BMJ Open

Bilsteen, Josephine Funck; Andresen, Josefine Bernhard; Mortensen, Laust Hvas; Hansen, Anne Vinkel; Andersen, Anne-Marie Nybo

doi: 10.1136/bmjopen-2018-023531pmid: 30413512

ObjectiveTo investigate socioeconomic differences in six perinatal health outcomes in Denmark in the first decade of the 21st century.DesignA population-based cohort study.SettingDanish national registries.ParticipantsA total of 646 829 live born children and 3076 stillborn children (≥22+0 weeks of gestation) born in Denmark from 2000 to 2009. We excluded children with implausible relations between birth weight and gestational age (n=644), children without information on maternal country of origin (n=138) and implausible values of maternal year of birth (n=36).Main outcome measuresWe investigated the following perinatal health outcomes: stillbirth, neonatal and postneonatal mortality, small-for-gestational age, preterm birth grated into moderate preterm, very preterm and extremely preterm, and congenital anomalies registered in the first year of life.ResultsMaternal educational level was inversely associated with all adverse perinatal outcomes. For all examined outcomes, the risk association displayed a clear gradient across the educational levels. The associations remained after adjustment for maternal age, maternal country of origin and maternal year of birth. Compared with mothers with vocational education, mothers with more than 15 years of education had an adjusted risk ratio for stillbirth of 0.64(95% CI 0.56 to 0.72). The corresponding adjusted risk ratios for neonatal mortality, postneonatal mortality, congenital anomalies, moderate preterm birth and small-for-gestational age were, respectively, 0.79(95% CI 0.67 to 0.93), 0.57(95% CI 0.42 to 0.78), 0.87(95% CI 0.83 to 0.91), 0.80(95% CI 0.77 to 0.83) and 0.83(95% CI 0.81 to 0.85).ConclusionSubstantial educational inequalities in perinatal health were still present in Denmark in the first decade of the 21st century.

Berrevoets, Marvin A H; Oerlemans, Anke J M; Tromp, Mirjam; Kullberg, Bart Jan; ten Oever, Jaap; Schouten, Jeroen A; Hulscher, Marlies E

doi: 10.1136/bmjopen-2018-024564pmid: 30420352

ObjectivesCurrent outpatient parenteral antimicrobial therapy (OPAT) guidelines recommend delivering patient-centred care. However, little is known about what patients define as good quality of OPAT care and what their needs and preferences are.The aim of this qualitative study is to explore the patients’ perspective on high-quality care, and to explore what patient-centred care means to adult OPAT patients.Design and settingThis is an explorative, descriptive study using qualitative methods. We conducted focus group interviews with 16 adult patients (5 female, 11 male) from 3 different hospitals, who received OPAT and 2 individual semistructured interviews with their informal caregivers in the Netherlands. We used purposive sampling to ensure diversity of participants. We used the eight Picker principles of patient-centredness to guide data collection and analysis.ResultsParticipants reported several elements considered as important for patient-centred OPAT care, like patient involvement in the decision-making process, a responsible OPAT lead, intensive collaboration between all disciplines involved, information provision and adherence to hygiene guidelines. Two central dimensions emerged as essential constituents of patient-centred OPAT care: freedom and safety. Both are heavily influenced by the behaviours of healthcare professionals and by organisational aspects beyond the direct influence of these professionals.ConclusionThis study provides insights into the needs and preferences of adult patients who receive OPAT care. Future interventions directed at the improvement of patient-centredness of OPAT care should focus on elements that enhance patients’ feelings of freedom and safety.

Xu, San San; Alexander, Paschal K; Lie, Yenni; Dore, Vincent; Bozinovski, Svetlana; Mulligan, Rachel S; Young, Kenneth; Villemagne, Victor L; Rowe, Christopher C

