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Pragmatic cluster randomised double-blind pilot and feasibility trial of an active behavioural physiotherapy intervention for acute non-specific neck pain: a mixed-methods protocol

Por: Wiangkham · T. · Uthaikhup · S. · Rushton · A. B.

Non-specific neck pain causes pain and disability and contributes substantial socioeconomic burden internationally. Up to 50% of adults experience neck pain annually, leading to reduced the quality of life. An active behavioural physiotherapy intervention (ABPI) may be feasible to manage patients with acute non-specific neck pain to prevent transition to chronicity. A recent pilot and feasibility trial investigating an acute whiplash-associated disorder population found potential value of the ABPI with 95% of participants fully recovered (Neck Disability Index: NDI ≤4, compared with 17% in the standard physiotherapy arm); supporting a definitive trial. Qualitative findings from the physiotherapists supported the potential of the ABPI in a non-specific neck pain population.

Methods and analysis

Two phases: (1) Pragmatic cluster randomised double-blind, parallel 2-arm (ABPI vs standard physiotherapy intervention) pilot and feasibility trial to evaluate the procedures and feasibility of the ABPI for the management of acute non-specific neck pain. Six physiotherapy departments from six public hospitals in Thailand will be recruited and cluster randomised by a computer-generated randomisation sequence with block sampling. Sixty participants (30 each arm, 10 per hospital) will be assessed at baseline and 3 months following baseline for NDI, Numerical Rating Scale for pain intensity, cervical range of motion, fear-avoidance beliefs questionnaire and EuroQol-5 dimensions 5 levels outcomes, and (2) Embedded qualitative study using semistructured interviews to explore acceptability of the ABPI to participants (n=12) and physiotherapists (n=3). Descriptive analysis of the quantitative data and interpretative phenomenological analysis to code and analyse qualitative data (deductive and inductive) will inform feasibility for a future definitive trial.

Ethics and dissemination

This trial is approved by the Naresuan University Institutional Review Board (NUIRB_0380/61).

Trial registration number and status

TCTR20180607001; Recruiting commenced 1 February 2019.

Prospective longitudinal study of tobacco company adaptation to standardised packaging in the UK: identifying circumventions and closing loopholes

Por: Evans-Reeves · K. A. · Hiscock · R. · Lauber · K. · Gilmore · A. B.

UK standardised packaging legislation was introduced alongside pack size and product descriptor restrictions of the European Union Tobacco Products Directive to end tobacco marketing and misinformation via the pack. This paper aims to assess compliance with the restrictions and identify attempts to continue to market tobacco products and perpetuate misperceptions of harm post legislation.

Design, setting and intervention

A prospective study of the introduction of standardised packaging of tobacco products to the UK.

Participants and outcomes

We analysed commercial sales data to assess whether the legally required changes in pack branding, size and name were implemented. To explore any adaptations to products and packaging we analysed sales data, monthly pack purchases of factory-made (FM) cigarettes and roll-your-own (RYO) tobacco, tobacco advertisements from retail trade magazines and articles on tobacco from commercial literature (retail trade, market analyst and tobacco company publications).


One month after full implementation of the UK and European Union policies, 97% FM and 98% RYO was sold in compliant packaging. Nevertheless, tobacco companies made adaptations to tobacco products which enabled continued brand differentiation after the legislation came into force. For example, flavour names previously associated with low tar were systematically changed to colour names arguably facilitating continued misperceptions about the relative harms of products. Tobacco companies used the 1-year sell-through to their advantage by communicating brand name changes and providing financial incentives for retailers to buy large volumes of branded packs. In addition, tobacco companies continued to market their products to retailers and customers by innovating exemptions to the legislation, namely, filters, packaging edges, seals, multipack outers, RYO accessories, cigars and pipe tobacco.


Tobacco companies adapted to packaging restrictions by innovating their tobacco products and marketing activities. These findings should enable policy makers globally to close loopholes and increase the potential efficacy of standardised packaging policies.

Adaptation and Implementation of a Family Caregiver Skills Training Program: From Single Site RCT to Multisite Pragmatic Intervention



We describe an approach to rapidly adapt and implement an education and skills improvement intervention to address the needs of family caregivers of functionally impaired veterans—Helping Invested Families Improve Veterans’ Experience Study (HI‐FIVES).


