bluuebunny/crossref_metadata_2025 huggingface dataset:
The boundaries of mild chronic obstructive pulmonary disease (COPD): design of the searching clinical COPD onset (SOON) study
Authors: Labarca Gonzalo , Bustamante Andrea , Valdivia Gonzalo , Díaz Rodrigo , Huete Álvaro , Mac Nab Paul , Mendoza Laura , Leppe Jaime , Lisboa Carmen , Saldías Fernando , Díaz Orlando
Published: August 2017

Introduction

Clinical onset of chronic obstructive pulmonary disease (COPD) is the point at which the disease is first identifiable by physicians. It is a poorly defined stage which seems to include both mild spirometric and non-spirometric disease, and could be described as early grade COPD, for practical purposes. While dyspnoea; chronic bronchitis and CT imaging evidence of emphysema and airway disease may be present very early, the lone significance of dyspnoea, the most relevant symptom in COPD in identifying these individuals, has been scarcely assessed.

The Searching Clinical COPD Onset (SOON) Study was designed primarily to detect clinical, physiological and structural differences between dyspnoeic and non-dyspnoeic individuals with early grade COPD. It is hypothesised that presence of dyspnoea in early disease may identify a subtype of individuals with reduced exercise capacity, notwithstanding of their spirometry results. In addition, dyspnoeic individuals will share worse quality of life, lower physical activity, greater lung hyperinflation greater emphysema and airway thickness and reduced peripheral muscle mass than their non-dyspnoeic counterpart.

Methods and analysis

SOON is a monocentric study, with a cross sectional design aimed at obtaining representative samples of current or ex-smoker-adults aged ≥45 and ≤80 years. Two hundred and forty participants will be enrolled into four strata, according to normal spirometry or mild spirometric obstruction and presence or not of dyspnoea modified Medical Research Council score ≥1. The primary outcome will be the difference between dyspnoeic and non-dyspnoeic individuals on the 6-min walk test performance, regardless of their spirometry results. To account for the confounding effect of heart failure on dyspnoea, stress echocardiography will be also performed. Secondary outcomes will include clinical (quality of life, physical activity), physiological (exercise testing) and structural characteristics (emphysema, airway disease and peripheral muscle mass by CT imaging).

Ethics and dissemination

The Institutional Ethics Committee from Pontificia Universidad Católica de Chile has approved the study protocol and signed informed consent will be obtained from all participants. The findings of the trial will be disseminated through relevant peer-reviewed journals and international conference presentations.

Trial registration number

NCT03026439.
Radiographic features of importance in the National Institute for Occupational Safety and Health-administered Coal Workers’ Health Surveillance Program: characterising the use of the ‘other symbols’
Authors: Halldin Cara N , Hale Janet M , Blackley David J , Laney A Scott
Published: August 2017

Objective

The National Institute for Occupation Safety and Health-administered Coal Workers’ Health Surveillance Program (CWHSP) provides radiographic pneumoconiosis screening for US coal miners. Radiographs are classified by readers according to International Labour Office criteria. In addition to pneumoconiotic parenchymal and pleural lung abnormalities, readers document radiographic features of importance (other symbols). Other symbols are not meant to imply a diagnosis or interpretation but are relevant as they provide information beyond a pneumoconiosis classification for features related to dust exposure and other aetiologies. Our objective was to summarise other symbol data from 48 years of CWHSP participants.

Methods

Chest radiograph classifications obtained from CWHSP participants between July 1968 and July 2016 were analysed. Any ‘other symbol’ indication from any of the readings were counted. Frequencies were tabulated by individual reader and those identified by any reader.

Results

Of the 469 922 radiographs included in this study, nearly 15% had at least one reader identify a radiographic feature of importance. The most commonly identified other symbol was cancer (excluding mesothelioma) (6.83%), followed by emphysema (1.68%). Some features were rarely identified over the 48 years of data collection such as rheumatoid pneumoconiosis (n=46), pneumothorax (n=32), mesothelioma (n=12) and rounded atelectasis (n=4).

Conclusions

This is the largest study to date describing radiographic features of importance as part of routine chest radiographic surveillance. While these symbols are not diagnostic they can be used to describe features associated with dust exposure. One of the most commonly identified radiographic features in our population is emphysema which is associated with respirable dust exposure. These results can be compared with other dust exposed populations.
Health practitioners’ perceptions of adopting clinical prediction rules in the management of musculoskeletal pain: a qualitative study in Australia
Authors: Kelly Joan , Sterling Michele , Rebbeck Trudy , Bandong Aila Nica , Leaver Andrew , Mackey Martin , Ritchie Carrie
Published: August 2017

Objectives

To investigate health practitioners’ understanding and practice behaviours with regards to clinical prediction rules (CPRs) and explore their perceptions of adopting a new whiplash CPR.

Design

Qualitative study using six semistructured focus groups.

Setting

Primary and secondary care in New South Wales and Queensland, Australia.

Participants

Physiotherapists (n=19), chiropractors (n=6) and osteopaths (n=3) were purposively sampled to include health practitioners who provide routine treatment to people with whiplash-associated disorders.

