bluuebunny/crossref_metadata_2025 huggingface dataset:
Pelvic and central nervous system tuberculosis complicated by a paradoxical response manifesting as a spinal tuberculoma: a case report
Authors: Zandvakili Arya , Kobayashi Takaaki , Kaewpoowat Quanhathai , Parsons Meredith G. , Ford Bradley , Barker Jason H. , Johnson Melinda
Published: September 2022

Background

The post-partum period is a risk factor for tuberculosis (TB), possibly including the period after miscarriage as illustrated here. This case demonstrates how non-specific symptoms can hide widely disseminated TB.

Case presentation

A healthy 26-year-old female with a history of recent miscarriage presented to the emergency department with non-specific symptoms of headache, abdominal pain, and sub-acute fevers. She had immigrated to the United States from the Marshall Islands 9 years prior. Two months prior to presentation she had a miscarriage at 18 weeks of pregnancy. On admission, transvaginal ultrasound revealed retained products of conception and abdominal computed tomography revealed findings consistent with tubo-ovarian abscesses and peritonitis. The obstetrics and gynecology service performed dilation and curettage (D&C) to remove retained products of conception. Acid-fast bacilli cultures from cerebrospinal fluid as well as specimens from D&C and intra-abdominal abscesses subsequently all grew TB. She was diagnosed with TB meningitis, peritonitis, endometritis, and tubo-ovarian abscesses. Her treatment course was complicated by a paradoxical response resulting in a spinal tuberculoma causing lower extremity weakness. The tuberculoma was treated with surgical decompression as well as continuation of treatment with anti-tubercular chemotherapy and steroids.

Conclusion

Disseminated and extrapulmonary TB can present with non-specific symptoms. Recognition of risk factors for TB is critical for prompt diagnostic evaluation and treatment of this deadly disease. A paradoxical reaction needs to be taken into consideration when any new neurological symptoms occur during TB treatment.
Quality of life of cutaneous leishmaniasis suspected patients in the Ecuadorian Pacific and Amazon regions: a cross sectional study
Authors: Bezemer Jacob Machiel , Hinojosa Manuel Calvopiña , Zabala Andrea Estefania Corral , Pérez Fernando Ortega , Román Veronica Cristina Vargas , Schallig Henk Dirk Frederik Herman , de Vries Henry John Christiaan
Published: September 2022

Background

Yearly, up to 1 million patients worldwide suffer from cutaneous leishmaniasis (CL). In Ecuador, CL affects an estimated 5000 patients annually. CL leads to reduced Health Related Quality of Life (HRQL) as a result of stigma in the Asian and Mediterranean contexts, but research is lacking for Ecuador. The objective of this study was to explore the influence of CL suspected lesions on the quality of life of patients in the Pacific and Amazon regions.

Methods

Patients for this study were included in the Amazonian Napo, Pastaza, and Morona Santiago provinces and the Pacific region of the Pichincha province. Participating centers offered free of charge CL treatment. All patients suspected of CL and referred for a cutaneous smear slide microscopy examination were eligible. This study applied the Skindex-29 questionnaire, a generic tool to measure HRQL in patients with skin diseases. All statistical analysis was done with SPSS Statistics version 28.

Results

The skindex-29 questionnaire was completed adequately by 279 patients who were included in this study. All patient groups from the Amazon scored significantly (P < 0.01) higher (indicating worse HRQL) on all the dimensions of the Skindex-29 questionnaire than Mestizo patients from the Pacific region. The percentage of patients with health seeking delay of less than a month was significantly (P < 0.01) lower in the Amazon region (38%) than in the Pacific (66%).

Conclusions

The present study revealed that the influence of suspected CL lesions on the HRQL of patients in the Ecuadorian Amazon and Pacific depends on the geographic region more than on patient characteristics such as gender, age, number of lesions, lesion type, location of lesions, health seeking delay, or posterior confirmation of the Leishmania parasite. The health seeking delay in the Amazon might result from a lack of health infrastructure or related stigma. Together, the impaired HRQL and prolonged health seeking delay in the Amazon lead to prolonged suffering and a worse health outcome. Determinants of health seeking delay should be clarified in future studies and CL case finding must be improved. Moreover, HRQL analysis in other CL endemic regions could improve local health management.
Progressive sensory ataxia and breast implant rupture, an uncommon presentation of a debated concept: a case report
Authors: Van Assche Sofie , Parmentier Heleen , Varkas Gaelle , Peene Isabelle , Herdewyn Sarah
Published: September 2022

Background

Autoimmune Syndrome Induced by Adjuvants (ASIA) is a concept introduced by Shoenfeld to group various disease entities believed to be triggered by an infection, silicone exposure or other external stimuli. A causal link between the use of silicone and the development of autoimmune diseases and lymphoma has been suggested in the past. Sjögren’s Syndrome (SS) is one of the autoimmune diseases that has been postulated as an example of ASIA syndrome. Although typically characterized by sicca, SS can manifest as a ganglionopathy as the primary presenting symptom. To our knowledge, this is the first case report in which a ganglionopathy unveiled an underlying SS in the context of a possible ASIA syndrome.