doi: 10.1136/bmjopen-2018-025533pmid: 30446576

ObjectivesTo further validate the diagnostic utility of 18F-AV-133 vesicular monoamine transporter type 2 (VMAT2) positron emission tomography (PET) in patients with clinically uncertain parkinsonian syndromes (CUPS) by comparison to clinical diagnosis at 3 years follow-up.Design, setting and participantsIn a previous study, we reported that 18F-AV-133 PET in community patients with CUPS changed diagnosis and management and increased diagnostic confidence. The current diagnosis of this cohort was obtained from the patient and treating specialist and compared with the diagnosis suggested 3 years earlier by the 18F-AV-133 PET. A second 18F-AV-133 PET was available in those with a discordant or inconclusive final diagnosis.Study outcome measuresThe primary end point was the proportion of patients who had a follow-up clinical diagnosis, which was concordant with their initial 18F-AV-133 PET scan. Secondary end points were the proportion of patients who had the same diagnosis at follow-up as that reached after the initial scan and the stability of diagnostic changes made after the first scan.Results81 of the 85 patients previously recruited to the CUPS study had follow-up of which 79 had a clinical diagnosis and 2 remained CUPS. The diagnosis was in agreement with the initial 18F-AV-133 PET scan result in 74 cases. Five patients had a discordant diagnosis; one patient with rubral tremor had a severely abnormal scan that had worsened when rescanned; four cases with normal initial and repeat scans had a clinical diagnosis of Parkinson’s disease. Two patients with suspected genetic disorders remained classified as CUPS and both had normal scans. In the 24 CUPS cohort patients where 18F-AV-133 PET initially changed diagnosis, this change was supported by follow-up diagnosis in all but the one rubral tremor case.Conclusion 18F-AV-133 PET is a useful tool in improving diagnostic accuracy in CUPS providing results and diagnostic changes that remain robust after 3 years follow-up.

Yogendrakumar, Vignan; Lun, Ronda; Hutton, Brian; Fergusson, Dean A; Dowlatshahi, Dar

doi: 10.1136/bmjopen-2018-024405pmid: 30397010

IntroductionPatients with an intracerebral haemorrhage are at increased risk of venous thromboembolism. Pharmacotherapy and pneumatic compression devices are capable of preventing venous thromboembolism, however both interventions have limitations. There are no head-to-head comparisons between these two interventions. To address this knowledge gap, we plan to perform a systematic review and network meta-analysis to examine the comparative effectiveness of pharmacological prophylaxis and mechanical compression devices in the context of intracerebral haemorrhage.Methods and analysisMEDLINE, PUBMED, EMBASE, CENTRAL, ClinicalTrials.gov and the Internet Stroke Trials Registry will be searched with assistance from an experienced information specialist. Eligible studies will include those that have enrolled adults presenting with spontaneous intracerebral haemorrhage and compared one or more of the respective interventions against each other and/or a control. Primary outcomes to be assessed are occurrence of new venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) and haematoma expansion, defined as a significant enlargement of baseline haemorrhage or new haemorrhage occurrence. Both randomised and non-randomised comparative studies will be included. Data on participant characteristics, study design, intervention details and outcomes will be extracted. Study quality will be assessed using the Cochrane Risk of Bias Tool and the Robins-I tool. Bayesian network meta-analyses will be performed to compare interventions based on all available direct and indirect evidence. If the transitivity assumption for network meta-analysis cannot be met, we will perform a qualitative assessment.Ethics and disseminationFormal ethics is not required as primary data will not be collected. The findings of this study will be disseminated through conference presentations, and peer-reviewed publications. In an area of clinical practice where equipoise exists, the findings of this study may assist in determining which treatment intervention is most effective in venous thromboembolism prevention.PROSPERO registration numberCRD42018090960.

Chen, Shan; Wang, Siyou; Xuan, Lihua; Lu, Hanti; Hu, Zhikai; Zhang, Chao; Zhang, Huifang

doi: 10.1136/bmjopen-2018-021783pmid: 30397007

IntroductionElectroacupuncture at ‘four sacral points’, also known as electrical pudendal nerve stimulation therapy, combines the advantages of pudendal nerve neuromodulation and the technique of deep insertion of long acupuncture needles. It has been used to treat stress urinary incontinence, female urgency-frequency syndrome, idiopathic urgency urinary incontinence and neurological bladders in previous studies. Here, we describe the protocol for a randomised controlled trial for evaluation of the efficacy and safety of electroacupuncture at ‘four sacral points’ for the management of urinary incontinence after stroke.Methods and analysisThis is an open-label randomised controlled trial with blinded assessments and analyses. A total of 140 eligible patients will be randomly allocated to two groups. The treatment group (n=70) will receive electroacupuncture at ‘four sacral points’ along with routine medical care, while the control group will receive conventional electroacupuncture along with routine medical care. Twenty treatment sessions will occur over a period of 4 weeks. The primary outcome measures will be the self-recorded findings in an incontinent episode diary at baseline and at 4 weeks after baseline. The secondary outcome measures will be the International Consultation on Incontinence Questionnaire Urinary Incontinence—Short Form (ICIQ-UI SF) score and the Barthel Activities of Daily Living Index (Barthel ADL Index) score at baseline and at 4 and 28 weeks after baseline.Ethics and disseminationThis protocol has been approved by the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (approval No. 2018-K-059–01). Written informed consent will be obtained from each participant. The results of the study will be published in peer-reviewed journals.Trial registration numberChiCTR-IOR-17012847; Pre-result.