Methods

Focus group discussions (n=6) were audio-recorded, transcribed verbatim and analysed using an inductive thematic approach.

Results

Health practitioners’ understanding and use of CPRs were mixed. Clinicians considered components relating to acceptability (‘whether I agree with it’) and implementation (‘how I'll use it’) when deciding on whether to adopt a new CPR. Acceptability was informed by four themes: knowledge and understanding, CPR type, congruence and weighted value. Consideration of matters that promote implementation occurred once a CPR was deemed to be acceptable. Three themes were identified as potentially enhancing whiplash CPR implementation: the presence of an external driver of adoption, flexibility in how the CPR could be administered and guidance regarding communication of CPR output to patients.

Conclusions

Education on CPR purpose and fit with practice is needed to enhance the perceived acceptability of CPRs. Strategies that facilitate practitioner motivation, enable administrative flexibility and assist clinicians in communicating the results of the whiplash CPR could promote adoption of the whiplash CPR.
Optic nerve sheath diameter sonography for the diagnosis of increased intracranial pressure: a systematic review and meta-analysis protocol
Authors: Koziarz Alex , Sne Niv , Kegel Fraser , Alhazzani Waleed , Nath Siddharth , Badhiwala Jetan H , Rice Timothy , Engels Paul , Samir Faidi , Healey Andrew , Kahnamoui Kamyar , Banfield Laura , Sharma Sunjay , Reddy Kesava , Hawryluk Gregory W J , Kirkpatrick Andrew W , Almenawer Saleh A
Published: August 2017

Introduction

Increased intracranial pressure (ICP) is a significant neurological issue that may lead to permanent neurological sequelae. When evaluating patients with traumatic brain injury, it is crucial to identify those with high ICP in order to expedite ICP lowering measures and maintain adequate cerebral perfusion. Several measures are used to recognise patients with increased ICP including CT scan, MRI, ICP monitor, and lumbar puncture (LP). However, these tests can be invasive, associated with radiation exposure, contraindicated, or not readily available. Ultrasonography measurement of the optic nerve sheath diameter (ONSD) is proposed as a non-invasive and quick measure to identify high ICP. The aim of this systematic review and meta-analysis will be to examine the accuracy of ONSD sonography for increased ICP diagnosis.

Methods and analyses

We will include published and unpublished randomised controlled trials, observational studies, and abstracts, with no publication type or language restrictions. Search strategies will be designed to peruse the MEDLINE, Embase, Web of Science, WHO Clinical Trials, ClinicalTrials.gov, CINAHL, and the Cochrane Library databases. We will also implement strategies to search grey literature. Two reviewers will independently complete data abstraction and conduct quality assessment. Included studies will be assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. We will construct the hierarchical summary receiver operating characteristic curve for included studies and pool sensitivity and specificity using the bivariate model. We also plan to conduct prespecified subgroup analyses to explore heterogeneity. The overall quality of evidence will be rated using Grading of Recommendations, Assessment, Development and Evaluations (GRADE).

Ethics and dissemination

Research ethics board approval is not required for this study as it draws from published data and raises no concerns related to patient privacy. This review will provide a comprehensive assessment of the evidence on ONSD sonography diagnostic accuracy and is directed to a wide audience. Results from the review will be disseminated extensively through conferences and submitted to a peer-reviewed journal for publication.

PROSPERO registration number

CRD42017055485.

Clinical trial number

Trial registration number isNCT00783809.
SSRI antidepressant use potentiates weight gain in the context of unhealthy lifestyles: results from a 4-year Australian follow-up study
Authors: Shi Zumin , Atlantis Evan , Taylor Anne W , Gill Tiffany K , Price Kay , Appleton Sarah , Wong Ma-Li , Licinio Julio
Published: August 2017

Objective

To examine the association between antidepressant use and weight gain, as well as the interaction with lifestyle factors.

Design

Longitudinal study.

Setting and participants

We used data from 2334 adults from two stages (4.4 years apart) of the North West Adelaide Health Study, including validated diet and lifestyle questionnaires, measured body weight and linked pharmaceutical prescription data.

Main outcome measures

Body weight change.

Results

188 (8.1%) participants had a mean annual number of 1–2 antidepressant prescriptions, and 212 (9.1%) had over two prescriptions. The mean annual weight gain was 0.12, 0.18 and 0.28 kg in non-users, low (1–2 prescriptions/year) and high (>2 prescriptions/year) antidepressant users, respectively. In multivariable regression models, antidepressant use was positively associated with weight gain: high antidepressant users gained an extra 0.22 (95% CI 0.00 to 0.44) kg per year. This association was mainly due to selective serotonin reuptake inhibitor (SSRI) use. High SSRI users gained 0.48 (95% CI 0.20 to 0.76) kg more than non-users. There was no association between tricyclic or other antidepressant use and weight gain. The association between SSRI use and weight gain was stronger among those with high intake of Western diet, greater sedentary activity, and who smoked.