Case presentation

We describe a case of a 44-year-old woman who developed rapidly progressive sensory loss in the 4 limbs with a walking impairment due to the severe sensory ataxia. After extensive work-up, she was diagnosed with a ganglionopathy as the first symptom of SS, and the concurrent diagnosis of a bilateral breast implant leakage with severe inflammation due to silicone bleeding. After surgical removal of the prostheses and initiation of immunosuppressive therapy, stabilization of symptoms was achieved.

Conclusion

This case report brings to attention the possibility of a sensory ganglionopathy as first and isolated symptom of SS. The occurrence of SS in the setting of ASIA stir up the discussion about the safety of silicone breast implants.
Protocol of the TREASURE study: Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease – a randomized, open-label, multicenter phase II trial
Authors: Bozorgmehr Farastuk , Christopoulos Petros , Chung Inn , Cvetkovic Jelena , Feißt Manuel , Krisam Johannes , Schneider Marc A. , Heußel Claus Peter , Kreuter Michael , Müller Daniel W. , Thomas Michael , Rieken Stefan
Published: September 2022

Background

Recently, the combination of the programmed death-ligand 1 (PD-L1) inhibitor atezolizumab with first-line chemotherapy has demonstrated to improve outcome for patients with advanced small cell lung cancer (SCLC), leading to approval of this regimen. At the same time, accumulating (pre-)clinical data suggest synergisms of radiotherapy and immunotherapy via the radiation-mediated induction of anti-tumor immunogenicity. Combining the recent findings, the TREASURE trial aims at further enhancing response to upfront chemo-immunotherapy by the addition of thoracic radiotherapy (TRT).

Methods/design

The TREASURE trial is a randomized, multicenter, phase II clinical trial (ClinicalTrials.gov identifier, NCT04462276). One hundred four patients suffering from extensive disease (ED) SCLC, with any response to the standard of care induction chemo-immunotherapy will be randomized to receive atezolizumab maintenance therapy with or without TRT. The primary endpoint of this study is overall survival (OS). Secondary endpoints include further measures of efficacy, safety, and the collection of biomarker samples. A safety interim analysis will take place after n = 23 patients receiving TRT have been observed for three months after the end of TRT.

Discussion

This trial will investigate whether treatment efficacy can be improved by adding TRT to atezolizumab maintenance therapy in ED SCLC patients with any response after chemo-immunotherapy. Safety and feasibility of such a regimen will be evaluated, and biomaterials for a translational research project will be collected. Together, the results of this trial will deepen our comprehension of how checkpoint inhibition and radiotherapy interact and contribute to the evolving landscape of SCLC therapy.

Trial registration

Clinicaltrials.gov identifier: NCT04462276 (Date of initial registration: 8th July 2020), https://clinicaltrials.gov/ct2/show/NCT04462276

Eudra-CT Number: 2019-003916-29 (Date of initial registration: 30th March 2020), https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-003916-29/DE
Real-world analysis of different intracranial radiation therapies in non-small cell lung cancer patients with 1–4 brain metastases
Authors: Chen Zhengting , Zhou Lingli , Zhao Min , Cao Ke , Li Yanqing , Liu Xiaoling , Hou Yu , Li Lan , Wang Li , Chang Li , Yang Mei , Li Wenhui , Xia Yaoxiong
Published: September 2022

Purpose

Stereotactic radiosurgery (SRS) has become a standard approach for the treatment of patients with few metastatic brain lesions. However, the optimal treatment approach for the use radiotherapy in the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases (BMs) remain unclear. This study aimed to compare the survival outcomes and intracranial local control in NSCLC patients with 1–4 BMs who are treated with SRS using linear accelerators (LINAC-SRS), whole-brain radiotherapy (WBRT), or WBRT plus radiotherapy boost (WBRT + RTB).

Materials and methods

We retrospectively analyzed 156 NSCLC patients with 1–4 BMs who received LINAC-SRS, WBRT, and WBRT + RTB. The median overall survival (OS), intracranial progression-free survival (iPFS), and distant brain failure-free survival (DBF-FS) and related prognostic factors were analyzed.

Results

The median follow-up period was 31.6 months. The median OS times in the LINAC-SRS, WBRT, and WBRT + RTB groups were not reached, 33.3 months and 27.9 months, respectively. The difference in survival rate was non-significant (P = 0.909). The 2-year iPFS and DBF-FS rates in the LINAC-SRS, WBRT and WBRT + RTB groups were 51.6% and 37.5%; 42.0% and 50.4%; and 51.1% and 56.1%, respectively. There was no significant difference in 2-year iPFS or DBF-FS among the three groups (P = 0.572 for iPFS, P = 0.628 for DBF-FS). Multivariate analysis showed that the independent adverse prognostic factors for OS, iPFS, and DBF-FS were neurological symptoms, recursive partitioning analysis (RPA) class, and targeted therapy.

