchers received focused training for obtaining specific CCUS images. An independent Core laboratory judged that 632 patients had CCUS images of sufficient quality.

Future plans

We intend to optimise the set of variables for assessment of the haemodynamic status of the critically ill patient used for guiding diagnostics, prognosis and interventions. Repeated evaluations of these sets of variables are needed for continuous improvement of the diagnostic and prognostic models. Future plans include: (1) more advanced imaging; (2) repeated clinical and haemodynamic measurements; (3) expansion of the registry to other departments or centres; and (4) exploring possibilities of integration of a randomised clinical trial superimposed on the registry.

Study registration number

NCT02912624; Pre-results.
Cross-sector user and provider perceptions on experiences of shared-care clozapine: a qualitative study
Authors: Sowerby Camilla , Taylor Denise
Published: September 2017

Objectives

(1) To explore individual perceptions on experiences of people receiving and/or delivering a shared-care clozapine serviceand (2) to gain an understanding of effectiveness and acceptability of shared-care clozapine.

Design

Interpretative phenomenological analysis guided the delivery and analysis of a semistructured interview and focus group study designed to explore participant experience of shared-care clozapine. Ethical approval 13/EM/0286 was gained in July 2013 from East Midlands—Nottingham 1 REC.

Participants

Eight stakeholder groups from Adult and Forensic Mental Health involved in shared-care clozapine provision delivered in primary care were identified for recruitment from one mental health trust in England (six different groups of healthcare professionals (HCPs), clozapine service users (CSUs) and their carers). To be eligible for recruitment, all potential participants had to be either providing, receiving or the carer of a person receiving clozapine by shared care.

Results

32 HCPs and 6 CSUs were recruited and 14 interviews and 6 participant homogenous focus groups were run. Four shared superordinate themes were identified: Clozapine Process, The Sharing of Care, The Provision of Care and Multi-professional Relationships. Differences between Adult and Forensic engagement in shared care were noted and both HCP and CSU relationships were mapped to the Wish conceptual framework of relationships to provide insight into how shared-care clozapine can provide a mechanism for provision of person-centred care, which was present in the Forensic HCP–CSU but not General Adult HCP–CSU relationship.

Conclusions

The Forensic HCP/CSU relationship demonstrated how cross-sector working through shared-care clozapine can provide a mechanism for provision of person-centred care by enabling a person-centred focus to care delivery which supported CSUs to live as independently as possible. Person-centred care demonstrably improves patient care outcomes and wider implementation of shared-care clozapine could provide greater integration of people with serious mental illness and reduce stigma within the community while improving patient outcomes.
Development of a physical activity monitoring tool for Thai medical schools: a protocol for a mixed methods study
Authors: Wattanapisit Apichai , Vijitpongjinda Surasak , Saengow Udomsak , Amaek Waluka , Thanamee Sanhapan , Petchuay Prachyapan
Published: September 2017

Introduction

Physical activity (PA) is important in promoting health, as well as in the treatment and prevention of diseases. However, insufficient PA is still a global health problem and it is also a problem in medical schools. PA training in medical curricula is still sparse or non-existent. There is a need for a comprehensive understanding of the extent of PA in medical schools through several indicators, including people, places and policies. This study includes a survey of the PA prevalence in a medical school and development of a tool, the Medical School Physical Activity Report Card (MSPARC), which will contain concise and understandable infographics and information for exploring, monitoring and reporting information relating to PA prevalence.

Methods and analysis

This mixed methods study will run from January to September 2017. We will involve the School of Medicine, Walailak University, Thailand, and its medical students (n=285). Data collection will consist of both primary and secondary data, divided into four parts: general information, people, places and policies. We will investigate the PA metrics about (1) people: the prevalence of PA and sedentary behaviours; (2) place: the quality and accessibility of walkable neighbourhoods, bicycle facilities and recreational areas; and (3) policy: PA promotion programmes for medical students, education metrics and investments related to PA. The MSPARC will be developed using simple symbols, infographics and short texts to evaluate the PA metrics of the medical school.