Conclusions

SSRIs use was associated with weight gain in the presence of unhealthy behaviours including Western diet, sedentarism and smoking.
Protocol study for a randomised, controlled, double-blind, clinical trial involving virtual reality and anodal transcranial direct current stimulation for the improvement of upper limb motor function in children with Down syndrome
Authors: Lopes Jamile Benite Palma , Grecco Luanda André Collange , Moura Renata Calhes Franco de , Lazzari Roberta Delasta , Duarte Natalia de Almeida Carvalho , Miziara Isabela , Melo Gileno Edu Lameira de , Dumont Arislander Jonathan Lopes , Galli Manuela , Santos Oliveira Claudia
Published: August 2017

Introduction

Down syndrome results in neuromotor impairment that affects selective motor control, compromising the acquisition of motor skills and functional independence. The aim of the proposed study is to evaluate and compare the effects of multiple-monopolar anodal transcranial direct current stimulation and sham stimulation over the primary motor cortex during upper limb motor training involving virtual reality on motor control, muscle activity, cerebral activity and functional independence.

Methods and analysis

A randomised, controlled, double-blind, clinical trial is proposed. The calculation of the sample size will be defined based on the results of a pilot study involving the same methods. The participants will be randomly allocated to two groups. Evaluations will be conducted before and after the intervention as well as 1 month after the end of the intervention process. At each evaluation, three-dimensional analysis of upper limb movement muscle activity will be measured using electromyography, cerebral activity will be measured using an electroencephalogram system and intellectual capacity will be assessed using the Wechsler Intelligence Scale for Children. Virtual reality training will be performed three times a week (one 20 min session per day) for a total of 10 sessions. During the protocol, transcranial stimulation will be administered concomitantly to upper limb motor training. The results will be analysed statistically, with a p value≤0.05 considered indicative of statistical significance.

Ethical aspects and publicity

The present study received approval from the Institutional Review Board of Universidade Nove de Julho (Sao Paulo,Brazil) under process number 1.540.113 and is registered with the Brazilian Registry of Clinical Trials (N° RBR3PHPXB). The participating institutions have presented a declaration of participation. The volunteers will be permitted to drop out of the study at any time with no negative repercussions. The results will be published and will contribute evidence regarding the use of this type of intervention on children.
Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial
Authors: Kim Mikyung , Kim Jung-Eun , Lee Hye-Yoon , Kim Ae-Ran , Park Hyo-Ju , Kwon O-Jin , Kim Bo-Kyung , Cho Jung Hyo , Kim Joo-Hee
Published: August 2017

Introduction

Although insomnia is one of the most prevalent and disturbing symptoms among patients with cancer, it has not been properly managed. Electroacupuncture (EA) has received attention as a promising intervention for insomnia, and a few previous studies have reported that this intervention may be beneficial for treating insomnia in patients with cancer. The aim of this pilot study is to explore the feasibility and preliminary effectiveness of EA on the sleep disturbance of patients with cancer with insomnia using a subjective method, patient-reported questionnaires and an objective tool, actigraphy, to measure the quality of sleep.

Methods and analysis

This is a study protocol for a randomised, three-arm, multicentre, pilot clinical trial. A total of 45 patients with cancer who have continuous insomnia related to cancer treatment or cancer itself will be randomly allocated to an EA group, sham EA group or usual care group in equal proportions. The EA group will receive 10 sessions of EA treatment over 4 weeks. The sham EA group will receive sham EA at non-acupoints using non-penetrating Streitberger acupuncture needles with mock EA. The usual care group will not receive EA treatment. All participants will be provided a brochure on the management of sleep disorders regardless of their group assignment. The primary outcome measure is the mean change in the insomnia severity index from the baseline to week 5. Information related to sleep quality will also be obtained through the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Participants will complete the trial by visiting the research centre at week 9 for follow-up assessment.

Ethics and dissemination

This study protocol was approved by the institutional review boards of each research centre. Written informed consent will be obtained from all participants. The result of this study will be published in peer-reviewed journals or presented at academic conferences.

Trial registration number

KCT0002162; Pre-results.
‘It's trying to manage the work’: a qualitative evaluation of recruitment processes within a UK multicentre trial
Authors: Skea Zoë Christina , Treweek Shaun , Gillies Katie
Published: August 2017

Objectives

To explore trial site staff's perceptions regarding barriers and facilitators to local recruitment.

Design

Qualitative semi-structured interviews with a range of trial site staff from four trial sites in the UK. Interviews were analysed thematically to identify common themes across sites, barriers that could be addressed and facilitators that could be shared with other sites.

Participants

11 members of staff from four trial sites: clinical grant Co-applicant (n=1); Principal Investigators (n=3); Consultant Urologist (n=1); Research Nurses (n=5); Research Assistant (n=1).

Setting

Embedded within an ongoing randomised controlled trial (the TISU trial). TISU is a UK multicentre trial comparing therapeutic interventions for ureteric stones.

Results

Our study draws attention to the initial and ongoing burden of trial work that is involved throughout the duration of a clinical trial. In terms of building and sustaining a research culture, trial staff described the ongoing work of engagement that was required to ensure that clinical staff were both educated and motivated to help with the process of identifying and screening potential participants. Having adequate and sufficient organisational and staffing resources was highlighted as being a necessary prerequisite to successful recruitment both in terms of accessing potentially eligible patients and being able to maximise recruitment after patient identification. The nature of the research study design can also potentially generate challenging communicative work for recruiting staff which can prove particularly problematic.

