bluuebunny/crossref_metadata_2025 huggingface dataset:
Suicidal Ideation in Elite Schools: A Test of the Interpersonal Theory and the Escape Theory of Suicide
Authors: Landrault Hélène , Jaafari Nemat , Amine Mohamed , Malka Gabriel , Selimbegović Leila , Chatard Armand
Published: August 2019

Objective

The present study compared the ability of two contemporary theories of suicidal behavior—the interpersonal and escape theories of suicide—to predict suicidal ideation. The interpersonal theory proposes that the interaction of perceived burdensomeness and thwarted belongingness predicts suicidal ideation. The escape theory proposes that feelings of failure predict suicidal ideation and that escape motivation mediates this relationship. The present study intended to determine which of the two theories more successfully explains suicidal ideation.

Method

A sample of 306 students from elite schools in Morocco (193 women, Mage = 21.21 years, predominantly Muslims) completed a questionnaire assessing feelings of failure and escape motivation, perceived burdensomeness and thwarted belongingness, suicide ideation, and control variables.

Results

In line with previous research, separate tests revealed support for the two theories. Interestingly, when entered simultaneously in a multiple regression analysis, the two frameworks explained a unique and cumulative part of the variance in suicidal ideation. Moreover, the effects remained significant after controlling for past suicide attempts, depression, hopelessness, and stress.

Conclusions

The findings suggest that combining the interpersonal and escape theories of suicide could help better explain the emergence of suicidal ideation among college students.
Rescheduling Part 2 of the 11+ reduces injury burden and increases compliance in semi‐professional football
Authors: Whalan Matthew , Lovell Ric , Steele Julie R. , Sampson John A.
Published: August 2019

Although the 11+ program has been shown to reduce injuries in sub‐elite football, program compliance is typically poor, suggesting that strategies to optimize delivery are necessary. This study investigated the effect of rescheduling Part 2 of the three‐part 11+ program on program effectiveness. Twenty‐five semi‐professional football clubs were randomly allocated to either a Standard‐11+ (n = 398 players) or P2post group (n = 408 players). Both groups performed the 11+ program at least twice a week throughout the 2017 football season. The Standard‐11+ group performed the entire 11+ program before training activities commenced, whereas the P2post group performed Parts 1 and 3 of the 11+ program before and Part 2 after training. Injuries, exposure, and individual player 11+ dose were monitored throughout the season. No significant between group difference in injury incidence rate (P2post vs Standard‐11+ = 11.8 vs 12.3 injuries/1000 h) was observed. Severe time loss injuries > 28 days (33 vs 58 injuries; P < .002) and total days lost to injury (4303 vs 5815 days; P < .001) were lower in the P2post group. A higher 11+ program dose was observed in the P2post (29.1 doses; 95% CI 27.9‐30.1) versus Standard‐11+ group (18.9 doses; 95% CI 17.6−20.2; P < .001). In semi‐professional football, rescheduling Part 2 of the 11+ program to the end of training maintained the effectiveness of the original 11+ program to reduce injury incidence. Importantly, rescheduling Part 2 improved player compliance and reduced the number of severe injuries and total injury burden, thereby enhancing effectiveness of the 11+ program.
An open‐label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis
Authors: Marston William A. , Lantis John C. , Wu Stephanie C. , Nouvong Aksone , Lee Tommy D. , McCoy Nicholas D. , Slade Herbert B. , Tseng Scheffer C.
Published: August 2019

Clinical trials of potential new therapies for diabetic foot ulcers rarely enroll patients whose wounds extend to muscle, fascia, or bone with clinical and radiographic evidence of underlying osteomyelitis. An open‐label, multicenter trial of cryopreserved human umbilical cord (TTAX01) was undertaken in 32 subjects presenting with such complex wounds with a mean duration of 6.1 ± 9.0 (range: 0.2–47.1) months and wound area at screening of 3.8 ± 2.9 (range: 1.0–9.6) cm2. Aggressive surgical debridement at baseline resulted in 17 minor amputations and an increase in mean wound area to 7.4 ± 5.8 (range: 1.1–28.6) cm2. All subjects were placed on systemic antibiotics for at least 6 weeks in conjunction with baseline application of TTAX01. Repeat applications were made at no less than 4‐week intervals over the 16‐week trial. Initial closure occurred in 18 of 32 (56%) wounds, with 16 (50%) of these having confirmed closure in 16 weeks with a median of one‐product application. Cases with biopsy confirmed osteomyelitis (n = 20) showed initial closure in 12 (60%) wounds and confirmed closure in 10 (50%) wounds. Four of the five ulcers presenting as recurrences experienced confirmed closure. Mean overall time to healing was 12.8 ± 4.3 weeks. Mean wound area reduction from baseline was 91% for all wounds. Of the 16 wounds without confirmed closure during the 16‐week treatment period, five (31.3%) achieved 99–100% wound area reduction by their final visit. The product was well tolerated. Two minor amputations occurred during the study period due to recurrent or persistent osteomyelitis; however, there were no major amputations.
Delayed mid-basilar artery stenosis following paediatric acute mechanical thrombectomy: a rare complication from a rare case
Authors: Mukherjee Soumya , McCullagh Helen , Goddard Tony , Patankar Tufail
Published: August 2019

