BMJ Open

Adom, Theodosia; Puoane, Thandi; De Villiers, Anniza; Kengne, André Pascal

doi: 10.1136/bmjopen-2016-013540pmid: 28348187

IntroductionThe increasing prevalence of obesity and overweight in childhood in developing countries is a public health concern to many governments. Schools play a significant role in the obesity epidemic as well as provide favourable environments for change in behaviours in childhood which can be carried on into adulthood. There is dearth of information on intervention studies in poor-resource settings. This review will summarise the available evidence on school-based interventions that focused on promoting healthy eating and physical activity among learners aged 6–15 years in Africa and to identify factors that lead to successful interventions or potential barriers to success of these programmes within the African context.Methods and analysisThis protocol is developed following the guidelines of PRIMSA-P 2015. Relevant search terms and keywords generated from the subject headings and the African search filter will be used to conduct a comprehensive search of MEDLINE (PubMed), MEDLINE (EbscoHost), CINAHL (EbscoHost), Register Academic Search Complete (EbscoHost) and ISI Web of Science (Science Citation Index) for published literature on school-based interventions to prevent and control obesity in learners in Africa. Grey literature will be also be obtained. The searches will cover 1 January 2000 to 30 June 2016. No language limitations will be applied. Full-text articles of eligible studies will be screened. Risk of bias and quality of reporting will be assessed. Data will be extracted, synthesised and presented by country and major regional groupings. Meta-analysis will be conducted for identical variables across studies, where data allow. This protocol is developed following the guidelines of PRISMA-P 2015.Ethics and disseminationNo primary data will be collected hence ethics is not a requirement. The findings will be submitted for publication in peer-reviewed journals, in conferences and in policy documents for decision-making, where needed.

Gregory, Alison; Feder, Gene; Taket, Ann; Williamson, Emma

doi: 10.1136/bmjopen-2016-014511pmid: 28341690

ObjectivesDomestic violence (DV) is hazardous to survivors' health, from injuries sustained and from resultant chronic physical and mental health problems. Support from friends and relatives is significant in the lives of DV survivors; research shows associations between positive support and the health, well-being and safety of survivors. Little is known about how people close to survivors are impacted. The aim of this study was exploratory, with the following research question: what are the health and well-being impacts on adults who provide informal support to female DV survivors?DesignA qualitative study using semistructured interviews conducted face to face, by telephone or using Skype. A thematic analysis of the narratives was carried out.SettingCommunity-based, across the UK.ParticipantsPeople were eligible to take part if they had had a close relationship (either as friend, colleague or family member) with a woman who had experienced DV, and were aged 16 or over during the time they knew the survivor. Participants were recruited via posters in community venues, social media and radio advertisement. 23 participants were recruited and interviewed; the majority were women, most were white and ages ranged from mid-20s to 80.ResultsGenerated themes included: negative impacts on psychological and emotional well-being of informal supporters, and related physical health impacts. Some psychological impacts were over a limited period; others were chronic and had the potential to be severe and enduring. The impacts described suggested that those providing informal support to survivors may be experiencing secondary traumatic stress as they journey alongside the survivor.ConclusionsFriends and relatives of DV survivors experience substantial impact on their own health and well-being. There are no direct services to support this group. These findings have practical and policy implications, so that the needs of informal supporters are legitimised and met.

Ravani, Pietro; Bonanni, Alice; Ghiggeri, Gian Marco

doi: 10.1136/bmjopen-2016-013319pmid: 28314744

IntroductionOral steroids induce remission in about 90% of children with idiopathic nephrotic syndrome (INS), which is characterised by severe proteinuria and hypoalbuminaemia. Some children become steroid-dependent (SD) and require addition of calcineurin inhibitors (CNI) to maintain remission. Since these oral agents are toxic, alternative interventions are needed for long-term treatment. The anti-CD20 antibody rituximab has shown promising steroid-sparing properties in clinical trials, but benefits are less convincing in complicated forms of SD-INS. Ofatumumab, a new anti-CD20 antibody with stronger affinity to CD20, may be superior to rituximab in maintaining oral steroid-free and CNI-free disease remission in children with SD-INS.Methods and analysisThis open-label, two-parallel-arm, controlled, phase II randomised clinical trial will enrol children with SD-INS maintained in remission with oral steroids and CNI. Children will be randomised to either ofatumumab or rituximab infusion. After infusion of either antibody, steroids will be maintained for 30 days and then tapered off by 0.3 mg/kg/week until complete withdrawal. 1 week after complete steroid withdrawal, CNI will be decreased by 50% and withdrawn within 2 additional weeks. We will enrol 140 children to detect as significant at the 2-sided p value of 0.01 with a power of >0.8, a reduction in the risk of 1-year relapse (primary end point) of at least 0.3 (ie, from 0.65 to 0.35; (risk ratio 0.54)) in the ofatumumab arm when compared with the rituximab arm. We will compare the amount of steroids required to maintain complete disease remission at 6 and 24 months, relapse-free period, relapse rate per year as secondary end points. Circulating cell populations will be studied as biomarkers or predictors of the anti-CD20 response.Ethics and disseminationThe trial received ethics approval from the local ethics board. We will publish study results and present them at international scientific meetings.Trial registration numbersNCT02394119; 2015-000624-28; Pre-results.