Shiyanbola, Olayinka O; Unni, Elizabeth; Huang, Yen-Ming; Lanier, Cameron

doi: 10.1136/bmjopen-2018-022803pmid: 30478112

ObjectivesTo cluster the adherence behaviours of patients with type 2 diabetes based on their beliefs in medicines and illness perceptions and examine the psychosocial, clinical and sociodemographic characteristics of patient clusters.DesignCross-sectional study.SettingA face-to-face survey was administered to patients at two family medicine clinics in the Midwest, USA.ParticipantsOne hundred and seventy-four ≥20-year-old, English-speaking adult patients with type 2 diabetes who were prescribed at least one oral diabetes medicine daily were recruited using convenience sampling.Primary and secondary outcome measuresBeliefs in medicines and illness perceptions were assessed using the Beliefs about Medicines Questionnaire and the Brief Illness Perception Questionnaire, respectively. Self-reported medication adherence was assessed using the Morisky Medication Adherence Scale. Psychosocial correlates of adherence, health literacy and self-efficacy were measured using the Newest Vital Sign and the Self-efficacy for Appropriate Medication Use, respectively. Two-step cluster analysis was used to classify patients.ResultsParticipants’ mean age was 58.74 (SD=12.84). The majority were women (57.5%). Four clusters were formed (non-adherent clusters: ambivalent and sceptical; adherent clusters: indifferent and accepting). The ambivalent cluster (n=30, 17.2%) included low-adherent patients with high necessity beliefs, high concern beliefs and high illness perceptions. The sceptical cluster (n=53, 30.5%) included low adherent patients with low necessity beliefs but high concern beliefs and high illness perceptions. Both the accepting (n=40, 23.0%) and indifferent (n=51, 29.3%) clusters were composed of patients with high adherence. Significant differences between the ambivalent, sceptical, accepting and indifferent adherent clusters were based on self-efficacy, illness perception domains (treatment control and coherence) and haemoglobin A1c (p<0.01).ConclusionsPatients with diabetes in specific non-adherent and adherent clusters still have distinct beliefs as well as psychosocial characteristics that may help providers target tailored medication adherence interventions.

Wheeler, Amanda J; Spinks, Jean; Kelly, Fiona; Ware, Robert S; Vowles, Erica; Stephens, Mike; Scuffham, Paul A; Miller, Adrian

doi: 10.1136/bmjopen-2018-026462pmid: 30391923

IntroductionThe age-adjusted rate of potentially preventable hospitalisations for Aboriginal and Torres Strait Islander people is almost five times the rate of other Australians. Quality use of medicines has an important role in alleviating these differences. This requires strengthening existing medication reviewing services through collaboration between community pharmacists and health workers, and ensuring services are culturally appropriate. This Indigenous Medication Review Service (IMeRSe) study aims to develop and evaluate the feasibility of a culturally appropriate medication management service delivered by community pharmacists in collaboration with Aboriginal health workers.Methods and analysisThis study will be conducted in nine Aboriginal health services (AHSs) and their associated community pharmacies in three Australian states over 12 months. Community pharmacists will be trained to improve their awareness and understanding of Indigenous health and cultural issues, to communicate the quality use of medicines effectively, and to strengthen interprofessional relationships with AHSs and their staff. Sixty consumers (with a chronic condition/pregnant/within 2 years post partum and at risk of medication-related problems (MRPs) per site will be recruited, with data collection at baseline and 6 months. The primary outcome is the difference in cumulative incidence of serious MRPs in the 6 months after IMeRSe introduction compared with the 6 months prior. Secondary outcomes include potentially preventable medication-related hospitalisations, medication adherence, total MRPs, psychological and social empowerment, beliefs about medication, treatment satisfaction and health expenditure.Ethics and disseminationThe protocol received approval from Griffith University (HREC/2018/251), Queensland Health Metro South (HREC/18/QPAH/109), Aboriginal Health and Medical Research Council of New South Wales (1381/18), Far North Queensland (HREC/18/QCH/86-1256) and the Central Australian HREC (CA-18-3090). Dissemination to Indigenous people and communities will be a priority. Results will be available on the Australian Sixth Community Pharmacy Agreement website and published in peer-reviewed journals.Trial registration numberACTRN12618000188235; Pre-results.