Prior to implementation in eight sites, a multidisciplinary study team made systematic adaptations to the curriculum content and delivery process using input from the original randomized controlled trial (RCT); a stakeholder advisory board comprised of national experts in caregiver education, nursing, and implementation; and a veteran/caregiver engagement panel. To address site‐specific implementation barriers in diverse settings, we applied the Replicating Effective Programs implementation framework.


Adaptations to HI‐FIVES content and delivery included identifying core/noncore curriculum components, reducing instruction time, and simplifying caregiver recruitment for clinical settings. To enhance curriculum flexibility and potential uptake, site personnel were able to choose which staff would deliver the intervention and whether to offer class sessions in person or remotely. Curriculum materials were standardized and packaged to reduce the time required for implementation and to promote fidelity to the intervention.


The emphasis on flexible intervention delivery and standardized materials has been identified as strengths of the adaptation process. Two key challenges have been identifying feasible impact measures and reaching eligible caregivers for intervention recruitment.

Clinical Relevance

This systematic implementation process can be used to rapidly adapt an intervention to diverse clinical sites and contexts. Nursing professionals play a significant role in educating and supporting caregivers and care recipients and can take a leading role to implement interventions that address skills and unmet needs for caregivers.

The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study

Por: Corcoran · T. B. · Myles · P. S. · Forbes · A. B. · O'Loughlin · E. · Leslie · K. · Story · D. · Short · T. G. · Chan · M. T. · Coutts · P. · Sidhu · J. · Cheng · A. C. · Bach · L. A. · Ho · K. M. · on behalf of the Australian and New Zealand College of Anaesthetists Clinical Tri

The intraoperative administration of dexamethasone for prophylaxis against postoperative nausea and vomiting is a common and recommended practice. The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications.


This is a pragmatic, multicentre, randomised, controlled, non-inferiority trial. A total of 8880 patients undergoing elective major surgery will be enrolled. Participants will be randomly allocated to receive either dexamethasone 8 mg or placebo intravenously following the induction of anaesthesia in a 1:1 ratio, stratified by centre and diabetes status. Patient enrolment into the trial is ongoing. The primary outcome is surgical site infection at 30 days following surgery, defined according to the Centre for Disease Control criteria.


The PADDI trial has been approved by the ethics committees of over 45 participating sites in Australia, New Zealand, Hong Kong, South Africa and the Netherlands. The trial has been endorsed by the Australia and New Zealand College of Anaesthetists Clinical Trials Network and the Australian Society for Infectious Diseases Clinical Research Network. Participant recruitment began in March 2016 and is expected to be complete in mid-2019. Publication of the results of the PADDI trial is anticipated to occur in early 2020.

Trial registration number


Out-of-sequence DTP and measles vaccinations and child mortality in Guinea-Bissau: a reanalysis

Por: Thysen · S. M. · Rodrigues · A. · Aaby · P. · Fisker · A. B.

To assess whether the sequence of diphtheria-tetanus-pertussis vaccine (DTP) and measles vaccine (MV) was associated with child survival in a dataset previously used to assess non-specific effects of vaccines with no consideration of vaccination sequence.


Prospective cohort study analysed using the landmark approach.


Bandim Health Project’s Health and Demographic Surveillance System covering 100 village clusters in rural Guinea-Bissau. The recommended vaccination schedule was BCG and oral polio vaccine (OPV) at birth, DTP and OPV at 6, 10 and 14 weeks, MV at 9 months and booster DTP and OPV at 18 months of age.


Children aged 9–17 months (main analysis) and 18–35 months (secondary analysis: age of booster DTP) with vaccination status assessed between April 1991 and April 1996.


Survival during the 6 months after assessing vaccination status was compared by vaccination sequence in Cox-proportional hazards models with age as underlying time. Analyses were stratified by sex and village cluster.

Main outcome measure

Mortality rate ratio (MRR) for out-of-sequence vaccinations compared with in-sequence vaccinations.