Conclusions

Our paper adds to existing research highlighting the importance of the hidden and complex work that is involved in clinical trial recruitment. Those designing and supporting the operationalisation of clinical trials must recognise and support the mitigation of this ‘work’. While much of the work is likely to be contextually sensitive at the level of local sites and for individual trials, some aspects are ubiquitous issues for delivery of trials more generally.

Trial registration number

ISRCTN No 92289221; Pre-results.
Non-pharmacological self-management for people living with migraine or tension-type headache: a systematic review including analysis of intervention components
Authors: Probyn Katrin , Bowers Hannah , Mistry Dipesh , Caldwell Fiona , Underwood Martin , Patel Shilpa , Sandhu Harbinder Kaur , Matharu Manjit , Pincus Tamar
Published: August 2017

Objectives

To assess the effect of non-pharmacological self-management interventions against usual care, and to explore diﬀerent components and delivery methods within those interventions

Participants

People living with migraine and/or tension-type headache

Interventions

Non-pharmacological educational or psychological self-management interventions; excluding biofeedback and physical therapy.

We assessed the overall effectiveness against usual care on headache frequency, pain intensity, mood, headache-related disability, quality of life and medication consumption in meta-analysis.

We also provide preliminary evidence on the effectiveness of intervention components and delivery methods.

Results

We found a small overall effect for the superiority of self-management interventions over usual care, with a standardised mean diﬀerence (SMD) of −0.36 (−0.45 to −0.26) for pain intensity; −0.32 (−0.42 to −0.22) for headache-related disability, 0.32 (0.20 to 0.45) for quality of life and a moderate effect on mood (SMD=0.53 (−0.66 to −0.40)). We did not find an effect on headache frequency (SMD=−0.07 (−0.22 to 0.08)).

Assessment of components and characteristics suggests a larger effect on pain intensity in interventions that included explicit educational components (−0.51 (−0.68 to −0.34) vs −0.28 (−0.40 to −0.16)); mindfulness components (−0.50 (−0.82 to −0.18) vs 0.34 (−0.44 to −0.24)) and in interventions delivered in groups vs one-to-one delivery (0.56 (−0.72 to −0.40) vs −0.39 (−0.52 to −0.27)) and larger effects on mood in interventions including a cognitive–behavioural therapy (CBT) component with an SMD of −0.72 (−0.93 to −0.51) compared with those without CBT −0.41 (−0.58 to −0.24).

Conclusion

Overall we found that self-management interventions for migraine and tension-type headache are more effective than usual care in reducing pain intensity, mood and headache-related disability, but have no effect on headache frequency. Preliminary findings also suggest that including CBT, mindfulness and educational components in interventions, and delivery in groups may increase effectiveness.

Trial registration number

PROSPERO 2016:CRD42016041291
Patient preferences for venous thromboembolism prophylaxis after injury: a discrete choice experiment
Authors: Haac Bryce E , O'Hara Nathan N , Mullins C Daniel , Stein Deborah M , Manson Theodore T , Johal Herman , Castillo Renan , O'Toole Robert V , Slobogean Gerald P
Published: August 2017

Objective

Limited evidence for the optimal venous thromboembolism (VTE) prophylaxis regimen in orthopaedic trauma leads to variability in regimens. We sought to delineate patient preferences towards cost, complication profile, and administration route (oral tablet vs. subcutaneous injection).

Design

Discrete choice experiment (DCE).

Setting

Level 1 trauma center in Baltimore, USA.

Participants

232 adult trauma patients (mean age 47.9 years) with pelvic or acetabular fractures or operative extremity fractures.

Primary and secondary outcome measures

Relative preferences and trade-off estimates for a 1% reduction in complications were estimated using multinomial logit modelling. Interaction terms were added to the model to assess heterogeneity in preferences.

Results

Patients preferred oral tablets over subcutaneous injections (marginal utility, 0.16; 95% CI: 0.11 - 0.21,P<0.0001). Preferences changed in favor of subcutaneous injections with an absolute risk reduction of 6.98% in bleeding, 4.53% in wound complications requiring reoperation, 1.27% in VTE, and 0.07% in death from pulmonary embolism (PE). Patient characteristics (sex, race, type of injury, time since injury) affected patient preferences (P<0.01).

Conclusions

Patients preferred oral prophylaxis and were most concerned about risk of death from PE. Furthermore, the findings estimated the trade-offs acceptable to patients and heterogeneity in preferences for VTE prophylaxis.
Association between pregravid physical activity and family history of stroke and risk of stillbirth: population-based cohort study
Authors: Egeland Grace M , Tell Grethe S , Næss Øyvind , Igland Jannicke , Klungsøyr Kari
Published: August 2017

Objectives

To evaluate whether family history of disease and pregravid lifestyle and cardiovascular risk factors are associated with subsequent stillbirth delivery.

Design

Prepregnancy cohort study.

Setting

Cohort Norway regional health surveys (1994–2003) linked to Medical Birth Registry of Norway for deliveries through 2012.

Participants

13 497 singleton births (>22 weeks gestation) in 8478 women.