There is limited literature on the use of mechanical thrombectomy with stent-retrievers in paediatric stroke, especially in the posterior circulation. We report a paediatric case of acute basilar artery occlusion successfully treated by mechanical thrombectomy using stent-retriever but complicated by delayed basilar artery stenosis. This case emphasises prudent selection of thrombectomy device and meticulous long-term follow-up when employed in paediatric stroke.
A UK reported case of Graves’ disease with thyroid hemiagenesis
Authors: Faulkner Jack , Varadharajan Kiran , Choudhury Natasha
Published: August 2019

We present a rare case of a 31-year-old patient with Graves’ disease with agenesis of the left thyroid lobe. The patient was managed with a right hemithyroidectomy and isthmusectomy as definitively treatment of Graves’ disease. The patient had an uneventful postoperative outcome and the histology was benign and consistent with Graves’ disease. This is a rare case in the literature of Graves’ disease with unilateral thyroid agenesis, and to our knowledge is the first reported case from the UK.
RefractoryBurkholderia cepaciabacteraemia from a consolidation pneumonia lasting more than 7 weeks, successfully treated with systemic antibiotics and nebulised meropenem
Authors: Lim Bryan Albert , Lopez Adelaine , Buensalido Joseph Adrian
Published: August 2019

We present a case of a 55-year-old Filipino man who was transferred from another institution where he was recently diagnosed with Crohn’s disease but not started on any immunosuppressants. He underwent laparoscopic cholecystectomy with T-tube placement a few weeks prior to admission. On workup, abdominal CT scan was unremarkable, but blood cultures on the third hospital day grewBurkholderia cepacia. Antibiotic regimen was shifted to ceftazidime and levofloxacin. The bacteraemia and febrile episodes persisted despite removal of the central line and T tube. White blood cell scan and chest CT scan showed left-sided consolidation pneumonia. Blood cultures continued to growB. cepaciadespite shifting to meropenem and trimethoprim-sulfamethoxazole. Meropenem nebulisation at 250 mg every 12 hours was added to the regimen on the third week then oral minocycline was added on the fourth week due to persistence of bacteraemia. He subsequently developed a small vegetation on the aortic valve, so amikacin was added. Fever lysed on the sixth week, but theB. cepaciabacteraemia persisted, clearing only on the 51st hospital day. The patient was discharged with a plan to continue antibiotics, including meropenem nebulisation, for 6 more weeks. On follow-up, the patient had no recurrence of fever. There was also resolution of consolidation on chest CT scan and disappearance of vegetation on echocardiography.
Treatment of unresectable cutaneous squamous cell carcinoma with pembrolizumab
Authors: Venkatesh Samantha , Al-Haseni Ali , Sahni Debjani
Published: August 2019

Currently, there are few effective therapies for locally advanced and metastatic cutaneous squamous cell carcinoma (cSCC); however, there is recent evidence supporting the use of immunological therapies in cSCC given the typically high mutation burden and association with immunosuppressed states. This report describes a 56-year-old man presenting with synchronous, invasive cSCC on the right temple and right dorsum of the hand deemed unfavourable for surgical resection. The patient was treated with nine infusions of programmed cell death protein 1 (PD-1) inhibitor therapy, pembrolizumab, with clinical and radiographical resolution of his lesions. This case illustrates the potential use of anti-PD-1 antibody as a first-line treatment in the setting of advanced, unresectable cSCC.
Symmetrical drug-related intertriginous and flexural exanthema due to clindamycin
Authors: Cabrera Hernandez Virginia , Gonzalez Afonso Monica , Callero Viera Ariel , Martin-Fernandez Martin Lidon
Published: August 2019

Systemic drug exposure can produce a skin reaction consisting of symmetrical erythema involving the gluteal and intertriginous areas in the absence of systemic involvement.Symmetrical drug-related intertriginous and flexural exanthema (SDRIFE) occurs after systemic exposure to a drug in which the patient was not previously sensitised, either in the first dose or after several doses. The mechanism of SDRIFE is unknown but is hypothesised to be the result of a delayed hypersensitivity response resulting in a cutaneous eruption some days after the exposure to the drug. The diagnosis should be clinical, based on the history and examination, but skin tests can also be performed to confirm sensitisation. But, as always, the gold-standard test is oral provocation. It is important to know this clinical entity to prevent re-exposure to the responsible allergen in the future.
Combined zinc and vitamin B6 deficiency in a patient with diffuse red rash and angular cheilitis 6 years after Roux-en-Y gastric bypass
Authors: Freitas Jared , Bliven Patrick , Case Robert
Published: August 2019

A 39-year-old woman with a history of Roux-en-Y gastric bypass (RYGB) surgery and alcohol use presented with a confluent erythematous rash involving the perineum spreading outward to the abdomen, thighs and lower back. She had angular cheilitis and glossitis. The rash was painful and blistering in scattered areas. She was hypotensive and appeared to be in septic or hypovolemic shock at presentation. Serum levels of zinc and vitamin B6 were critically low and biopsy of her rash returned suggestive of a nutritional deficiency as its source. The rash slowly improved over the following 2 weeks with oral zinc and vitamin B6 replacement. The body rash resembled that of infants born with inherited defects in zinc transporters, referred to as acrodermatitis enteropathica (AE). This case may represent an acquired case of AE in the setting of prior RYGB.
A conventional surgical approach for removal of an ectopic tooth in the nasal cavity
Authors: Gormley Mark , Chahal Ramanjot , Gallacher Nicola , Bell Christopher
Published: August 2019