Among children aged 9–17 months, 60% of observations (3574/5937) were from children who had received both MV and DTP. Among these, 1590 observations were classified as in-sequence vaccinations (last DTP before MV), and 1984 observations were out-of-sequence vaccinations (1491: MV with DTP and 493: MV before DTP). Out-of-sequence vaccinations were associated with higher mortality than in-sequence vaccinations (MRR 2.10, 95% CI 1.07 to 4.11); the MRR was 2.30 (95% CI 1.15 to 4.58) for MV with DTP and 1.45 (95% CI 0.50 to 4.22) for DTP after MV. Associations were similar for boys and girls (p=0.77). Between 18 and 35 months the mortality rate increased among children vaccinated in-sequence and the differential effect of out-of-sequence vaccinations disappeared.


Out-of-sequence vaccinations may increase child mortality. Hence, sequence of vaccinations should be considered when planning vaccination programmes or introducing new vaccines into the current vaccination schedule.

Rationale and design of a statewide telestroke registry: Lone Star Stroke Consortium Telestroke Registry (LeSteR)

Por: Astudillo · C. · Ankrom · C. · Trevino · A. · Malazarte · R. M. · Bambhroliya · A. B. · Savitz · S. · Topel · C. H. · Milling · T. J. · Wu · T.-C.

The Lone Star Stroke Consortium Telestroke Registry (LeSteR) currently consisting of 3 academic hub centres and 27 partner spokes is a statewide initiative organised by leading academic health centres in the State of Texas to understand practice patterns of acute stroke management via telestroke (TS) in Texas, a state with one of the largest rural populations in the USA.

Methods and analysis

All patients who had presumed stroke for whom a TS consultation has been obtained in the network are entered into a web-based, Health Insurance Portability and Accountability Act-compliant database from September 2013 to present. Spokes were enrolled into LeSteR in a staggered approach in two data collection phases: a retrospective phase and a prospective phase. Basic clinical, demographic data and relevant time metrics are collected in the retrospective phase. Starting 1 September 2015, additional outcome data including 90-day modified Rankin score, readmission and 90-day disposition are obtained by a standard phone interview. From the registry initiation to 31 December 2017, there are 8089 patients who had suspected stroke in the registry. Over 60% of patients enrolled after 1 September 2015 have reported outcome data. Enrolment is still active for this registry.

Ethics and dissemination

LeSteR is a statewide TS registry organised by academic health centres that will provide significant insight regarding the impact of TS in the State of Texas. Findings from LeSteR will provide data that can be analysed to improve the allocation of healthcare resources using TS to treat stroke in a state with one of the largest rural populations.

Characterisation of the fibroinflammatory process involved in progression from acute to chronic pancreatitis: study protocol for a multicentre, prospective cohort study

Por: Novovic · S. · Borch · A. · Werge · M. · Karran · D. · Gluud · L. · Schmidt · P. N. · Hansen · E. F. · Nojgaard · C. · Jensen · A. B. · Jensen · F. K. · Frokjaer · J. B. · Hansen · M. B. · Jorgensen · L. N. · Drewes · A. M. · Olesen · S. S.

Chronic pancreatitis (CP) is thought to present the end stage of a continuous disease process evolving from acute pancreatitis (AP), over recurrent AP, to early and end-stage CP. Due to the irreversible nature of CP, early detection and prevention is key. Prospective assessment based on advanced imaging modalities as well as biochemical markers of inflammation, fibrosis and oxidative stress may provide a better understanding of the underlying pathological processes and help identify novel biomarkers of disease with the ultimate goal of early diagnosis, intervention and prevention of disease progression. This paper describes the protocol of a prospective multicentre cohort study investigating the fibroinflammatory process involved in progression from acute to CP using state-of-the-art diagnostic imaging modalities and circulating biomarkers of inflammation, fibrosis and oxidative stress.

Methods and analysis

Adult control subjects and patients at different stages of CP according to the M-ANNHEIM system will be recruited from outpatient clinics at the participating sites and form three cohorts: controls (n=40), suspected CP (n=60) and definitive CP (n=60). Included patients will be followed prospectively for 15 years with advanced MRI and contrast-enhanced endoscopic ultrasound with elastography, assessment of endocrine and exocrine pancreatic function, biochemical and nutritional assessment, and evaluation of pain processing using quantitative sensory testing. Blood samples for a biobank will be obtained. The purpose of the biobank is to allow analyses of potential circulating biomarkers of disease progression, including markers of inflammation, fibrosis and oxidative stress.