Cockayne, Sarah; Fairhurst, Caroline; Frost, Gillian; Hewitt, Catherine; Liddle, Mark; Zand, Michael; Iles-Smith, Heather; Green, Lorraine; Cunningham-Burley, Rachel; Torgerson, David

doi: 10.1136/bmjopen-2018-026023pmid: 30446577

IntroductionSlips, trips and falls are common causes of injuries in the workplace. It is estimated that in Great Britain, nearly 1 million days are taken off work due to these injuries. There is some evidence to suggest this accident burden could be reduced by the use of slip resistant footwear. This protocol describes a multicentre trial investigating the effectiveness and cost-effectiveness of slip resistant footwear to prevent slips in National Health Service (NHS) staff working in clinical, general or catering environments.Methods and analysisA two-arm, randomised controlled trial conducted within England, with 4400 NHS staff, aged 18 years and above, who adhere to a dress code policy and work in a clinical, catering or general hospital environment. Participants will be randomised 1:1 to the intervention or waiting list control group. The intervention group will be offered a pair of 5-star GRIP rated slip resistant footwear. The control group will be offered the footwear at the end of the trial. The primary outcome is the incidence rate of self-reported slips in the workplace over a 14-week period, as reported via weekly text messages. Secondary outcomes include: time to first slip/fall, proportion of participants who slip and fall over 14 weeks and incidence rate of falls resulting from and not resulting from a slip in the workplace over 14 weeks. An economic evaluation will assess cost-effectiveness, in terms of cost per quality-adjusted life year gained. A nested qualitative study will explore the acceptability of the footwear and compliance.Ethics and disseminationThis protocol received a favourable ethical opinion from the University of York, Department of Health Sciences Research Governance Committee. The trial results will be published in peer-reviewed journals and at conferences. A summary of the findings will be made available to participants.Trial registration number ISRCTN33051393; Pre results.

Nero, Håkan; Ranstam, Jonas; Kiadaliri, Aliasghar Ahmad; Dahlberg, Leif E

doi: 10.1136/bmjopen-2018-022925pmid: 30413507

IntroductionDespite favourable results from structured face-to-face treatment of osteoarthritis (OA) in Sweden through the Better management of patients with OsteoArthritis (BOA) initiative, only around 20% of people with knee or hip OA receive the primary treatment recommended by international guidelines (ie, information, exercise, weight management). In 2014, a digital treatment programme named Joint Academy was introduced in Sweden, based on the same concept as the face-to-face BOA programme. In line with BOA, Joint Academy follows national and international guidelines and best practice for OA treatment. Results from observational studies suggest that this digital treatment is a valuable alternative to the traditional treatment approach and can positively impact patients’ function and pain. However, conclusions from such studies commonly suggest that more rigorous testing is necessary to ascertain the benefits of digital treatment delivery for people with OA.Methods and analysisA randomised clinical trial will be performed, comparing regular face-to-face care according to BOA with the digital version, Joint Academy. A total of 270 participants with clinically diagnosed knee OA will be recruited at primary care centres and randomised to either standard treatment (BOA) for 3 months, or the experimental group (digital intervention programme). Both groups will receive educational sessions and exercises yet with a difference in programme deliverance. The objective of the trial is to evaluate the effectiveness of the online treatment programme, in comparison with BOA. The two treatment groups will be compared with respect to the number of repetitions of the 30 s chair stand test at 3, 6 and 12 months, using a mixed model repeated measures analysis of variance.Ethics and disseminationEthical approval has been attained from the Regional Board of Ethics in Lund, Sweden (Dnr 2017/719). Results will be published in peer-reviewed journals.Trial registration number NCT03328741.

Skinner, Mark W; Herron, Rachel V; Bar, Rachel J; Kontos, Pia; Menec, Verena

doi: 10.1136/bmjopen-2018-026912pmid: 30498050

IntroductionThis study examines the potential of dance to improve social inclusion for people living with dementia and carers. Research suggests that arts-based programmes can improve the health of people living with dementia and carers; however, little is known about how these programmes might address barriers to social inclusion. Addressing barriers requires the development and evaluation of accessible, non-stigmatising and affordable programmes that facilitate social inclusion across the continuum of institutional, community and household care settings.Methods and analysisThe study involves a qualitative sequential pilot study of the innovative Baycrest NBS Sharing Dance Seniors programme underway in non-metropolitan regions of two Canadian provinces. It focuses on the remotely instructed delivery of the programme in care facilities, community centres and households. The study involves five phases of observations, diaries, focus groups and interviews with programme participants (people living with dementia), carers, coordinators, instructors and volunteers as well as critical reflections among research investigators and knowledge users. NVivo-based thematic and narrative analyses of the qualitative data will produce new knowledge about the experiences, effectiveness and challenges of the dance programme that will inform understanding of whether and in what ways it increases social inclusion and quality of life for older people living with dementia and carers. The findings will identify opportunities for programme expansion and support the further development of arts-based approaches.Ethics and disseminationThe study is approved by the Research Ethics Boards at Trent University and Brandon University, and by participating organisations according to their governance procedures. The perspectives of people living with dementia and carers are incorporated throughout the study (from design to dissemination) and the study adheres to the ethical considerations when including people with dementia. A series of publicly available reports, seminars and symposia will be undertaken in collaboration with knowledge user and collaborating organisation partners.