A 40-year-old female patient presented to ears, nose and throat complaining of cacosmia and discharge from the left maxillary sinus. Her CT scan revealed an ectopic supplemental nasal tooth which could not be removed by nasoendoscopy. Therefore, a conventional intraoral surgical approach was taken. In this case, we discuss the indications for conventional surgical removal of teeth from the nasal cavity when a nasoendoscopic approach is not possible. We highlight the potential pitfalls of both conventional and nasoendoscopic approaches, including some essential considerations when treatment planning these cases.
Time trends and sociodemographic determinants of preterm births in pregnancy cohorts in Matlab, Bangladesh, 1990–2014
Authors: Rahman Anisur , Rahman Monjur , Pervin Jesmin , Razzaque Abdur , Aktar Shaki , Ahmed Jamal Uddin , Selling Katarina Ekholm , Svefors Pernilla , El Arifeen Shams , Persson Lars Åke
Published: August 2019

Introduction

Preterm birth is the major cause of under-five mortality. Population-based data on determinants and proportions of children born preterm are limited, especially from low-income countries. This study aimed at assessing time trends and social, reproductive and environmental determinants of preterm births based on a population-based pregnancy cohort over 25 years in rural Bangladesh.

Methods

In this cohort study in Matlab, a rural area in Bangladesh, we used data from the Health and Demographic Surveillance System from 1990 to 2014. Gestational age at birth was based on the reported last menstrual period and verified by ultrasound assessments. Preterm birth proportions were assessed within strata of social and reproductive characteristics, and time series analysis was performed with decomposition for trend and seasonality. We also determined the prevented fractions of preterm birth reduction associated with social and demographic changes during the follow-up period.

Results

Analyses were based on 63 063 live births. Preterm birth decreased from 29% (95% CI 28.6 to 30.1) in 1990–1994 to 11% (95% CI 10.5 to 11.6) in 2010–2014. Low education, older age and multi-parity were associated with higher proportions of preterm births across the study period. Preterm births had a marked seasonal variation. A rapid increase in women’s educational level and decrease in parity were associated with the decline in preterm births, and 27% of the reduction observed from 1990 to 2014 could be attributed to these educational and reproductive changes.

Conclusion

The reduction in preterm birth was to a large extent associated with the sociodemographic transition, especially changes in maternal education and parity. The persistent seasonal variation in the proportion of preterm birth may reflect the environmental stressors for pregnant women across the study period. Continued investments in girls’ education and family planning programmes may contribute to further reduction of preterm births in Bangladesh.
The impact of patient-held health records on continuity of care among asylum seekers in reception centres: a cluster-randomised stepped wedge trial in Germany
Authors: Straßner Cornelia , Noest Stefan , Preussler Stella , Jahn Rosa , Ziegler Sandra , Wahedi Katharina , Bozorgmehr Kayvan
Published: August 2019

Introduction

The aim of this study was to assess the effectiveness of a patient-held health record (PHR) for asylum seekers on the availability of health-related information.

Methods

An explorative, cluster-randomised stepped-wedge trial with reception centres as unit of randomisation was conducted. All reception centres (n=6) in two large administrative areas in South Germany with on-site health services were included. All physicians working at these centres were invited to participate in the study. The intervention was the implementation of a PHR. The primary outcome was the prevalence of written health-related information. Secondary outcomes were the physicians’ dissatisfaction with the available written information and the prevalence of missing health-related information. All outcomes were measured at the level of patient–physician contacts by means of a standardised questionnaire, and analysed in logistic multi-level regression models.

Results

We obtained data on 2308 patient–physician contacts. The presence of the PHR increased the availability of health-related information (adjusted OR (aOR), 20.3, 95% CI: 12.74 to 32.33), and tended to reduce missing essential information (aOR 0.71, 95% CI: 0.39 to 1.26) and physicians’ dissatisfaction with available information (aOR 0.5, 95% CI: 0.24 to 1.04). The availability of health-related information in the post-intervention period was higher (aOR 4.22, 95% CI: 2.64 to 6.73), missing information (aOR 0.89, 95% CI: 0.42 to 1.88) and dissatisfaction (aOR 0.43, 95% CI: 0.16 to 1.14) tended to be lower compared with the pre-intervention period.

Conclusions

Healthcare planners should consider introducing PHRs in reception centres or comparable facilities. Future research should focus on the impact of PHRs on clinical outcomes and on intersectoral care.