Conclusion

LINAC-SRS did not result in significantly superior survival times or intracranial local control compared to WBRT or WBRT + RTB in the treatment of NSCLC patients with 1–4 BMs.
Effect of thoracic radiotherapy dose on the prognosis of advanced lung adenocarcinoma harboring EGFR mutations
Authors: Qin Hongyue , Ke Jiaojiao , Dong Shuai , Li Huani , Zhu Kunli , Fu Shuai , Shao Qian , Li Zhenxiang
Published: September 2022

Background

The aim of this study was to investigate the effects of different thoracic radiotherapy doses on OS and incidence of radiation pneumonia which may provide some basis for optimizing the comprehensive treatment scheme of these patients with advanced EGFR mutant lung adenocarcinoma.

Methods

Data from 111 patients with EGFR-mutant lung adenocarcinoma who received thoracic radiotherapy were included in this retrospective study. Overall survival (OS) was the primary endpoints of the study. Kaplan–Meier method was used for the comparison of OS. The Cox proportional-hazard model was used for the multivariate and univariate analyses to determine the prognostic factors related to the disease.

Results

The mOS rates of the patients, who received radiotherapy dose scheme of less than 50 Gy, 50–60 Gy (including 50 Gy), and 60 Gy or more were 29.1 months, 34.4 months, and 51.0 months, respectively (log-rank P = 0.011). Although trend suggested a higher levels of pneumonia cases with increasing radiation doses, these lack statistical significance (χ2 = 1.331; P = 0.514). The multivariate analysis showed that the thoracic radiotherapy dose schemes were independently associated with the improved OS of patients (adjusted hazard ratio [HR], 0.606; 95% CI, 0.382 to 0.961; P = 0.033).

Conclusions

For the patients with advanced EGFR-mutant lung adenocarcinoma, the radical thoracic radiotherapy dose scheme (≥ 60 Gy) could significantly prolong the OS of patients during the whole course management.
Unilateral buphthalmos, corneal staphyloma and corneal fistula caused by pathogenic variant in the PITX3 gene: a case report
Authors: Zhou Lin , Xu Zhike , Wu Qianying , Wei Xin
Published: September 2022

Introduction

PITX3 has been reported to be associated with congenital cataracts, anterior segment mesenchymal dysgenesis, Peters’ anomaly, and microphthalmia. In this case, an infant with unilateral buphthalmos, corneal staphyloma and corneal fistula carrying a variant in PITX3 was reported.

Case description

We describe a 4-month-old female infant who was referred to our Eye Clinic because of gradual enlargement of the eyeball in the right eye and whitish opacity in both eyes. Buphthalmos with long axial length (22.04 mm), macrocornea with diffuse corneal oedema and opacity (14.50 mm*14.50 mm) and high intraocular pressure (23.78 mmHg) were detected in the right eye. Microphthalmia with short axial length (16.23 mm), microcornea with diffuse corneal oedema and opacity (7.50 mm*6.50 mm) were detected in the left eye. A 360° trabeculotomy was performed for the right eye. However, corneal staphyloma and corneal fistula in the right eye were detected 6 months after the surgery. A variant in exon 4 of PITX3 (c.640_656dup (p. Gly220Profs*95)) was identified in the proband but was not detected in her healthy parents.

Conclusion

A novel phenotype characterized by unilateral buphthalmos, corneal staphyloma and corneal fistula in an infant were reported to be associated with PITX3 in our study. Our study expands the scope of the clinical heterogeneity of PITX3 variants. It also improves our understanding and increases the attention given to patients with PITX3 variants.
Uveitis and nail psoriasis in a patient without articular involvement: a case report
Authors: Pineda-Sierra Juan Sebastián , Peña-Pulgar Luisa Fernanda , Cifuentes-González Carlos , Rojas-Carabali William , de-la-Torre Alejandra
Published: September 2022

Background

This study aimed to report a case of bilateral anterior non-granulomatous chronic non-infectious uveitis associated with isolated nail psoriasis without articular involvement.

Case presentation

A 55-year-old man with a history of open-angle glaucoma was referred to our uveitis and ocular immunology center with intraocular inflammation concordant with chronic non-infectious bilateral anterior non-granulomatous uveitis. At presentation, he had moderate inflammation in the anterior chamber bilaterally and lesions characteristic of nail psoriasis. Nail psoriasis was later confirmed by nail ultrasonography performed by a radiologist who specialized in psoriasis. Appropriate clinical and paraclinical assessments were conducted, ruling out all other possible causes of uveitis. The patient required dual systemic immunomodulatory therapy with methotrexate and adalimumab, topical anti-inflammatory drugs (steroidal and non-steroidal), and anti-glaucoma therapy to achieve satisfactory inflammatory and ocular pressure control.