Ethics and dissemination

Permissions from the Regional Science Ethics committee and the Regional Data Protection Agency have been obtained. We will submit the results of the study for publication in peer-reviewed journals regardless of whether the results are positive, negative or inconclusive.

Efficacy and safety of the combination of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease in lung transplant recipients (CYTOCOR STUDY): an open-label, randomised, non-inferiority clinical trial

Por: Paez-Vega · A. · Cantisan · S. · Vaquero · J. M. · Vidal · E. · Luque-Pineda · A. · Lobo-Acosta · M. A. · Perez · A. B. · Alonso-Moralejo · R. · Iturbe · D. · Monforte · V. · Otero-Gonzalez · I. · Pastor · A. · Ussetti · P. · Torre-Cisneros · J.

Prolonged use of antivirals to prevent the development of cytomegalovirus (CMV) disease in lung transplant patients has been shown to have significant side effects, for which alternatives are being sought to reduce their use. The monitoring of cell immunity against CMV could be an alternative as it has shown to be useful in identifying transplant patients at low risk of infection, who could benefit from shorter prophylaxis. The aim of the CYTOCOR study is to demonstrate that the combination of a reduced prophylaxis strategy with subsequent CMV-specific immunological monitoring would allow CMV infection to be controlled in lung transplant patients as effectively as the usual strategy (prophylaxis followed by pre-emptive therapy), while reducing the side effects of antivirals due to the shorter duration of prophylaxis.

Methods and analysis

Phase III randomised, open, multicentre, parallel, non-inferiority clinical trial to study the efficacy and safety of the combination of a prophylaxis strategy up to month +3 post-transplant followed by immuno-guided prophylaxis using the QuantiFERON-CMV technique up to month +12 post-transplant to prevent CMV disease in CMV-seropositive lung transplant recipients. This strategy will be compared with a combination of a usual prophylaxis strategy up to month +6 post-transplant followed by pre-emptive therapy up to month +12. To study the incidence of CMV disease, patients will be followed up to 18 months post-transplantation. A total of 150 patients are expected to be recruited for the study.

Ethics and public dissemination

The clinical trial has been approved by the Research Ethics Committees and authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS).

If the hypothesis of this clinical trial is verified, the dissemination of the results could change clinical practice by increasing knowledge about the safety and efficacy of discontinuing valganciclovir prophylaxis in lung transplant recipients.

Trial registration number


Patient journey following lumbar discectomy surgery: protocol for a single-centre qualitative analysis of the patient rehabilitation experience (DiscJourn)

Por: White · L. · Heneghan · N. R. · Furtado · N. · Masson · A. · Rushton · A. B.

Lumbar discectomy is a widely used surgical procedure internationally with the majority of patients experiencing significant benefit. However, approximately 20% of patients report suboptimal functional recovery and quality of life. The impact and meaning of the surgical experience from the patients’ perspective are not fully understood. Furthermore, there is limited evidence guiding postoperative management with significant clinical practice variation and it is unclear if current postoperative support is valued, beneficial or meets patients’ needs and expectations. This study aims to address the evidence gap by moving beyond current knowledge to gain insight into the lived experiences relating to patients’ lumbar discectomy surgery journey. Results will inform more meaningful and specific care, thus, enhance rehabilitation and outcomes.

Methods and analysis

A qualitative investigation using interpretative phenomenology analysis (IPA) will provide a flexible inductive research approach. A purposive sample (n=20) of patients undergoing primary discectomy will be recruited from one UK NHS secondary care centre. Semi-structured interviews will be conducted postsurgery discharge. A topic guide, developed from the literature and our previous work with input from two patient co-investigators, will guide interviews with the flexibility to explore interesting or patient-specific points raised. Providing longitudinal data, patients will keep weekly diaries capturing experiences and change over time throughout 12 months following surgery. A second interview will be completed 1 year postsurgery with its topic guide informed by initial findings. This combination of patient interviews and diaries will capture patients’ attitudes and beliefs regarding surgery and recovery, facilitators and barriers to progress, experiences regarding return to activities/function and interactions with healthcare professionals. The rich density of data will be thematically analysed in accordance with IPA, supported by NVivo software.

Ethics and dissemination

Ethical approval has been granted by the London-Bloomsbury Research Ethics Committee (18/LO/0459; IRAS 241345). Conclusions will be disseminated through conferences and peer-reviewed journals.