Ethics and dissemination

This study has been approved by the Human Research Ethics Committee of Walailak University (protocol number: WUEC-16-005-01). Findings will be published in peer-reviewed journals and presented at national or international conferences. The MSPARC and full report will be disseminated to relevant stakeholders, policymakers, staff and clients.
Influence of allocation concealment and intention-to-treat analysis on treatment effects of physical therapy interventions in low back pain randomised controlled trials: a protocol of a meta-epidemiological study
Authors: Almeida Matheus Oliveira , Saragiotto Bruno T , Maher Chris G , Pena Costa Leonardo Oliveira
Published: September 2017

Introduction

Meta-epidemiological studies examining the influence of methodological characteristics, such as allocation concealment and intention-to-treat analysis have been performed in a large number of healthcare areas. However, there are no studies investigating these characteristics in physical therapy interventions for patients with low back pain. The aim of this study is to investigate the influence of allocation concealment and the use of intention-to-treat analysis on estimates of treatment effects of physical therapy interventions in low back pain clinical trials.

Methods and analysis

Searches on PubMed, Embase, Cochrane Database of Systematic Reviews, Physiotherapy Evidence Database (PEDro) and CINAHL databases will be performed. We will search for systematic reviews that include a meta-analysis of randomised controlled trials that compared physical therapy interventions in patients with low back pain with placebo or no intervention, and have pain intensity or disability as the primary outcomes. Information about selection (allocation concealment) and attrition bias (intention-to-treat analysis) will be extracted from the PEDro database for each included trial. Information about bibliographic data, study characteristics, participants’ characteristics and study results will be extracted. A random-effects model will be used to provide separate estimates of treatment effects for trials with and without allocation concealment and with and without intention-to-treat analysis (eg, four estimates). A meta-regression will be performed to measure the association between methodological features and treatment effects from each trial. The dependent variable will be the treatment effect (the mean between-group differences) for the primary outcomes (pain or disability), while the independent variables will be the methodological features of interest (allocation concealment and intention-to-treat analysis). Other covariates will include sample size and sequence generation.

Ethics and dissemination

No ethical approval will be required for this study. The study findings will be published in a peer-reviewed journal and presented at international conferences.

Registration number

International Prospective Register of Systematic Reviews (CRD42016052347).
Association between vomiting in the first trimester and preterm birth: a retrospective birth cohort study in Wuhan, China
Authors: Hu Ronghua , Chen Yawen , Zhang Yiming , Qian Zhengmin , Liu Yan , Vaughn Michael G , Xu Shunqing , Zheng Tongzhang , Liu Mingzhu , Zhang Bin
Published: September 2017

Objective

Although vomiting in the first trimester has been reported to be associated with preterm birth (PTB), findings supporting this association remain inconsistent. Our aim was to assess the association between vomiting and PTB, as well as evaluate if the association is modified by pre-pregnancy body mass index (BMI).

Design

A retrospective cohort study.

Setting

Wuhan, a central city of China.

Participants

A total of 317 463 pregnant women who had a live, singleton newborn from 1 January 2010 to 23 May 2016 were enrolled in our study.

Main outcome measure

PTB was defined as gestational age <37 gestational weeks. Gestational age was calculated using reports from mothers based on the first day of their last menstrual period. An ultrasound was routinely used to determine gestational age before 12 gestational weeks.

Results

Of the 317 463 pregnant women, 29.88% (94 857) experienced vomiting in the first trimester and 5.00% (15 889) experienced a PTB. Vomiting in the first trimester increased the risk for PTB and the multivariable adjusted OR was 1.05 (95% CI 1.02 to 1.09). In the stratified analyses, the association of vomiting in the first trimester was significant among underweight women (adjusted OR=1.08, 95% CI 1.04 to 1.17) and normal pre-pregnancy BMI women (adjusted OR=1.06, 95% CI 1.02 to 1.11), but not in overweight women (adjusted OR=1.01, 95% CI 0.90 to 1.14) and obese women (adjusted OR=0.93, 95% CI 0.73 to 1.19).