Discussion and conclusions

This is the first report of non-infectious uveitis associated with nail compromise in a patient without other manifestations of psoriasis. Despite reports on the relationship between psoriatic disease and uveitis, there is insufficient information on clinical phenotypes associated with uveitis that could lead to later diagnosis and treatment of associated intraocular inflammation. Clinicians should be aware of all subtypes of psoriasis that increases a risk of developing uveitis in these patients.
Modified argon laser therapy for benign tumor of the eyelid
Authors: Han Jisang , Lee Shin-Hyo , Choi Chul Young , Khoramnia Ramin , Kim Jaemin , Shin Hyun Jin
Published: September 2022

Background

To report about the therapy of benign eyelid tumors with a modified argon laser technique as an alternative to surgery.

Methods

Nineteen benign tumors of the eyelid were included in this study. After staining the surface of the tumor with a violet marker, low-energy argon laser photoablation was performed. A mean number of 312 spots (spot size ranging from 150 to 500 μm) with a power of 200 to 400 mW, and a duration between 0.1 and 0.2 s were applied.

Results

The eyelid tumors were located mainly in the lower eyelid (58%). Dermal nevi and papilloma were the most frequently treated lesions. Over a mean follow-up period of 10.5 months (range 6–18 months), all eyelid tumors were successfully treated by a single session of laser therapy. All patients were satisfied with the laser therapy and the cosmetic result. No postoperative complications were observed. No relapses occurred during follow-up.

Conclusions

Our modified method of argon laser therapy utilizes the staining of the surface of the eyelid tumor to increase the amount of thermal laser energy absorbed by the target. This novel technique is simple and effective for treating benign eyelid tumors.
Time to first optimal glycemic control and its predictors among type 1 diabetic children in Bahir Dar city public referral hospitals, North West Ethiopia: a retrospective follow up study
Authors: Meseret Fentahun , Belachew Amare , Tesfa Getasew , Mengesha Teshale , Embiale Tsegasew , Alemu Ayichew , Dagne Melsew
Published: September 2022

Background

Recognizing the level of glycemic control of a client is an important measure/tool to prevent acquiring complications and risk of death from diabetes. However, the other most important variable, which is the time that the patient stayed in that poor glycemic level before reaching optimal glycemic control, has not been studied so far. Therefore, this study aim to estimate time to first optimal glycemic control and identify predictors among type 1 diabetic children in Bahir Dar city public referral hospitals, Northwest, Ethiopia, 2021.

Methods

A Retrospective cohort study was conducted at Bahir Dar city public referral hospitals among a randomly selected sample of 385 patients with type 1 diabetes who were on follow up from January 1, 2016 to February30, 2021.Data were collected by using a data abstraction tool and then entered into Epi-data version 4.6 and exported into STATA 14.0 statistical software. Descriptive statistics, Kaplan Meier plots and median survival times, Log-rank test and Cox-proportional hazard regression were used for reporting the findings of this study. After performing Cox-proportional hazard regression, model goodness-of-fit and assumptions were checked. Finally, the association between independent variables and time to first optimal glycemic control in months was assessed using the multivariable Cox Proportional Hazard model and variables with a p-value < 0.05 were considered as statistically significant.

Results

Median survival time to first optimal glycemic control among type 1 diabetic clients was 8 months (95%CI: 6.9–8.9). The first optimal glycemic achievement rate was 8.2 (95%CI: 7.2–9.2) per 100 person/month observation. Factors that affect time to first optimal glycemic control were age > 10–14 years (AHR = 0.32;95%CI = 0.19–0.55), increased weight (AHR = 0.96;95%CI = 0.94–0.99), having primary care giver (AHR = 2.09;95%CI = 1.39–3.13), insulin dose (AHR = 1.05;95%CI = 1.03–1.08), duration of diabetes ≥4 years (AHR = 0.64;95%CI = 0.44–0.94), adherence to diabetic care (AHR = 9.72;95%CI = 6.09–15.51), carbohydrate counting (AHR = 2.43;95%CI = 1.12–5.26), and comorbidity (AHR = 0.72;95%CI = 0.53–0.98).