Ambrose, Kathlin K; Ishak, Taufik; Lian, Lay-Hoong; Goh, Khean-Jin; Wong, Kum-Thong; Ahmad-Annuar, Azlina; Thong, Meow-Keong

doi: 10.1136/bmjopen-2015-010711pmid: 28363916

ObjectiveThe lack of epidemiological data and molecular diagnostic services in Malaysia has hampered the setting-up of a comprehensive management plan for patients with myotonic dystrophy type 1 (DM1), leading to delayed diagnosis, treatment and support for patients and families. The aim of this study was to estimate the prevalence of DM1 in the 3 major ethnic groups in Malaysia and evaluate the feasibility of a single tube triplet-primed PCR (TP-PCR) method for diagnosis of DM1 in Malaysia.Design, setting and participantsWe used PCR to determine the size of CTG repeats in 377 individuals not known to be affected by DM and 11 DM1 suspected patients, recruited from a tertiary hospital in Kuala Lumpur. TP-PCR was performed on selected samples, followed by Southern blot hybridisation of PCR amplified fragments to confirm and estimate the size of CTG expansion.Outcome measuresThe number of individuals not known to be affected by DM with (CTG)>18 was determined according to ethnic group and as a whole population. The χ2 test was performed to compare the distribution of (CTG)>18 with 12 other populations. Additionally, the accuracy of TP-PCR in detecting CTG expansion in 11 patients with DM1 was determined by comparing the results with that from Southern blot hybridisation.ResultsOf the 754 chromosomes studied, (CTG)>18 frequency of 3.60%, 1.57% and 4.00% in the Malay, Chinese and Indian subpopulations, respectively, was detected, showing similarities to data from Thai, Taiwanese and Kuwaiti populations. We also successfully detected CTG expansions in 9 patients using the TP-PCR method followed by the estimation of CTG expansion size via Southern blot hybridisation.ConclusionsThe results show a low DM1 prevalence in Malaysia with the possibility of underdiagnosis and demonstrates the feasibility of using a clinical and TP-PCR-based approach for rapid and cost-effective DM1 diagnosis in developing countries.

Horne, Kerry L; Packington, Rebecca; Monaghan, John; Reilly, Timothy; Selby, Nicholas M

doi: 10.1136/bmjopen-2016-015316pmid: 28360257

ObjectivesUsing a prospective study design, we aimed to characterise the effect of acute kidney injury (AKI) on long-term changes in renal function in a general hospital population.ParticipantsHospitalised patients with AKI (exposed) and hospitalised patients without AKI (non-exposed), recruited at 3 months after hospital admission.DesignProspective, matched parallel group cohort study, in which renal function and proteinuria were measured at 3 months, 1 year and 3 years.SettingSingle UK centre.Clinical end pointsClinical end points at 3 years were comparison of the following variables between exposed and non-exposed groups: renal function, prevalence of proteinuria and albuminuria and chronic kidney disease (CKD) progression/development at each time point. CKD progression was defined as a decrease in the estimated glomerular filtration rate (eGFR) of ≥25% associated with a decline in eGFR stage.Results300 exposed and non-exposed patients were successfully matched 1:1 for age and baseline renal function; 70% of the exposed group had AKI stage 1. During follow-up, the AKI group had lower eGFR than non-exposed patients at each time point. At 3 years, the mean eGFR was 60.7±21 mL/min/1.73 m2 in the AKI group compared with 68.4±21 mL/min/1.73 m2 in the non-exposed group, p=0.003. CKD development or progression at 3 years occurred in 30 (24.6%) of the AKI group compared with 10 (7.5%) of the non-exposed group, p<0.001. Albuminuria was more common in the AKI group, and increased with AKI severity. Factors independently associated with CKD development/progression after AKI were non-recovery at 90 days, male gender, diabetes and recurrent AKI.ConclusionsAKI is associated with deterioration in renal function to 3 years, even in an unselected population with predominantly AKI stage 1. Non-recovery from AKI is an important factor determining long-term outcome.