Conclusions

Our study indicates that vomiting in the first trimester was associated with PTB. Additionally, women with underweight and normal pre-pregnancy BMI who experienced vomiting are more likely to have a PTB.
Building a collaborative culture in cardiothoracic operating rooms: pre and postintervention study protocol for evaluation of the implementation of teamSTEPPS training and the impact on perceived psychological safety
Authors: Dahl Aaron Benjamin , Ben Abdallah Arbi , Maniar Hersh , Avidan Michael Simon , Bollini Mara L , Patterson George Alexander , Steinberg Aaron , Scaggs Katie , Dribin Brenda V , Ridley Clare H
Published: September 2017

Introduction

The importance of effective communication, a key component of teamwork, is well recognised in the healthcare setting. Establishing a culture that encourages and empowers team members to speak openly in the cardiothoracic (CT) operating room (OR) is necessary to improve patient safety in this high-risk environment.

Methods and analysis

This study will take place at Barnes-Jewish Hospital, an academic hospital in affiliation with Washington University School of Medicine located in the USA. All team members participating in cardiac and thoracic OR cases during this 17-month study period will be identified by the primary surgical staff attending on the OR schedule.

TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety) training course will be taught to all CT OR staff. Before TeamSTEPPS training, staff will respond to a 39-item questionnaire that includes constructs from the Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture, Edmondson’s ‘Measure of psychological safety’ questionnaire, and questionnaires on turnover intentions, job satisfaction and ‘burnout’. The questionnaires will be readministered at 6 and 12 months.

The primary outcomes to be assessed include the perceived psychological safety of CT OR team members, the overall effect of TeamSTEPPS on burnout and job satisfaction, and observed turnover rate among the OR nurses. As secondary outcomes, we will be assessing self-reported rates of medical error and near misses in the ORs with a questionnaire at the end of each case.

Ethics and dissemination

Ethics approval is not indicated as this project does not meet the federal definitions of research requiring the oversight of the Institutional Review Board (IRB). Patient health information (PHI) will not be generated during the implementation of this project. Results of the trial will be made accessible to the public when published in a peer-reviewed journal following the completion of the study.
Protocol for a randomised controlled implementation trial of point-of-care viral load testing and task shifting: the Simplifying HIV TREAtment and Monitoring (STREAM) study
Authors: Dorward Jienchi , Garrett Nigel , Quame-Amaglo Justice , Samsunder Natasha , Ngobese Hope , Ngomane Noluthando , Moodley Pravikrishnen , Mlisana Koleka , Schaafsma Torin , Donnell Deborah , Barnabas Ruanne , Naidoo Kogieleum , Abdool Karim Salim , Celum Connie , Drain Paul K
Published: September 2017

Introduction

Achieving the Joint United Nations Programme on HIV and AIDS 90-90-90 targets requires models of HIV care that expand antiretroviral therapy (ART) coverage without overburdening health systems. Point-of-care (POC) viral load (VL) testing has the potential to efficiently monitor ART treatment, while enrolled nurses may be able to provide safe and cost-effective chronic care for stable patients with HIV. This study aims to demonstrate whether POC VL testing combined with task shifting to enrolled nurses is non-inferior and cost-effective compared with laboratory-based VL monitoring and standard HIV care.

Methods and analysis

The STREAM (Simplifying HIV TREAtment and Monitoring) study is an open-label, non-inferiority, randomised controlled implementation trial. HIV-positive adults, clinically stable at 6 months after ART initiation, will be recruited in a large urban clinic in South Africa. Approximately 396 participants will be randomised 1:1 to receive POC HIV VL monitoring and potential task shifting to enrolled nurses, versus laboratory VL monitoring and standard South African HIV care. Initial clinic follow-up will be 2-monthly in both arms, with VL testing at enrolment, 6 months and 12 months. At 6 months (1 year after ART initiation), stable participants in both arms will qualify for a differentiated care model involving decentralised ART pickup at community-based pharmacies. The primary outcome is retention in care and virological suppression at 12 months from enrolment. Secondary outcomes include time to appropriate entry into the decentralised ART delivery programme, costs per virologically suppressed patient and cost-effectiveness of the intervention compared with standard care. Findings will inform the scale up of VL testing and differentiated care in HIV-endemic resource-limited settings.

Ethics and dissemination

Ethical approval has been granted by the University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC296/16) and University of Washington Institutional Review Board (STUDY00001466). Results will be presented at international conferences and published in academic peer-reviewed journals.

Trial registration

NCT03066128; Pre-results.