Conclusion

The median survival time to first optimal glycemic control in this study was long. Age, weight, primary care giver, insulin dose, duration of diabetes, adherence, and carbohydrate counting, including history of comorbidity were determinant factors. Giving attention for overweight and comorbid illness prevention, increasing either the dose or frequency of insulin during initial treatment; counseling parent (for both the mother and father) about adherence to diabetic care focusing on insulin drugs and how to audit their children’s diet as prescription helps to reduce the length of glycemic control.
Recovery Colleges Characterisation and Testing in England (RECOLLECT): rationale and protocol
Authors: Hayes Daniel , Henderson Claire , Bakolis Ioannis , Lawrence Vanessa , Elliott Rachel A. , Ronaldson Amy , Richards Gabrielle , Repper Julie , Bates Peter , Brewin John , Meddings Sara , Winship Gary , Bishop Simon , Emsley Richard , Elton Daniel , McNaughton Rebecca , Whitley Rob , Smelson David , Stepanian Katy , McPhilbin Merly , Dunnett Danielle , Hunter-Brown Holly , Yeo Caroline , Jebara Tesnime , Slade Mike
Published: September 2022

Background

Recovery Colleges are a relatively recent initiative within mental health services. The first opened in 2009 in London and since then numbers have grown. They are based on principles of personal recovery in mental health, co-production between people with lived experience of mental health problems and professionals, and adult learning. Student eligibility criteria vary, but all serve people who use mental health services, with empirical evidence of benefit. Previously we developed a Recovery College fidelity measure and a preliminary change model identifying the mechanisms of action and outcomes for this group, which we refer to as service user students. The Recovery Colleges Characterisation and Testing (RECOLLECT) study is a five-year (2020–2025) programme of research in England. The aim of RECOLLECT is to determine Recovery Colleges’ effectiveness and cost-effectiveness, and identify organisational influences on fidelity and improvements in mental health outcomes. 

Methods

RECOLLECT comprises i) a national survey of Recovery Colleges, ii) a prospective cohort study to establish the relationship between fidelity, mechanisms of action and psychosocial outcomes, iii) a prospective cohort study to investigate effectiveness and cost-effectiveness, iv) a retrospective cohort study to determine the relationship between Recovery College use and outcomes and mental health service use, and v) organisational case studies to establish the contextual and organisational factors influencing fidelity and outcomes. The programme has been developed with input from individuals who have lived experience of mental health problems. A Lived Experience Advisory Panel will provide input into all stages of the research.

Discussion

RECOLLECT will provide the first rigorous evidence on the effectiveness and cost effectiveness of Recovery Colleges in England, to inform their prioritising, commissioning, and running. The validated RECOLLECT multilevel change model will confirm the active components of Recovery Colleges. The fidelity measure and evidence about the fidelity-outcome relationship will provide an empirically-based approach to develop Recovery Colleges, to maximise benefits for students. Findings will be disseminated through the study website (researchintorecovery.com/recollect) and via national and international Recovery College networks to maximise impact, and will shape policy on how Recovery Colleges can help those with mental health problems lead empowered, meaningful and fulfilling lives.
Drivers of respiratory health care demand in Acre state, Brazilian Amazon: a cross-sectional study
Authors: Morello Thiago , Lima Aldo Santos , da Silva Rubicleis Gomes
Published: September 2022

Background

The scarce knowledge about the drivers of demand for respiratory health care in the Brazilian Amazon, where the gap of human and physical health care resources is wide, is expanded with two surveys conducted in the west of the region, in Acre state. Potential drivers, informed by a review of twelve recent papers, were classified into seven categories capturing the individual, household, community and macroeconomic dimensions.

Methods

Quantitative field surveys were conducted in 2017 and 2019 based on coupled conglomerate-quota randomization sampling. Adults responded about their own health or their children’s health. The probability of seeking physician care for the latest episode of respiratory illness or dry cough was analysed with multiple nonlinear regressions, having as covariates the potential predictors informed by the literature.

Results

The propensity to seek health care and to purchase medication was larger for children. Influenza-like illness (Despite the exact diagnostic stated by respondents being “influenza”, a virus detection test (such as the PCR test) is not commonly applied, as informed by the Acre state public health service. In consistency, the term “influenza-like illness” is used.) was the most frequently diagnosed disease, followed by pneumonia, suggesting that a health care-seeking rate below 40% may perpetuate health impairment and local contagion. Illnesses’ severity, including the pain experienced, was the main predictor, revealing that subjective perception was more influential than objective individual and household characteristics.

Conclusions

The results suggest that subjective underestimation of respiratory illnesses’ consequences for oneself and for local society could prevent health care from being sought. This is in line with some previous studies but departs from those emphasizing the role of objective factors. Social consequences, of, for instance, a macroeconomic nature, need to be highlighted based on studies detecting long-run relationships among health care demand, health and economic performance at the national level. Depending on the intensity of the trade-off between the costs imposed on the health system by increased demand and on the economy by the reduced productivity of the ill, policy could be adopted to change subjective perceptions of illnesses with nudges and educational and informational interventions.
Co-design of an oral health intervention (HABIT) delivered by health visitors for parents of children aged 9–12 months
Authors: Owen Jenny , Gray-Burrows Kara A. , Eskytė Ieva , Wray Faye , Bhatti Amrit , Zoltie Timothy , Staples Annalea , Giles Erin , Lintin Edwina , West Robert , Pavitt Sue , McEachan Rosemary R. C. , Marshman Zoe , Day Peter F.
Published: September 2022

Background

Dental caries (tooth decay) in children is a national public health problem with impacts on the child, their family and wider society. Toothbrushing should commence from the eruption of the first primary tooth. Health visitors are a key provider of advice for parents in infancy and are ideally placed to support families to adopt optimal oral health habits. HABIT is a co-designed complex behaviour change intervention to support health visitors’ oral health conversations with parents during the 9–12-month universal developmental home visit.