Trial registration

ISRCTN13212716. Registered 24 November 2016. Retrospectively registered.http://www.isrctn.com/ISRCTN13212716
Evaluation of pharmaceutical industry-led access programmes: a standardised framework
Authors: Rockers Peter C , Laing Richard O , Scott Nancy , Ashigbie Paul , Lucca Erin H , Umeh Chukwuemeka Anthony , Wirtz Veronika J
Published: August 2019

Pharmaceutical industry-led access programmes are increasing in number and scope worldwide. We present a new standardised framework for evaluation of these programmes that includes three components: a taxonomy of 11 access programme strategies; a series of logic models, one for each strategy and a set of measurement indicators. The logic models describe pathways of potential programme impact. Concepts relevant across a broad range of strategies were prioritised for inclusion in logic models to ensure consistency and to facilitate synthesis and learning across programmes. Each concept has at least one corresponding measurement indicator with metadata that includes the definition, details on how it should be measured and recommended data sources. The framework establishes a shared language for the collection and reporting of meaningful industry-led access programme information. Broad adoption by programme developers and implementing partners in the for-profit sector and beyond could facilitate shared learning on effective strategies and best practices.
Home-based rehabilitation for heart failure with reduced ejection fraction: mixed methods process evaluation of the REACH-HF multicentre randomised controlled trial
Authors: Frost Julia , Wingham Jennifer , Britten Nicky , Greaves Colin , Abraham Charles , Warren Fiona C , Jolly Kate , Doherty Patrick Joseph , Miles Jackie , Singh Sally J , Paul Kevin , Taylor Rod , Dalal Hasnain
Published: August 2019

Objective

To identify and explore change processes explaining the effects of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention taking account of reach, amount of intervention received, delivery fidelity and patient and caregiver perspectives.

Design

Mixed methods process evaluation parallel to a randomised controlled trial using data from the intervention group (REACH-HF plus usual care).

Setting

Four centres in the UK (Birmingham, Cornwall, Gwent and York).

Participants

People with heart failure with reduced ejection fraction (HFrEF) and their caregivers.

Methods

The REACH-HF intervention consisted of a self-help manual for patients with HFrEF and caregivers facilitated over 12 weeks by trained healthcare professionals. The process evaluation used multimodal mixed methods analysis. Data consisted of audio recorded intervention sessions; demographic data; intervention fidelity scores for intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers.

Outcome measures

Quantitative data: intervention fidelity and number, frequency and duration of intervention sessions received. Qualitative data: experiences and perspectives of intervention participants and caregivers.

Results

Intervention session attendance with facilitators was high. Fidelity scores were indicative of adequate quality of REACH-HF intervention delivery, although indicating scope for improvement in several areas. Intervention effectiveness was contingent on matching the intervention implementation to the concerns, beliefs and goals of participants. Behaviour change was sustained when shared meaning was established. Respondents’ comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life.

Conclusions

By combining longitudinal mixed methods data, the essential ingredients of complex interventions can be better identified, interrogated and tested. This can maximise the clinical application of research findings and enhance the capacity of multidisciplinary and multisite teams to implement the intervention.

Trial registration number

ISRCTN25032672; Pre-results.
GETUG-AFU 31: a phase I/II multicentre study evaluating the safety and efficacy of salvage stereotactic radiation in patients with intraprostatic tumour recurrence after external radiation therapy—study protocol
Authors: Pasquier David , Le Deley Marie-Cécile , Tresch Emmanuelle , Cormier Luc , Duterque Martine , Nenan Soazig , Lartigau Eric
Published: August 2019

Introduction

Prostate cancer is the third most important cancer in terms of mortality in men. No standard local treatment exists for patients with an intraprostatic recurrence after radiotherapy. Stereotatic body radiotherapy (SBRT) could be a curative treatment for local recurrence. The phase I/II primary objective is the selection of the recommended dose for salvage-SBRT and to estimate the efficacy.

Methods and analysis

We plan to perform a multicentre prospective phase I/II study including at least 47 patients. Eligible patients are patients with biochemical recurrence occurring at least 2 years after external radiotherapy for prostatic adenocarcinoma by the Phoenix definition (prostate-specific antigen (PSA) nadir +2 ng/mL) and histologically proven intraprostatic recurrence only (stage T1-T2 on relapse, PSA level ≤10 ng/mL, PSA doubling time >10 months, absence of pelvic or metastatic recurrence proven by choline or PSMA positron emission tomography scan, and pelvic and prostatic assessment by multiparametric MRI). The phase I primary objective is the selection of the recommended dose for salvage-SBRT (5×6, 6×6 or 5×5 Gy) based on dose-limiting toxicity (DLT). The dose of salvage-SBRT will be selected using a time-to-event continual reassessment method based on DLT defined as grade ≥3 gastrointestinal or urinary toxicity or any other grade 4 adverse event. The phase II primary outcome is to estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate (Phoenix definition: increase in serum total PSA ≥2 ng/mL above the nadir). Phase II secondary outcomes are acute and late toxicities, quality of life, clinical progression-free survival defined as the time interval between the date of registration and the date of clinical progression or death irrespective of the cause.

Ethics and dissemination

The study has received ethical approval from the Ethics committee ‘Ile-de-France III’. Academic dissemination will occur through publication and conference presentations.