Main outcome measure

Risk of stillbirth evaluated by Poisson regression.

Results

Mean (SD) length of follow-up was 5.5 (3.5) years. In analyses adjusting for baseline age and length of follow-up, ≥3 hours of baseline past-year vigorous physical activity per week (resulting in shortness of breath/sweating) was associated with increased risk of stillbirth compared with <1 hour/week of vigorous activity (incidence rate ratio, IRR 2.46; 95% CI 1.23 to 4.90). In contrast, baseline past-year light physical activity of ≥3 hours per week associated with reduced risk of stillbirth compared with <3 hours of light physical activity per week (IRR 0.53; 95% CI 0.30 to 0.93). A family history of stroke associated with increased risk of stillbirth delivery (IRR 2.53; 95% CI 1.06 to 6.01). Because overweight/obese women may experience shortness of breath and sweating with less physical exertion than normal weight women, a sensitivity analysis was conducted limited to women with a normal BMI (>18.5 and <25 kg/m2). Vigorous activity of ≥3 hours per week (IRR of 4.50; 95% CI 1.72 to 11.79) and a family history of stroke (IRR of 3.81; 95% CI 1.31 to 11.07) were more strongly related to stillbirth risk among women with a normal BMI than that observed for all women combined. Established risk factors also associated with stillbirth risk.

Conclusions

The study identified physical activity and family history of stroke as potential new risk factors for stillbirth delivery.
Socioeconomic and geographical variation in general practitioner consultations for allergic rhinitis in England, 2003–2014: an observational study
Authors: Todkill Daniel , Loveridge Paul , Elliot Alex James , Morbey Roger , Lusignan Simon de , Edeghere Obaghe , Smith Gillian
Published: August 2017

Objective

Allergic rhinitis (AR) is a global health problem, potentially impacting individuals’ sleep, work and social life. We aimed to use a surveillance network of general practitioners (GPs) to describe the epidemiology of AR consultations in England.

Setting

A large GP surveillance network covering approximately 53% of the English population.

Methods

GP consultations for AR across England between 30 December 2002 and 31 December 2014 were analysed. Using more granular data available between 2 April 2012 and 31 December 2014 rates and rate ratios (RR) of AR were further analysed in different age groups, gender, rural-urban classification and index of multiple deprivation score quintile of location of GP.

Results

The mean weekly rate for AR consultations was 19.8 consultations per 100 000 GP registered patients (range 1.13–207), with a regular peak occurring during June (weeks 24–26), and a smaller peak during April. Between 1 April 2012 and 31 December 2014, the highest mean daily rates of consultations per 1 00 000 were: in age group 5–14 years (rate=8.02, RR 6.65, 95% CI 6.38 to 6.93); females (rate=4.57, RR 1.12 95% CI 1.12 to 1.13); persons registered at a GP in the most socioeconomically deprived quintile local authority (rate=5.69, RR 1.48, 95% CI 1.47 to 1.49) or in an urban area with major conurbation (rate=5.91, RR 1.78, 95% CI 1.69 to 1.87).

Conclusions

AR rates were higher in those aged 5–14 years, females and in urban and socioeconomically deprived areas. This needs to be viewed in the context of this study’s limitations but should be considered in health promotion and service planning.
Psychiatric disorders among people with cancer in low- and lower-middle-income countries: study protocol for a systematic review and meta-analysis
Authors: Walker Zoe J , Jones Michael P , Ravindran Arun V
Published: August 2017

Introduction

Cancer is a rapidly growing public health problem in low- and lower-middle-income countries (LLMICs). There is evidence from upper-income countries that comorbid mental illness is common and can adversely impact cancer outcomes. Little is known about this burden in LLMICs. This systematic review has two aims. The first is to review the prevalence and patterns of psychiatric comorbidity in adults with cancer in LLMICs. The second is to review psychiatric treatment outcomes in this population.

Methods and analysis

The review will be reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. A systematic search of electronic databases (MEDLINE, PsycInfo, Embase and CINAHL) will be conducted. Studies will be included if they report the prevalence of psychiatric comorbidity, or if they evaluate psychiatric treatment outcomes, in adults with cancer living in LLMICs. The search will be limited to studies published in peer-reviewed journals between March 2002 and March 2017. The reference lists of included studies will be hand searched. Critical appraisal will be performed using Quality Assessment Tools from the National Institute of Health. Pooled prevalence meta-analysis is planned.

Ethics and dissemination

Ethics approval is not required as no primary data will be collected. The results will be presented at conferences and published in a peer-reviewed journal.

Systematic review registration

PROSPERO CRD42017057103.
Developing core economic outcome sets for asthma studies: a protocol for a systematic review
Authors: Hounsome Natalia , Fitzsimmons Deborah , Phillips Ceri , Patel Anita
Published: August 2017

Introduction

Core outcome sets are standardised lists of outcomes, which should be measured and reported in all clinical studies of a specific condition. This study aims to develop core outcome sets for economic evaluations in asthma studies. Economic outcomes include items such as costs, resource use or quality-adjusted life years. The starting point in developing core outcome sets will be conducting a systematic literature review to establish a preliminary list of reporting items to be considered for inclusion in the core outcome set.