Methods

A seven stage co-design process was undertaken: (1) Preparatory meetings with healthcare professionals and collation of examples of good practice, (2) Co-design workshops with parents and health visitors, (3) Resource development and expert/peer review, (4) Development of an intervention protocol for health visitors, (5) Early-phase testing of the resources to explore acceptability, feasibility, impact and mechanism of action, (6) Engagement with wider stakeholders and refinement of the HABIT intervention for wider use, (7) Verification, Review and Reflection of Resources.

Results

Following preparatory meetings with stakeholders, interviews and co-design workshops with parents and health visitors, topic areas and messages were developed covering six key themes. The topic areas provided a structure for the oral health conversation and supportive resources in paper-based and digital formats. A five-step protocol was developed with health visitors to guide the oral health conversation during the 9–12 month visit. Following training of health visitors, an early-phase feasibility study was undertaken with preliminary results presented at a dissemination event where feedback for further refinement of the resources and training was gathered. The findings, feedback and verification have led to further refinements to optimise quality, accessibility, fidelity and behaviour change theory.

Conclusion

The co-design methods ensured the oral health conversation and supporting resources used during the 9–12 month visit incorporated the opinions of families and Health Visitors as well as other key stakeholders throughout the development process. This paper provides key learning and a framework that can be applied to other healthcare settings. The structured pragmatic approach ensured that the intervention was evidence-based, acceptable and feasible for the required context.

Trial registration

ISRCTN55332414, Registration Date 11/11/2021.
Socioeconomic position and adverse childhood experiences as risk factors for health-related behaviour change and employment adversity during the COVID-19 pandemic: insights from a prospective cohort study in the UK
Authors: Smith Madeleine L. , Herbert Annie , Hughes Amanda , Northstone Kate , Howe Laura D.
Published: September 2022

Background

Non-pharmaceutical interventions to reduce the spread of COVID-19 may have disproportionately affected already disadvantaged populations.

Methods

We analysed data from 2710 young adult participants of the Avon Longitudinal Study of Parents and Children. We assessed the associations of socioeconomic position (SEP) and Adverse Childhood Experiences (ACEs, e.g. abuse, neglect, measures of family dysfunction) with changes to health-related behaviours (meals, snacks, exercise, sleep, alcohol and smoking/vaping), and to financial and employment status during the first UK lockdown between March–June 2020.

Results

Experiencing 4+ ACEs was associated with reporting decreased sleep quantity during lockdown (OR 1.53, 95% CI: 1.07–2.18) and increased smoking and/or vaping (OR 1.85, 95% CI: 0.99–3.43); no other associations were seen between ACEs or SEP and health-related behaviour changes. Adverse financial and employment changes were more likely for people with low SEP and for people who had experienced multiple ACEs; e.g. a history of 4+ ACEs was associated with being furloughed or on other leave during lockdown (OR 1.92, 95% CI: 1.35–2.74).

Conclusions

In this sample of young adults, there was little evidence that lockdown worsened inequalities in health-related behaviours. However, adverse financial and employment consequences of lockdown were more likely to be experienced by people who have already experienced socioeconomic deprivation or childhood adversity, thereby widening social inequalities and demonstrating the need for support into adulthood for those with a history of ACEs.
Effects of intergenerational contact on social capital in community-dwelling adults aged 25–84 years: a non-randomized community-based intervention
Authors: Nemoto Yuta , Nonaka Kumiko , Kuraoka Masataka , Murayama Sachiko , Tanaka Motoki , Matsunaga Hiroko , Murayama Yoh , Murayama Hiroshi , Kobayashi Erika , Inaba Yoji , Watanabe Shuichiro , Maruo Kazushi , Fujiwara Yoshinori
Published: September 2022

Background

Accumulating social capital in urban areas is essential to improve community health. Previous studies suggested that intergenerational contact may be effective for enhancing social capital. However, no study has examined the effect of intergenerational contact on social capital through a population-based evaluation. This study aimed to investigate the effects of a community-based intervention to increase the frequency of intergenerational contact on social capital among adults aged 25–84 years.