Trial registration number

NCT03438552
A protocol for a discrete choice experiment: understanding patient medicine preferences for managing chronic non-cancer pain
Authors: Shanahan Marian , Larance Briony , Nielsen Suzanne , Cohen Milton , Schaffer Maria , Campbell Gabrielle
Published: August 2019

Introduction

High rates of chronic non-cancer pain (CNCP), concerns about adverse effects including dependence among those prescribed potent pain medicines, the recent evidence supporting active rather than passive management strategies and a lack of funding for holistic programme have resulted in challenges around decision making for treatment among clinicians and their patients. Discrete choice experiments (DCEs) are one way of assessing and valuing treatment preferences. Here, we outline a protocol for a study that assesses patient preferences for CNCP treatment.

Methods and analysis

A final list of attributes (and their levels) for the DCE was generated using a detailed iterative process. This included a literature review, a focus group and individual interviews with those with CNCP and clinicians who treat people with CNCP. From this process a list of attributes was obtained. Following a review by study investigators including pain and addiction specialists, pharmacists and epidemiologists, the final list of attributes was selected (number of medications, risk of addiction, side effects, pain interference, activity goals, source of information on pain, provider of pain care and out-of-pocket costs). Specialised software was used to construct an experimental design for the survey. The survey will be administered to two groups of participants, those from a longitudinal cohort of patients receiving opioids for CNCP and a convenience sample of patients recruited through Australia’s leading pain advocacy body (Painaustralia) and their social media and website. The data from the two participant groups will be initially analysed separately, as their demographic and clinical characteristics may differ substantially (in terms of age, duration of pain and current treatment modality). Mixed logit and latent class analysis will be used to explore heterogeneity of responses.

Ethics and dissemination

Ethics approval was obtained from the University of New South Wales Sydney Human Ethics committee HC16511 (for the focus group discussions, the one-on-one interviews and online survey) and HC16916 (for the cohort). A lay summary will be made available on the National Drug and Alcohol Research Centre website and Painaustralia’s website. Peer review papers will be submitted, and it is expected the results will be presented at relevant pain management conferences nationally and internationally. These results will also be used to improve understanding of treatment goals between clinicians and those with CNCP.
Effect of high-flow nasal cannula oxygen therapy compared with conventional oxygen therapy in postoperative patients: a systematic review and meta-analysis
Authors: Lu Zhonghua , Chang Wei , Meng Shan-Shan , Zhang Xiwen , Xie Jianfeng , Xu Jing-Yuan , Qiu Haibo , Yang Yi , Guo Fengmei
Published: August 2019

Objective

To evaluate the effect of high-flow nasal cannula oxygen therapy (HFNC) versus conventional oxygen therapy (COT) on the reintubation rate, rate of escalation of respiratory support and clinical outcomes in postextubation adult surgical patients.

Design

Systematic review and meta-analysis of published literature.

Data sources

PubMed, Embase, the Cochrane Library, Web of Science, China National Knowledge Index and Wan fang databases were searched up to August 2018.

Eligibility criteria

Studies in postoperative adult surgical patients (≥18 years), receiving HFNC or COT applied immediately after extubation that reported reintubation, escalation of respiratory support, postoperative pulmonary complications (PPCs) and mortality were eligible for inclusion.

Data extraction and synthesis

The following data were extracted from the included studies: first author’s name, year of publication, study population, country of origin, study design, number of patients, patients’ baseline characteristics and outcomes. Associations were evaluated using risk ratio (RR) and 95% CIs.

Results

This meta-analysis included 10 studies (1327 patients). HFNC significantly reduced the reintubation rate (RR 0.38, 95% CI 0.23 to 0.61, p<0.0001) and rate of escalation of respiratory support (RR 0.43, 95% CI 0.26 to 0.73, p=0.002) in postextubation surgical patients compared with COT. There were no differences in the incidence of PPCs (RR 0.87, 95% CI 0.70 to 1.08, p=0.21) or mortality (RR 0.45, 95% CI 0.16 to 1.29, p=0.14).

Conclusion

HFNC is associated with a significantly lower reintubation rate and rate of escalation of respiratory support compared with COT in postextubation adult surgical patients, but there is no difference in the incidence of PPCs or mortality. More well-designed, large randomised controlled trials are needed to determine the subpopulation of patients who are most likely to benefit from HFNC therapy.
Comparative efficacy and complication rates after local treatment for cervical intraepithelial neoplasia and stage 1a1 cervical cancer: protocol for a systematic review and network meta-analysis from the CIRCLE Group
Authors: Athanasiou Antonios , Veroniki Areti Angeliki , Efthimiou Orestis , Kalliala Ilkka , Naci Huseyin , Bowden Sarah , Paraskevaidi Maria , Martin-Hirsch Pierre , Bennett Philip , Paraskevaidis Evangelos , Salanti Georgia , Kyrgiou Maria
Published: August 2019

Introduction

Local treatments for cervical intraepithelial neoplasia (CIN) and microinvasive disease remove or ablate a cone-shaped part of the uterine cervix containing the abnormal cells. A trend toward less radical techniques has raised concerns that this may adversely impact the rates of precancerous and cancerous recurrence. However, there has been no strong evidence to support such claims. We hereby describe a protocol of a systematic review and network meta-analysis that will update the evidence and compare all relevant treatments in terms of efficacy and complications.