Methods and analysis

We will conduct literature searches of peer-reviewed studies published from January 1990 to January 2017. These will include any comparative or observational studies (including economic models) and systematic reviews reporting economic outcomes. All identified economic outcomes will be tabulated together with the major study characteristics, such as population, study design, the nature and intensity of the intervention, mode of data collection and instrument(s) used to derive an outcome. We will undertake a ‘realist synthesis review’ to analyse the identified economic outcomes. The outcomes will be summarised in the context of evaluation perspectives, types of economic evaluation and methodological approaches. Parallel to undertaking a systematic review, we will conduct semistructured interviews with stakeholders (including people with personal experience of asthma, health professionals, researchers and decision makers) in order to explore additional outcomes which have not been considered, or used, in published studies. The list of outcomes generated from the systematic review and interviews with stakeholders will form the basis of a Delphi survey to refine the identified outcomes into a core outcome set.

Ethics and dissemination

The review will not involve access to individual-level data. Findings from our systematic review will be communicated to a broad range of stakeholders including clinical guideline developers, research funders, trial registries, ethics committees and other regulators.
Differences in the pregnancy gestation period and mean birth weights in infants born to Indian, Pakistani, Bangladeshi and white British mothers in Luton, UK: a retrospective analysis of routinely collected data
Authors: Garcia Rebecca , Ali Nasreen , Guppy Andy , Griffiths Malcolm , Randhawa Gurch
Published: August 2017

Objective

To compare mean birth weights and gestational age at delivery of infants born to Indian, Pakistani, Bangladeshi and white British mothers in Luton, UK.

Design

Retrospective analysis using routinely recorded secondary data in Ciconia Maternity information System, between 2008 and 2013.

Setting

Luton, UK.

Participants

Mothers whose ethnicity was recorded as white British, Bangladeshi, Pakistani or Indian and living in Luton, aged over 16, who had a live singleton birth over 24 weeks of gestation were included in the analysis (n=14 871).

Outcome measures

Primary outcome measures were mean birth weight and gestational age at delivery.

Results

After controlling for maternal age, smoking, diabetes, gestation age, parity and maternal height and body mass index at booking, a significant difference in infants’ mean birth weight was found between white British and Indian, Pakistani and Bangladeshi infants, F(3, 12 287)=300.32, p<0.0001. The partial Eta-squared for maternal ethnicity was η2=0.067. The adjusted mean birth weight for white British infants was found to be 3377.89 g (95% CI 3365.34 to 3390.44); Indian infants, 3033.09 g (95% CI 3038.63 to 3103.55); Pakistani infants, 3129.49 g (95% CI 3114.5 to 3144.48); and Bangladeshi infants, 3064.21 g (95% CI 3041.36 to 3087.06). There was a significant association in preterm delivery found in primipara Indian mothers, compared with Indian mothers (Wald=8.192, df 1, p<0.005).

Conclusions

Results show important differences in adjusted mean birth weight between Indian, Pakistani, Bangladeshi and white British women. Moreover, an association was found between primipara Indian mothers and preterm delivery, when compared with Pakistani, Bangladeshi and white British women.
Associations between polypharmacy and treatment intensity for hypertension and diabetes: a cross-sectional study of nursing home patients in British Columbia, Canada
Authors: McCracken Rita , McCormack James , McGregor Margaret J , Wong Sabrina T , Garrison Scott
Published: August 2017

Objectives

Describe nursing home polypharmacy prevalence in the context of prescribing for diabetes and hypertension and determine possible associations between lower surrogate markers for treated hypertension and diabetes (overtreatment) and polypharmacy.

Design

Cross-sectional study.

Setting

6 nursing homes in British Columbia, Canada.

Participants

214 patients residing in one of the selected facilities during data collection period.

Primary and secondary outcome measures

Polypharmacy was defined as ≥9 regular medications. Overtreatment of diabetes was defined as being prescribed at least one hypoglycaemic medication and a glycosylated haemoglobin (HbA1c) ≤7.5%. Overtreatment of hypertension required being prescribed at least one hypertension medication and having a systolic blood pressure ≤128 mm Hg. Polypharmacy prescribing, independent of overtreatment, was calculated by subtracting condition-specific medications from total medications prescribed.

Results

Data gathering was completed for 214 patients, 104 (48%) of whom were prescribed ≥9 medications. All patients were very frail. Patients with polypharmacy were more likely to have a diagnosis of hypertension (p=0.04) or congestive heart failure (p=0.003) and less likely to have a diagnosis of dementia (p=0.03). Patients with overtreated hypertension were more likely to also experience polypharmacy (Relative Risk (RR))1.77 (1.07 to 2.96), p=0.027). Patients with overtreated diabetes were prescribed more non-diabetic medications than those with a higher HbA1c (11.0±3.7vs 7.2±3.1, p=0.01).