Cognition may link cortical IGFBP5 levels with motor function in older adults

by Aron S. Buchman, Lei Yu, Vladislav A. Petyuk, Chris Gaiteri, Shinya Tasaki, Katherine D. Blizinsky, Julie A. Schneider, Philip L. De Jager, David A. Bennett

Alzheimer’s disease and related disorders (ADRD) may manifest cognitive and non-cognitive phenotypes including motor impairment, suggesting a shared underlying biology. We tested the hypothesis that five cortical proteins identified from a gene network that drives AD and cognitive phenotypes are also related to motor function in the same individuals. We examined 1208 brains of older adults with motor and cognitive assessments prior to death. Cortical proteins were quantified with SRM proteomics and we collected indices of AD and other related pathologies. A higher level of IGFBP5 was associated with poorer motor function proximate to death but AK4, HSPB2, ITPK1 and PLXNB1 were unrelated to motor function. The association of IGFBP5 with motor function was unrelated to the presence of indices of brain pathologies. In contrast, the addition of a term for cognition attenuated the association of IGFBP5 with motor function by about 90% and they were no longer related. These data lend support for the idea that unidentified cortical proteins like IGFBP5, which may not manifest a known pathologic footprint, may contribute to motor and cognitive function in older adults.

Does childbirth experience affect infant behaviour? Exploring the perceptions of maternity care providers

In the UK, the number of women experiencing ‘normal’ birth is debated, with quoted figures ranging from 19.9 to 40% (Royal College of Midwives, 2016). Whilst sometimes lifesaving, procedures such as induction and caesarean sections are occurring at a higher rate than ten years ago (NHS Maternity Statistics Wales 2015-16; NHS England 2016-17; NMPA, 2017). These interventions entail risk, and normal birth is associated with better physical health outcomes for the mother–infant dyad (Lydon-Rochelle et al., 2000; Hansen et al., 2008; McIntyre et al., 2013; WHO, 2018).

Exploring maternal and health professional beliefs about the factors that affect whether women in Saudi Arabia attend antenatal care clinic appointments

Globally, over 30,000 women die each year during pregnancy and childbirth (Alkema et al., 2016) predominantly as a result of pregnancy and birth related complications (Alkema et al., 2016). Reducing these figures is a global priority, and increasing provision of antenatal care is a critical part of this (WHO, 2016). Antenatal care (ANC) can decrease the rate of both maternal and infant morbidity and mortality by allowing early identification and treatment of complications (WHO, 2014). It allows practitioners to support and monitor maternal and infant health through medical screening, checking for signs of abnormality and providing nutrition and health education (Roberts, 2015).

A comparison of nurse shift workers’ and non‐shift workers’ psychological functioning and resilience



To investigate the impact of shift work on the psychological functioning and resilience of nurses by comparing nurses who work shifts and nurses who work regular hours.


A comparative descriptive design using an online self‐report questionnaire.


Data were collected from employed Registered and Enrolled Nurses (N = 1,369) who were members of the Queensland Nurses and Midwives Union (QNMU) in 2013. The survey included standardized measures of resilience, depression, anxiety, compassion satisfaction, compassion fatigue, and intention to leave the profession.


Generalized Linear Mixed Model analysis revealed shift workers had significantly lower levels of compassion satisfaction. However, there were no significant differences between the groups on resilience, depression, anxiety, stress, compassion fatigue or intention to leave nursing.


The findings suggest that shift work is not associated with worse psychological functioning or lower resilience in nurses. However, this study requires replication using a longitudinal design to confirm these findings.

Cohort profile : Bandim Health Projects (BHP) rural Health and Demographic Surveillance System (HDSS)--a nationally representative HDSS in Guinea-Bissau

Por: Thysen · S. M. · Fernandes · M. · Benn · C. S. · Aaby · P. · Fisker · A. B.

Bandim Health Project (BHP) monitors health and survival of women and children in a nationally representative rural Health and Demographic Surveillance System (HDSS) in Guinea-Bissau. The HDSS was set up in 1989–1990 to collect data on health interventions and child mortality.