Methods and analysis

Literature searches in electronic databases (CENTRAL, MEDLINE, EMBASE) or trial registries will identify published and unpublished randomised controlled trials (RCTs) and cohort studies comparing the efficacy and complications among different excisional and ablative techniques. The excisional techniques include cold knife, laser or Fischer cone, large loop or needle excision of the transformation zone and the ablative radical point diathermy, cryotherapy, cold coagulation or laser ablation. The primary outcome will be residual/recurrent disease defined as abnormal histology or cytology of any grade, while secondary outcomes will include treatment failure rates defined as high-grade histology or cytology, histologically confirmed CIN1+ or histologically confirmed CIN2+, human papillomavirus positivity rates, involved margins rates, bleeding and cervical stenosis rates. We will assess the risk of bias in RCTs and observational studies using tools developed by the Cochrane Collaboration. Two authors will independently assess study eligibility, abstract the data and assess the risk of bias. Random-effects meta-analyses and network meta-analyses will be conducted using the OR for dichotomous outcomes and the mean difference for continuous outcomes. The quality of the evidence for the primary outcome will be assessed using the CINeMA (Confidence In Network Meta-Analysis) tool.

Ethics and dissemination

Ethical approval is not required. We will disseminate findings to clinicians, policy-makers, patients and the public.

PROSPERO registration number

CRD42018115508.
Symptom screening in paediatrics tool for screening multiple symptoms in Brazilian patients with cancer: a cross-sectional validation study
Authors: Cadamuro Sandra de Andrade , Franco Julia Onishi , Paiva Carlos Eduardo , de Oliveira Cleyton Zanardo , Paiva Bianca Sakamoto Ribeiro
Published: August 2019

Objective

The objective of this study was to translate, culturally adapt and validate the Symptom Screening in Paediatrics Tool (SSPedi) into the Brazilian Portuguese language to be used by paediatric oncology patients in Brazil.

Design

A descriptive, cross-sectional study that follows an established methodology for translation and cultural adaptation, developed in two phases: phase I, linguistic translation and cultural adaptation of the SSPedi scale and phase II, psychometric properties evaluation.

Setting

Children’s Hospital for Cancer Treatment in Latin America.

Participants

Paediatric patients between 7 and 18 years of age and proxies of patients between 2 and 6 years of age, diagnosed with cancer and undergoing chemotherapy treatment. Patients and proxies with significant neuropsychiatric disorders and/or visual impairment that prevented the ability to read were excluded.

Primary outcome measures

Construct validation of SSPedi using convergent validity and contrasted groups. Reliability was evaluated using Cronbach’s alpha test and assessing the retest using the intraclass correlation coefficient (ICC).

Results

The psychometric properties of the symptom screening tool were evaluated using 157 participants, of which 116 were patients and 41 were proxies. Convergent validity and hypothesised correlations (Spearman’s r>0.4) were confirmed for both self- and proxy-reported versions of the assessment tool. No significant differences found between the two contrasting groups. Assessment of SSPedi resulted in an internal consistency of reliability of α=0.77 (95% CI 0.70 to 0.82) for the self and α=0.81 (95% CI 0.71 to 0.88) for the proxy and overall reproducibility ICC values of (95% CI), 0.54 (0.15 to 0.77) and 0.77 (0.64 to 0.86).

Conclusion

SSPedi was found to be culturally and linguistically adaptable and considered valid and reliable for use by paediatric oncology patients in Brazil. The new translated and adapted version was named SSPedi-BR.
Transition program for adolescents with congenital heart disease in transition to adulthood: protocol for a mixed-method process evaluation study (the STEPSTONES project)
Authors: Saarijärvi Markus , Wallin Lars , Moons Philip , Gyllensten Hanna , Bratt Ewa-Lena
Published: August 2019

Introduction

Today, the majority of young persons living with chronic conditions in high-income countries survive into adulthood and will need life-long medical follow-up. Therefore, transition programmes have been developed to facilitate transfer to adult care, and to support self-management and independence during adulthood. The Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS (STEPSTONES) project aims to evaluate the effectiveness of a person-centred transition programme for empowering adolescents with congenital heart disease in transition to adulthood. To understand how the transition programme causes change and how outcomes are created, process evaluation is imperative to assess implementation, context and mechanisms of impact. This protocol aims to describe the process evaluation of the STEPSTONES transition programme.

Methods and design

Medical Research Council guidance for process evaluation of complex interventions will be the guiding framework for this mixed-method study. The combination of qualitative and quantitative data will capture different aspects of programme delivery. The sample will consist of participants in the STEPSTONES randomised controlled trial (RCT), persons implementing the programme and healthcare professionals. Quantitative data will consist of protocols and routine monitoring documents from the RCT, data collected from patient registries and sociodemographic data to assess the implementation of the intervention. This data will be analysed with quantitative content analysis, along with descriptive and inferential statistics. Qualitative data will consist of participatory observations, logbooks and interviews with persons implementing the programme, participants and healthcare professionals. Analyses will be performed using qualitative content analysis to investigate mechanism of impact, context and delivery. Quantitative and qualitative data will be integrated in the final stage by using a triangulation protocol according to mixed-method guidelines.