Conclusion

Overtreated diabetes and hypertension appear to be prevalent in nursing home patients, and the presence of polypharmacy is associated with more aggressive treatment of these risk factors. The present study was limited by its small sample size and cross-sectional design. Further study of interventions designed to reduce overtreatment of hypertension and diabetes is needed to fully understand the potential links between polypharmacy and potential of harms of condition-specific overtreatment.
Validation of asthma recording in the Clinical Practice Research Datalink (CPRD)
Authors: Nissen Francis , Morales Daniel R , Mullerova Hana , Smeeth Liam , Douglas Ian J , Quint Jennifer K
Published: August 2017

Objectives

The optimal method of identifying people with asthma from electronic health records in primary care is not known. The aim of this study is to determine the positive predictive value (PPV) of different algorithms using clinical codes and prescription data to identify people with asthma in the United Kingdom Clinical Practice Research Datalink (CPRD).

Methods

684 participants registered with a general practitioner (GP) practice contributing to CPRD between 1 December 2013 and 30 November 2015 were selected according to one of eight predefined potential asthma identification algorithms. A questionnaire was sent to the GPs to confirm asthma status and provide additional information to support an asthma diagnosis. Two study physicians independently reviewed and adjudicated the questionnaires and additional information to form a gold standard for asthma diagnosis. The PPV was calculated for each algorithm.

Results

684 questionnaires were sent, of which 494 (72%) were returned and 475 (69%) were complete and analysed. All five algorithms including a specific Read code indicating asthma or non-specific Read code accompanied by additional conditions performed well. The PPV for asthma diagnosis using only a specific asthma code was 86.4% (95% CI 77.4% to 95.4%). Extra information on asthma medication prescription (PPV 83.3%), evidence of reversibility testing (PPV 86.0%) or a combination of all three selection criteria (PPV 86.4%) did not result in a higher PPV. The algorithm using non-specific asthma codes, information on reversibility testing and respiratory medication use scored highest (PPV 90.7%, 95% CI (82.8% to 98.7%), but had a much lower identifiable population. Algorithms based on asthma symptom codes had low PPVs (43.1% to 57.8%)%).

Conclusions

People with asthma can be accurately identified from UK primary care records using specific Read codes. The inclusion of spirometry or asthma medications in the algorithm did not clearly improve accuracy.

Ethics and dissemination

The protocol for this research was approved by the Independent Scientific Advisory Committee (ISAC) for MHRA Database Research (protocol number15_257) and the approved protocol was made available to the journal and reviewers during peer review. Generic ethical approval for observational research using the CPRD with approval from ISAC has been granted by a Health Research Authority Research Ethics Committee (East Midlands—Derby, REC reference number 05/MRE04/87).

The results will be submitted for publication and will be disseminated through research conferences and peer-reviewed journals.
The provision of medical assistance in dying: protocol for a scoping review
Authors: Oczkowski Simon J W , Ball Ian , Saleh Carol , Kalles Gaelen , Chkaroubo Anatoli , Kekewich Mike , Miller Paul , Dees Marianne , Frolic Andrea
Published: August 2017

Introduction

Medical assistance in dying (MAID), a term encompassing both euthanasia and assisted suicide, was decriminalised in Canada in 2015. Although Bill C-14 legislated eligibility criteria under which patients could receive MAID, it did not provide guidance regarding the technical aspects of providing an assisted death. Therefore, we propose a scoping review to map the characteristics of the existing medical literature describing the medications, settings, participants and outcomes of MAID, in order to identify knowledge gaps and areas for future research.

Methods and analysis

We will search electronic databases (MEDLINE, EMBASE, CINAHL, CENTRAL, PsycINFO), clinical trial registries, conference abstracts, and professional guidelines and recommendations from jurisdictions where MAID is legal, up to June 2017. Eligible report types will include technical summaries, institutional policies, practice surveys, practice guidelines and clinical studies. We will include all descriptions of MAID provision (either euthanasia or assisted suicide) in adults who have provided informed consent for MAID, for any reason, including reports where patients have provided consent to MAID in advance of the development of incapacity (eg, dementia). We will exclude reports in which patients receive involuntary euthanasia (eg, capital punishment). Two independent investigators will screen and select retrieved reports using pilot-tested screening and eligibility forms, and collect data using standardised data collection forms. We will summarise extracted data in tabular format with accompanying descriptive statistics and use narrative format to describe their clinical relevance, identify knowledge gaps and suggest topics for future research.

Ethics and dissemination

This scoping review will map the range and scope of the existing literature on the provision of MAID in jurisdictions where the practice has been decriminalised. The review will be disseminated through conference presentations and publication in a peer-reviewed journal. These results will be useful to clinicians, policy makers and researchers involved with MAID.
A simple algorithmic approach using histology and immunohistochemistry for the current classification of adult diffuse glioma in a resource-limited set-up
Authors: Rajeswarie R T , Rao Shilpa , Nandeesh Bevinahalli N , Yasha T Chickabasaviah , Santosh Vani
Published: August 2017

Aims

The WHO 2016 classification of diffuse gliomas combines histological and molecular parameters for diagnosis. However, in view of cost constraints for molecular testing, an economical working formula is essential to reach a meaningful diagnosis in a resource-limited setting. The aim of this study was to establish a practical algorithmic approach using histology and immunohistochemistry (IHC) in the classification of diffuse gliomas in such a set-up.