The HDSS covers 182 randomly selected clusters across the whole country. The cohort is open, and women and children enter the cohort, when they move into the selected clusters, and leave the cohort, when they move out or die, or when children reach 5 years of age. Data are collected through biannual or more frequent household visits. At all village visits, information on pregnancies, vital status, vaccination status, arm circumference, use of bed nets and other basic information is collected for women and children. Today, more than 25 000 women and 23 000 children below the age of 5 years are under surveillance.

Findings to date

Research from the BHP has given rise to the hypothesis that vaccines, in addition to their targeted effects, have important non-specific effects altering the susceptibility to other infections. Initially, it was observed that mortality among children vaccinated with the live BCG or measles vaccines was much lower than the mortality among unvaccinated children, a difference, which could not be explained by prevention of tuberculosis and measles infections. In contrast, mortality tended to be higher for children who had received the non-live Diphtheria-Tetanus-Pertussis vaccine compared with children who had not received this vaccine. Since the effect differed for the different vaccines, no bias explained the contrasting findings.

Future plans

New health interventions are introduced with little assessment of real-life effects. Through the HDSS, we can describe both the implementation of interventions (eg, the vaccination programme) and their effects. Furthermore, the intensive follow-up allows the implementation of randomised trials testing potential better vaccination programmes.

Efficacy and safety of cannabidiol followed by an open label add-on of tetrahydrocannabinol for the treatment of chronic pain in patients with rheumatoid arthritis or ankylosing spondylitis: protocol for a multicentre, randomised, placebo-controlled study

Por: Hendricks · O. · Andersen · T. E. · Christiansen · A. A. · Primdahl · J. · Hauge · E. M. · Ellingsen · T. · Horsted · T. I. · Bachmann · A. G. · Loft · A. G. · Bojesen · A. B. · Ostergaard · M. · Lund Hetland · M. · Krogh · N. S. · Roessler · K. K. · Petersen · K. H.

Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are chronic, systemic, inflammatory diseases, primarily in the musculoskeletal system. Pain and fatigue are key symptoms of RA and AS. Treatment presents a clinical challenge for several reasons, including the progressive nature of the diseases and the involvement of multiple pain mechanisms. Moreover, side effects of pain treatment pose an implicit risk. Currently, no well-controlled studies have investigated how medical cannabis affects pain and cognitive functions in RA and AS. The present study aims to evaluate the efficacy and safety of medical cannabis in the treatment of persistent pain in patients with RA and AS with low disease activity.

Methods and analysis

A double-blinded, randomised, placebo-controlled study of cannabidiol (CBD), followed by an open label add-on of tetrahydrocannabinol (THC) with collection of clinical data and biological materials in RA and AS patients treated in routine care. The oral treatment with CBD in the experimental group is compared with placebo in a control group for 12 weeks, followed by an observational 12-week period with an open label add-on of THC in the primary CBD non-responders. Disease characteristics, psychological parameters, demographics, comorbidities, lifestyle factors, blood samples and serious adverse events are collected at baseline, after 12 and 24 weeks of treatment, and at a follow-up visit at 36 weeks. Data will be analysed in accordance with a predefined statistical analysis plan.

Ethics and dissemination

The Danish Ethics Committee (S-20170217), the Danish Medicines Agency (S-2018010018) and the Danish Data Protection Agency approved the protocol. The project is registered in the European Clinical Trials Database (EudraCT 2017-004226-15). All participants will give written informed consent to participate prior to any study-related procedures. The results will be presented at international conferences and published in peer-reviewed journals.

Can goal-setting for patients with multimorbidity improve outcomes in primary care? Cluster randomised feasibility trial

Por: Ford · J. A. · Lenaghan · E. · Salter · C. · Turner · D. · Shiner · A. · Clark · A. B. · Murdoch · J. · Green · C. · James · S. · Koopmans · I. · Lipp · A. · Moseley · A. · Wade · T. · Winterburn · S. · Steel · N.

Goal-setting is recommended for patients with multimorbidity, but there is little evidence to support its use in general practice.


To assess the feasibility of goal-setting for patients with multimorbidity, before undertaking a definitive trial.

Design and setting

Cluster-randomised controlled feasibility trial of goal-setting compared with control in six general practices.


Adults with two or more long term health conditions and at risk of unplanned hospital admission.


General practitioners (GPs) underwent training and patients were asked to consider goals before an initial goal-setting consultation and a follow-up consultation 6 months later. The control group received usual care planning.