Methods

This study used a non-randomized controlled trial design to conduct a community-based intervention (from March 2016 to March 2019). The study area was Tama ward, Kawasaki city, Kanagawa, Japan. The area comprises five districts; one district was assigned as the intervention group and the other four districts as the control group. We provided the intervention to residents in the intervention group. The intervention comprised three phases: Phase 1 was the preparation term (organizing the project committee); Phase 2 was the implementation term (trained volunteer staff members, conducted the intergenerational greeting campaign, and held intergenerational contact events); and Phase 3 was the transition term (surrendering the lead role of the project to the city hall field workers). In the control group, field workers provided public health services as usual. We conducted mail surveys in September 2016 and November 2018 to assess the effects of the intervention on social capital during Phase 2. Eligible participants were randomly selected from community-dwelling adults aged 25–84 years according to age (10,620 control group individuals and 4479 intervention group individuals). We evaluated social trust, norm of reciprocity, and social support as outcome variables.

Results

In total, 2518 participants completed both surveys and were analyzed (control group: 1727; intervention group: 791). We found that social trust (coefficient = 0.065; 95% confidence interval [CI]: 0.006, 0.125) and norm of reciprocity (coefficient = 0.084; 95% CI: 0.020, 0.149) positively changed in the intervention group compared with the control group.

Conclusions

This community-based intervention may contribute to sustaining and improving social capital among community-dwelling adults.

Trial registration: UMIN000046769 (UMIN-CTR); first registered on January 28, 2022 (retrospectively registered).
Characteristics of hospital admissions for pulmonary alveolar proteinosis: analysis of the nationwide inpatient sample (2012–2014)
Authors: Kim Chongiin , Garcia-Tome Rodrigo , Hurtado Carolina , Ding Li , Wang Tisha , Chang Ching-Fei
Published: September 2022

Background

Pulmonary alveolar proteinosis (PAP) is a rare clinical syndrome involving the accumulation of lipid-rich proteinaceous material in the alveoli. There is a paucity of published studies on this condition. To better characterize the demographics, complication rates, mortality, and healthcare costs of patients hospitalized for PAP in the United States, a secondary analysis on the Hospital Cost and Utilization Project’s Nationwide Inpatient Sample (NIS) was performed on patients admitted from 2012 to 2014 with a diagnosis of pulmonary alveolar proteinosis.

Methods

Using the NIS database, a secondary analysis was performed on 500 admissions with the diagnosis “pulmonary alveolar proteinosis.” The clinical variables and outcome measures extracted were: patient demographics, hospital costs, length of stay, frequency of admissions, and inpatient mortality rate.

Results

Among a weighted estimate of 500 hospital admissions from 2012 to 2014, the number of PAP admissions averaged 4.7 per million. The population was predominantly male (55%) with a mean age of 41.45 (CI 38.3–44.5) from all socioeconomic levels. Inpatient mortality was calculated to be 5%, which may result from the fact that the majority of admitted patients had few or no comorbid conditions (CCI 0.72). The most common procedure performed during admission was a bronchoalveolar lavage. Mean length of stay was 6.2 days (CI 3.9–8.5) and average cost of admission was $29,932.20 (CI 13,739–46,124). Of note, 50% of these admissions were considered “elective.”

Conclusions

Demographics of patients with PAP who have been hospitalized in the United States are similar to previously reported demographics from prior patient cohorts, specifically a male predominance and a mean age in the 40 s. The inpatient mortality rate of 5% we found is consistent with prior studies demonstrating good disease-specific survival rates. Notably, the cost per admission and overall annual cost associated with PAP hospitalization was calculated to be $29932.20 and $5 million respectively. This reflects the high economic cost associated with hospitalization of PAP patients, and provokes thought about ways to make treatment more cost-effective.
A pragmatic randomised controlled trial of tailored pulmonary rehabilitation in participants with difficult-to-control asthma and elevated body mass index
Authors: Ricketts Helen Clare , Sharma Varun , Steffensen Femke , Goodfellow Anna , Mackay Elaine , MacDonald Gordon , Buchan Duncan S. , Chaudhuri Rekha , Cowan Douglas C.
Published: September 2022

Background

Difficult-to-control asthma associated with elevated body mass index (BMI) is challenging with limited treatment options. The effects of pulmonary rehabilitation (PR) in this population are uncertain.

Methods

This is a randomised controlled trial of an eight-week asthma-tailored PR programme versus usual care (UC) in participants with difficult-to-control asthma and BMI ≥ 25 kg/m2. PR comprised two hours of education and supervised exercise per week, with encouragement for two individual exercise sessions. Primary outcome was difference in change in Asthma Quality of Life Questionnaire (AQLQ) in PR versus UC groups between visits. Secondary outcomes included difference in change in Asthma Control Questionnaire-6 (ACQ6), and a responder analysis comparing proportion reaching minimum clinically important difference for AQLQ and ACQ6.