Gundersen, Guri H; Norekvål, Tone M; Graven, Torbjørn; Haug, Hilde H; Skjetne, Kyrre; Kleinau, Jens O; Gustad, Lise T; Dalen, Håvard

doi: 10.1136/bmjopen-2016-013734pmid: 28320791

ObjectivesWe aimed to study whether patient-reported outcomes, measured by quality of life (QoL) and functional class, are sensitive to pleural effusion (PLE) in patients with heart failure (HF), and to study changes in QoL and functional class during follow-up of PLE.MethodsA cohort of 62 patients from an outpatient HF clinic was included. The amount of PLE was quantified using a pocket-sized ultrasound imaging device. Self-reports of QoL and functional class were collected using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the New York Heart Association (NYHA) functional classification.ResultsAt baseline, 26 (42%) patients had PLE of which 19 (31%) patients had moderate to severe amounts of PLE. Patients with no to mild PLE had a lower MLHFQ score (mean 42, SD 21) compared with patients with a moderate to severe amount of PLE (mean 55, SD 24), p=0.03. For 28 patients (45%) with follow-up data, we observed a linear improvement of the MLHFQ-score (3.2, 95% CI 1.2 to 5.1) with each centimetre reduction of PLE. Correspondingly, patient-reported NYHA-class followed the same pattern as the MLHFQ-score.ConclusionsOur study indicates that patient-reported outcome measures as MLHFQ may be sensitive tools to identify patients with HF at highest risk of symptomatic PLE and that treatment targeting reduction of PLE during follow-up is essential to improvement of QoL and functional capacity of outpatients with HF.Trial registration numberNCT01794715; Results

doi: 10.1136/bmjopen-2016-013786corr1pmid: 28302639

Chiavaroli, Laura; Mirrahimi, Arash; Ireland, Christopher; Mitchell, Sandra; Sahye-Pudaruth, Sandhya; Coveney, Judy; Olowoyeye, Omodele; Patel, Darshna; de Souza, Russell J; Augustin, Livia S A; Bashyam, Balachandran; Pichika, Sathish Chandra; Blanco Mejia, Sonia; Nishi, Stephanie K; Leiter, Lawrence A; Josse, Robert G; McKeown-Eyssen, Gail E; Moody, Alan R;

Ukoumunne, Obioha C; Vaidya, Bijay; Frost, Julia; Anderson, Rob; Argyle, Catherine; Daly, Mark; Harris-Golesworthy, Faith; Harris, Jim; Gibson, Andy; Ingram, Wendy; Pinkney, Jon; Vickery, Jane; Britten, Nicky

doi: 10.1136/bmjopen-2016-013519pmid: 28270389

ObjectiveTo test the feasibility of running a randomised controlled trial of a preconsultation web-based intervention (Presenting Asking Checking Expressing (PACE-D)) to improve the quality of care and clinical outcomes in patients with diabetes.Design and settingA feasibility study (with randomisation) conducted at outpatient diabetes clinics at two secondary care hospitals in Devon, UK.ParticipantsPeople with diabetes (type 1 and type 2) attending secondary care general diabetes outpatient clinics.InterventionThe PACE-D, a web-based tool adapted for patients with diabetes to use before their consultation to generate an agenda of topics to discuss with their diabetologist.OutcomesThe percentage of eligible patients who were recruited and the percentage of participants for whom routine glycosylated haemoglobin (HbA1c) data (the putative primary outcome) could be extracted from medical notes and who completed secondary outcome assessments via questionnaire at follow-up were reported.ResultsIn contrast with the planned recruitment of 120 participants, only 71 participants were randomised during the 7-month recruitment period. This comprised 18.7% (95% CI 14.9% to 23.0%) of those who were eligible. Mean (SD) age of the participants was 56.5 (12.4) years and 66.2% had type 1 diabetes. Thirty-eight patients were randomised to the intervention arm and 33 to the control arm. HbA1c data were available for only 73% (95% CI 61% to 83%) of participants at the 6 months follow-up. The questionnaire-based data were collected for 66% (95% CI 54% to 77%) of the participants at 6 months follow-up. Participants reported that the PACE-D tool was easy to use.ConclusionsA randomised controlled trial of the preconsultation web-based intervention as set out in our current protocol is not feasible without significant modification to improve recruitment and follow-up of participants. The study also provides insights into the feasibility and challenges of conducting complex intervention trials in everyday clinical practice.Trial registrationISRCTN75070242.

doi: 10.1136/bmjopen-2015-009769corr1pmid: 28325861