Outcome measures

Health-related quality of life (EQ-5D-5L), capability (ICEpop CAPability measure for Older people), Patient Assessment of Chronic Illness Care and healthcare use. All consultations were video-recorded or audio-recorded, and focus groups were held with participating GPs and patients.


Fifty-two participants were recruited with a response rate of 12%. Full follow-up data were available for 41. In the goal-setting group, mean age was 80.4 years, 54% were female and the median number of prescribed medications was 13, compared with 77.2 years, 39% female and 11.5 medications in the control group. The mean initial consultation time was 23.0 min in the goal-setting group and 19.2 in the control group. Overall 28% of patient participants had no cognitive impairment. Participants set between one and three goals on a wide range of subjects, such as chronic disease management, walking, maintaining social and leisure interests, and weight management. Patient participants found goal-setting acceptable and would have liked more frequent follow-up. GPs unanimously liked goal-setting and felt it delivered more patient-centred care, and they highlighted the importance of training.


This goal-setting intervention was feasible to deliver in general practice. A larger, definitive study is needed to test its effectiveness.

Trial registration number

ISRCTN13248305; Post-results.

Suicide in Canadian veterans living in Ontario: a retrospective cohort study linking routinely collected data

Por: Mahar · A. L. · Aiken · A. B. · Whitehead · M. · Tien · H. · Cramm · H. · Fear · N. T. · Kurdyak · P.

To compare the risk of death by suicide in male veterans with age-matched civilians.


Retrospective cohort study linking provincial administrative databases between 1990 and 2013 with follow-up complete until death or December 31, 2015.


Population-based study in Ontario, Canada.


Ex-serving Canadian Armed Forces and Royal Canadian Mounted Police veterans living in Ontario who registered for provincial health insurance were included. A civilian comparator group was matched 4:1 on age and sex.

Main outcome

Death by suicide was classified using standard cause of death diagnosis codes from a provincial registry of mandatory data collected from death certificates. Fine and Gray sub-distribution hazards regression compared the risk of death by suicide between veterans and civilians. Analyses were adjusted for age, residential region, income, rurality and major physical comorbidities.


20 397 male veterans released to Ontario between 1990 and 2013 and 81 559 age–sex matched civilians were included. 4.2% of veterans died during the study time frame, compared with 6.5% of the civilian cohort. Death by suicide was rare in both cohorts, accounting for 4.6% and 3.6% of veteran and civilian deaths, respectively. After adjustment for confounders, veterans had an 18% lower risk of dying from causes other than suicide (HR 0.82, 95% CI 0.76 to 0.89) and a similar risk of dying by suicide (HR 1.01, 95% CI 0.71 to 1.43), compared with civilians.


Deaths by suicide were rare in male veterans residing in Ontario. Our findings demonstrate that veterans had a similar risk of suicide-related mortality as an age-matched civilian population. A better understanding of effective suicide prevention as well as clarifying pathways to seeking and receiving mental health supports and services are important areas for future consideration.

Substituting hospital-based outpatient cardiology care: The impact on quality, health and costs

by Tessa C. C. Quanjel, Marieke D. Spreeuwenberg, Jeroen N. Struijs, Caroline A. Baan, Dirk Ruwaard


Many Western countries face the challenge of providing high-quality care while keeping the healthcare system accessible and affordable. In an attempt to deal with this challenge a new healthcare delivery model called primary care plus (PC+) was introduced in the Netherlands. Within the PC+ model, medical specialists perform consultations in a primary care setting. PC+ aims to support the general practitioners in gatekeeping and prevent unnecessary referrals to hospital care. The aim of this study was to examine the effects of a cardiology PC+ intervention on the Triple Aim outcomes, which were operationalized by patient-perceived quality of care, health-related quality of life (HRQoL) outcomes, and healthcare costs per patient.


This is a quantitative study with a longitudinal observational design. The study population consisted of patients, with non-acute and low-complexity cardiology-related health complaints, who were referred to the PC+ centre (intervention group) or hospital-based outpatient care (control group; care-as-usual). Patient-perceived quality of care and HRQoL (EQ-5D-5L, EQ-VAS and SF-12) were measured through questionnaires at three different time points. Healthcare costs per patient were obtained from administrative healthcare data and patients were followed for nine months. Chi-square tests, independent t-tests and multilevel linear models were used to analyse the data.