Ethics and dissemination

The study is approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be presented in open access, peer-reviewed journals and at international scientific conferences.
Outcome and comparator choice in molar incisor hypomineralisation (MIH) intervention studies: a systematic review and social network analysis
Authors: Elhennawy Karim , Krois Joachim , Jost-Brinkmann Paul-Georg , Schwendicke Falk
Published: August 2019

Objectives

Outcome and comparator choice strongly determine the validity and implementation of clinical trial results. We aimed to assess outcome and comparator choice in intervention studies on molar incisor hypomineralisation (MIH) using systematic review and social network analysis (SNA).

Design and data sources

Medline, Embase, Cochrane Central, Google Scholar, opengrey.eu as well as DRKS.de and Clinicaltrials.gov were searched for MIH intervention studies. The search covered the period from 1980 to 2019.

Eligibility criteria

Clinical single-arm/multiarm, controlled/uncontrolled studies reporting on the management of MIH were included. Reported outcomes and comparators were extracted and categorised. SNA was used to evaluate comparator choice and the resulting trial networks.

Data extraction

Of the 7979 identified records, 100 were evaluated in full text and 35 studies (17 randomised controlled trials, 14 prospective and 4 retrospective cohort studies) were included.

Results

In total, 2124 patients with a mean age of 11 years (min/max 6/70 years) were included. Outcomes fell in one of 11 different outcome categories: restoration success, aesthetic improvement, pain/hypersensitivity/discomfort, mineral gain, space management, anaesthesia effectiveness, preventive success, efficiency, quality of life, gingival and periodontal health and patient satisfaction. Comparators were mainly restorative interventions (17 studies), remineralisation (3), treatment of hypersensitivity (10), aesthetic interventions (5) and orthodontic interventions (3). Two highly clustered comparator networks emerged; many interventions were not robustly linked to these networks.

Conclusions

MIH intervention studies recorded both clinically centred and patient-centred outcomes. Core outcome set development should consider these and supplement them with outcomes on, for example, applicability. The high number of compared interventions tested in only few studies and our SNA results implicate that the current evidence may not be robust.
Users’ experiences of a pragmatic diabetes prevention intervention implemented in primary care: qualitative study
Authors: Aujla Navneet , Yates Thomas , Dallosso Helen , Kai Joe
Published: August 2019

Objectives

To explore service-user and provider experience of the acceptability and value of theLet’s Prevent Diabetesprogramme, a pragmatic 6-hour behavioural intervention using structured group education, introduced into primary care practice.

Design

Qualitative interview-based study with thematic analysis.

Setting

Primary care and community.

Participants

Purposeful sample of 32 participants, including 22 people at high risk of diabetes who either attended, defaulted from or declined the intervention; and 10 stakeholder professionals involved in implementation.

Results

Participants had low prior awareness of their elevated risk and were often surprised to be offered intervention. Attenders were commonly older, white, retired and motivated to promote their health; who found their session helpful, particularly for social interaction, raising dietary awareness, and convenience of community location. However attenders highlighted lack of depth, repetition within and length of session, difficulty meeting culturally diverse needs and no follow-up as negative features. Those who defaulted from, or who declined the intervention were notably apprehensive, uncertain or unconvinced about whether they were at risk of diabetes; sought more specific information about the intervention, and were deterred by its group nature and day-long duration, with competing work or family commitments. Local providers recognised inadequate communication of diabetes risk to patients. They highlighted significant challenges for implementation, including resource constraints, and facilitation at individual general practice or locality level.

Conclusions

This pragmatic diabetes prevention intervention was acceptable in practice, particularly for older, white, retired and health-motivated people. However, pre-intervention information and communication of diabetes risk should be improved to increase engagement and reduce potential fear or uncertainty, with closer integration of services, and more appropriate care pathways, to facilitate uptake and follow-up. Further development of this, or other interventions, is needed to enable wider, and more socially diverse, engagement of people at risk. Balancing a locality and individual practice approach, and how this is resourced are considerations for long-term sustainability.
Tablet-based sensorimotor home-training system for amnestic mild cognitive impairments in the elderly: design of a randomised clinical trial
Authors: Bekrater-Bodmann Robin , Löffler Annette , Silvoni Stefano , Frölich Lutz , Hausner Lucrezia , Desch Simon , Kleinböhl Dieter , Flor Herta
Published: August 2019

Introduction

Dementia (particularly Alzheimer’s disease, AD) is a major cause of impaired cognitive functions in the elderly. Amnestic mild cognitive impairment (aMCI) is a prodromal stage of AD, if substantiated by Alzheimer biomarkers. A neuroscientific model of pathological ageing emphasises the loss of brain plasticity, sensorimotor capacities and subsequent cognitive decline. A mechanistic treatment targeting dysfunctional plastic changes associated with ageing should be efficacious in delaying AD. In this trial, we aim to evaluate the effectiveness of a newly developed sensorimotor training, delivered at home, combined with personalised reinforcement, on the progression of aMCI-related cognitive impairments.