Methods

Diffuse gliomas of WHO grade II and III diagnosed in our institute in the year 2016 were analysed for histological and IHC features, using the markers isocitrate dehydrogenase 1 (IDH1R132H) and α thalassemia/mental retardation syndrome X-linked gene (ATRX). Fluorescence in situ hybridisation (FISH) for 1p/19q co-deletion was performed when requested.

Results

449 diffuse gliomas (grades II/III) were included in the study. Integrating histology and IHC features, as per the WHO 2016 guidelines, we derived the following groups: Astrocytoma, IDH-mutant (A,IDH-mt, 37.2%); astrocytoma, not otherwise specified (A,NOS, 12.7%); oligoastrocytoma, NOS (OA,NOS, 4.5%); and oligodendroglioma, NOS (ODG,NOS, 45.6%). FISH was performed in a subset of ODG,NOS, OA,NOS and A,NOS gliomas. This revealed 1p/19q co-deletion in all cases of ODG,NOS, 15.8% of OA,NOS and 37.5% of A,NOS. Sequencing for rare IDH 1/2 mutations was not carried out in this study.

Conclusion

In a resource-limited set-up, histology with IHC (IDH1(R132H) and ATRX) form the baseline to reasonably derive four histomolecular subgroups of diffuse glioma. Of these, we recommend, OA,NOS and IDH1(R132H)-non-mt ODG,NOS to be our priority for performing 1p/19q co-deletion studies in comparison to IDH-mt ODG,NOS, and it would not be mandatory for astrocytoma. Sequencing for rare IDH mutations is advised for A,NOS and OA,NOS groups, but not for the IDH1(R132H)-non-mutant diffuse gliomas with 1p/19q co-deletion.
Trends in cigarette consumption and time to first cigarette on awakening from 2002 to 2015 in the USA: new insights into the ongoing tobacco epidemic
Authors: Goodwin Renee D , Wall Melanie M , Gbedemah Misato , Hu Mei-Chen , Weinberger Andrea H , Galea Sandro , Zvolensky Michael J , Hangley Elizabeth , Hasin Deborah S
Published: August 2017

Objective

The current study estimates trends in the number of cigarettes smoked per day (CPD) and percentage of smokers having their first CPD within 30 min of waking (time to first cigarette (TTFC)<30 min) among smokers from 2002 to 2015 in the USA overall, and adjusting for demographics. Trends in TTFC<30 min were also estimated by varying levels of cigarette consumption.

Methods

Data were drawn from the National Household Survey on Drug Use, an annual nationally representative cross-sectional study of the US population aged 12 and older (n=54 079–58 397 per year). Linear time trend analyses of CPD and TTFC<30 min were conducted adjusting for age, gender and income; linear time trend analyses of TTFC among those at varying levels of CPD were then performed.

Results

Estimates suggest that CPD declined overall from 2002 to 2015, and that the prevalence of TTFC<30 min declined overall among smokers (p<0.0001). The proportion of smokers consuming fewer (ie, 1–5, 6–15) CPD has increased while the number consuming 16+ CPD has decreased overall. Among those smoking 1–5 (p=0.0006) and 6–15 (p<0.0001) CPD, TTFC<30 min has increased significantly, but TTFC<30 min has remained unchanged among those smoking 16 or more CPD (p=0.5838).

Conclusions

Findings suggest that smokers today are consuming fewer CPD, yet are increasingly likely to have their first cigarette earlier on awakening than they were a decade ago. Intervention and outreach efforts aimed at moving the prevalence lower may benefit from evaluating and addressing nicotine dependence even among lighter smokers.
Potential of phytoceuticals to affect antibiotic residue detection tests in cow milk in a randomised trial
Authors: Mullen Keena AE , Beasley Erin , Rizzo Julio Q , Washburn Steven P , Baynes Ronald E , Mason Sharon E , Anderson Kevin L
Published: August 2017

Mastitis is a costly disease for dairy farmers. Some dairy farmers use herbal products, or phytoceuticals, to treat mastitis. Phytoceuticals have not been approved for this use by the United States Food and Drug Administration, and have not been tested to determine how they impact antibiotic residue detection testing. The current study tested the potential for phytoceuticals to cause positive results on two milk antibiotic residue screening tests, the Delvotest P and Charm SL Beta‐lactam test, or to interfere with the detection of antibiotics by these tests.

The three phytoceuticals tested were labelled for intramammary, topical or intravulvar administration. Testing was performed in vitro using the products diluted in milk obtained from healthy organic dairy cows. Phytoceuticals were tested at concentrations ranging from 1.5 per cent to 100 per cent. Concentration levels were replicated at least twice on each milk antibiotic residue screening test. The Delvotest P is based on detection of bacterial inhibitors and no positive results were obtained for any product at concentrations less than 50 per cent. The Charm SL Beta‐lactam test uses a receptor for the detection of beta‐lactam antibiotics and no concentration of phytoceuticals caused an interference with these tests.

Based on dilution of the products in bovine milk at physiologically achievable levels, phytoceutical products tested at levels expected after treatment do not cause positive test results for the Delvotest P nor do they interfere with the Charm SL Beta‐lactam test in detection of various antibiotics.