The patient-perceived quality of care was significantly higher within the intervention group for 26 out of 27 items. HRQoL outcomes did significantly increase in both groups (P Conclusions

While this study showed no improvements on HRQoL outcomes, PC+ seemed to be promising as it results in improved quality of care as experienced by patients and lower healthcare costs per patient.

National health information systems for achieving the Sustainable Development Goals

Por: Suthar · A. B. · Khalifa · A. · Joos · O. · Manders · E.-J. · Abdul-Quader · A. · Amoyaw · F. · Aoua · C. · Aynalem · G. · Barradas · D. · Bello · G. · Bonilla · L. · Cheyip · M. · Dalhatu · I. T. · De Klerk · M. · Dee · J. · Hedje · J. · Jahun · I. · Jantaramanee · S. · Kamocha · S. · Lereb

Achieving the Sustainable Development Goals will require data-driven public health action. There are limited publications on national health information systems that continuously generate health data. Given the need to develop these systems, we summarised their current status in low-income and middle-income countries.


The survey team jointly developed a questionnaire covering policy, planning, legislation and organisation of case reporting, patient monitoring and civil registration and vital statistics (CRVS) systems. From January until May 2017, we administered the questionnaire to key informants in 51 Centers for Disease Control country offices. Countries were aggregated for descriptive analyses in Microsoft Excel.


Key informants in 15 countries responded to the questionnaire. Several key informants did not answer all questions, leading to different denominators across questions. The Ministry of Health coordinated case reporting, patient monitoring and CRVS systems in 93% (14/15), 93% (13/14) and 53% (8/15) of responding countries, respectively. Domestic financing supported case reporting, patient monitoring and CRVS systems in 86% (12/14), 75% (9/12) and 92% (11/12) of responding countries, respectively. The most common uses for system-generated data were to guide programme response in 100% (15/15) of countries for case reporting, to calculate service coverage in 92% (12/13) of countries for patient monitoring and to estimate the national burden of disease in 83% (10/12) of countries for CRVS. Systems with an electronic component were being used for case reporting, patient monitoring, birth registration and death registration in 87% (13/15), 92% (11/12), 77% (10/13) and 64% (7/11) of responding countries, respectively.


Most responding countries have a solid foundation for policy, planning, legislation and organisation of health information systems. Further evaluation is needed to assess the quality of data generated from systems. Periodic evaluations may be useful in monitoring progress in strengthening and harmonising these systems over time.

The skin transcriptome in hidradenitis suppurativa uncovers an antimicrobial and sweat gland gene signature which has distinct overlap with wounded skin

by Margaret Coates, Paula Mariottoni, David L. Corcoran, Hélène Fradin Kirshner, Tarannum Jaleel, David A. Brown, Stephen R. Brooks, John Murray, Maria I. Morasso, Amanda S. MacLeod

Hidradenitis suppurativa (HS) is a debilitating chronic inflammatory skin disease resulting in non-healing wounds affecting body areas of high hair follicle and sweat gland density. The pathogenesis of HS is not well understood but appears to involve dysbiosis-driven aberrant activation of the innate immune system leading to excessive inflammation. Marked dysregulation of antimicrobial peptides and proteins (AMPs) in HS is observed, which may contribute to this sustained inflammation. Here, we analyzed HS skin transcriptomes from previously published studies and integrated these findings through a comparative analysis with a published wound healing data set and with immunofluorescence and qPCR analysis from new HS patient samples. Among the top differently expressed genes between lesional and non-lesional HS skin were members of the S100 family as well as dermcidin, the latter known as a sweat gland-associated AMP and one of the most downregulated genes in HS lesions. Interestingly, many genes associated with sweat gland function, such as secretoglobins and aquaporin 5, were decreased in HS lesional skin and we discovered that these genes demonstrated opposite expression profiles in healing skin. Conversely, HS lesional and wounded skin shared a common gene signature including genes encoding for S100 proteins, defensins, and genes encoding antiviral proteins. Overall, our results suggest that the pathogenesis of HS may be driven by changes in AMP expression and altered sweat gland function, and may share a similar pathology with chronic wounds.