Methods and analysis

In a randomised trial, we will compare two aMCI groups (30 subjects each), randomly allocated to a sensorimotor or a cognitive control training. Both trainings consist of an adaptive algorithm, and will last 3 months each. We hypothesise that both trainings will have positive effects on cognitive function with the sensorimotor training being superior compared with the control training based on its improvement in basic perceptual skills underlying memory encoding and retrieval. The primary outcome is episodic memory function, improved hippocampal function during memory tasks will be a secondary outcome. As further exploratory outcomes, we expect improved segregation in sensory and motor maps, better sensory discrimination only in the sensorimotor training and reduced transition to dementia (examined after completion of this study). We expect the experimental training to be evaluated more positively by the users compared with the cognitive training, resulting in reduced rates of discontinuation.

Ethics and dissemination

The Ethics Committee of the Medical Faculty Mannheim, Heidelberg University, approved the study (2015–543N-MA), which adheres to the Declaration of Helsinki. The results will be published in a peer-reviewed journal. Access to raw data is available on request.

Trial registration number

DRKS00012748.
Factors associated with elevated consumption of alcohol in older adults—comparison between China and Norway: the CLHLS and the HUNT Study
Authors: Li Juan , Wu Bei , Tevik Kjerstin , Krokstad Steinar , Helvik AS
Published: August 2019

Objectives

The primary objective was to investigate the prevalence and factors associated with elevated alcohol consumption among older adults 65 years and above in China and Norway. The secondary objective was to compare the prevalence and factors in the two countries.

Design

A secondary data analysis was conducted using two large cross-sectional studies (Chinese Longitudinal Healthy Longevity Survey data in 2008–2009 and Nord-Trøndelag Health Study data in 2006–2008).

Participants

A total of 3223 (weighted) Chinese older adults and 6210 Norwegian older adults who responded drinking alcohol were included in the analysis.

Outcome measures

The dependent variable was elevated alcohol consumption, which was calculated as a ratio of those with elevated drinking among current drinkers. Multivariable logistic regression was used to test the dependent variable.

Results

The prevalence of elevated alcohol consumption among current drinkers for the Chinese and Norwegian samples were 78.3% (weighted) and 5.1%, respectively. Being male was related to a higher likelihood of elevated alcohol consumption in both Chinese and Norwegian samples (OR=2.729, 95% CI 2.124 to 3.506, OR=2.638, 95% CI 1.942 to 3.585). Being older, with higher levels of education and a living spouse or partner were less likely to have elevated drinking in the Chinese sample (OR=0.497, 95% CI 0.312 to 0.794, OR=0.411, 95% CI 0.260 to 0.649, OR=0.533, 95% CI 0.417 to 0.682, respectively). Among Norwegian older adults, a higher level of education was related to higher likelihood of elevated drinking (OR=1.503, 95% CI 1.092 to 2.069, OR=3.020, 95% CI 2.185 to 4.175). Living in rural areas and higher life satisfaction were related to lower likelihood of elevated drinking in the Norwegian sample (OR=0.739, 95% CI 0.554 to 0.984, OR=0.844, 95% CI 0.729 to 0.977, respectively).

Conclusions

The elevated alcohol consumption patterns were strikingly different between China and Norway in regards to prevalence and socioeconomic distribution. To develop and implement culturally appropriate public health policies regarding alcohol in the future, public health policy makers and professionals need to be aware of the cultural differences and consider the demographic, social and economic characteristics of their intended population.
High Life Study protocol: a cross-sectional investigation of the influence of apartment building design policy on resident health and well-being
Authors: Foster Sarah , Maitland Clover , Hooper Paula , Bolleter Julian , Duckworth-Smith Anthony , Giles-Corti Billie , Arundel Jonathan
Published: August 2019

Introduction

The rapid increase in apartment construction in Australia has raised concerns about the impacts of poorly designed and located buildings on resident health and well-being. While apartment design policies exist, their content varies across jurisdictions and evidence on their impact on health and well-being is lacking. This cross-sectional observational study (2017–2021) aims to generate empirical evidence to guide policy decisions on apartment development and help to create healthy, equitable higher-density communities. Objectives include to benchmark the implementation of health-promoting apartment design requirements and to identify associations between requirements and resident health and well-being outcomes.

Methods and analysis

Eligible buildings in three Australian cities with different apartment design guidelines will be stratified by area disadvantage and randomly selected (~n=99). Building architects, developers and local governments will be approached to provide endorsed development plans from which apartment and building design features will be extracted. Additional data collection includes a resident survey (~n=1000) to assess environmental stressors and health and well-being impacts and outcomes, and geographic information systems measures of the neighbourhood. The study has 85% power to detect a difference of 0.5 SD in the primary outcome of mental well-being (Warwick-Edinburgh Mental Well-being Scale) at a 5% level of significance. Analyses will compare policy compliance and health-promoting design features between cities and area disadvantage groups. Regression models will test whether higher policy compliance (overall and by design theme) is associated with better health and well-being, and the relative contribution of the neighbourhood context.

Ethics and dissemination

Human Research Ethics Committees of RMIT University (CHEAN B 21146-10/17) and the University of Western Australia (RA/4/1/8735) approved the study protocol. In addition to academic publications, the collaboration will develop specific health-promoting indicators to embed into the monitoring of apartment design policy implementation and impact, and co-design research dissemination materials to facilitate uptake by decision makers.