Results

95 participants were randomised 1:1 to PR or UC. Median age was 54 years, 60% were female and median BMI was 33.8 kg/m2. Mean  (SD) AQLQ was 3.9 (+/-1.2) and median (IQR) ACQ6 2.8(1.8–3.6). 77 participants attended a second visit and had results analysed. Median (IQR) change in AQLQ was not significantly different: 0.3 (− 0.2 to 0.6) in PR and − 0.1 (− 0.5 to 0.4) in UC, p = 0.139. Mean change in ACQ6 was significantly different: − 0.4 (95% CI − 0.6 to − 0.2) in PR and 0 (− 0.3 to + 0.3) in UC, p = 0.015, but below minimum clinically important difference. In ACQ6 responder analysis, minimum clinically important difference was reached by 18 PR participants (54.5%) versus 10 UC (22.7%), p = 0.009. Dropout rate was 31% between visits in PR group, and time to completion was significantly prolonged in PR group at 94 (70–107) days versus 63 (56–73) in UC, p < 0.001.

Conclusions

PR improved asthma control and reduced perceived breathlessness in participants with difficult-to-control asthma and elevated BMI. However, this format appears to be suboptimal for this population with high drop-out rates and prolonged time to completion.

Trial registration Clinicaltrials.gov. ID NCT03630432. Retrospectively registered, submitted May 26th 2017, posted August 14th 2018.
Systematic endoscopic staging of mediastinum to determine impact on radiotherapy for locally advanced lung cancer (SEISMIC): protocol for a prospective single arm multicentre interventional study
Authors: Steinfort Daniel P. , Siva Shankar , Rangamuwa Kanishka , Lee Percy , Fielding David , Nguyen Phan , Jennings Barton R. , Yo Shaun , Hardcastle Nick , Kothari Gargi , Crombag Laurence , Annema Jouke , Yasufuku Kazuhiro , Ost David E. , Irving Louis B.
Published: September 2022

Background

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is established as the preferred method of mediastinal lymph node (LN) staging in non-small cell lung cancer (NSCLC). Selective (targeted) LN sampling is most commonly performed however studies in early stage NSCLC and locally advanced NSCLC confirm systematic EBUS-TBNA evaluation improves accuracy of mediastinal staging. This study aims to establish the rate of detection of positron emission tomography (PET)-occult LN metastases following systematic LN staging by EBUS-TBNA, and to determine the utility of systematic mediastinal staging for accurate delineation of radiation treatment fields in patients with locally advanced NSCLC.

Methods

Consecutive patients undergoing EBUS-TBNA for diagnosis/staging of locally advanced NSCLC will be enrolled in this international multi-centre single arm study. Systematic mediastinal LN evaluation will be performed, with all LN exceeding 6 mm to be sampled by TBNA. Where feasible, endoscopic ultrasound staging (EUS-B) may also be performed. Results of minimally invasive staging will be compared to FDG-PET. The primary end-point is proportion of patients in whom systematic LN staging identified PET-occult NSCLC metastases. Secondary outcome measures include (i) rate of nodal upstaging, (ii) false positive rate of PET for mediastinal LN assessment, (iii) analysis of clinicoradiologic risk factors for presence of PET-occult LN metastases, (iv) impact of systematic LN staging in patients with discrepant findings on PET and EBUS-TBNA on target coverage and dose to organs at risk (OAR) in patients undergoing radiotherapy.

Discussion

With specificity of PET of 90%, guidelines recommend tissue confirmation of positive mediastinal LN to ensure potentially early stage patients are not erroneously denied potentially curative resection. However, while confirmation of pathologic LN is routinely sought, the exact extent of mediastinal LN involvement in NSCLC in patient with Stage III NSCLC is rarely established. Studies examining systematic LN staging in early stage NSCLC report a significant discordance between PET and EBUS-TBNA. In patients with locally advanced disease this has significant implications for radiation field planning, with risk of geographic miss in the event of PET-occult mediastinal LN metastases. The SEISMIC study will examine both diagnostic outcomes following systematic LN staging with EBUS-TBNA, and impact on radiation treatment planning.

Trial registration

ACTRN12617000333314, ANZCTR, Registered on 3 March 2017.
New Moms Wellness Study: the randomized controlled trial study protocol for an intervention study to increase fruit and vegetable intake and lower breast cancer risk through weekly counseling and supplemental fruit and vegetable box delivery in breastfeeding women
Authors: Sturgeon Susan R. , Sibeko Lindiwe , Balasubramanian Raji , Arcaro Kathleen F.
Published: September 2022

Background

Laboratory studies indicate that chemicals in fruits and vegetables have anti-carcinogenic and anti-inflammatory activities that can lower breast cancer risk. However, epidemiologic studies of the association between fruit and vegetable intake and breast cancer risk have produced mixed results. Measurement error, confounding, and an emphasis on diet in later adulthood may contribute to weak associations. This paper describes a randomized controlled diet intervention trial in breastfeeding women to examine the effect of high fruit and vegetable intake on breast cancer risk factors, including weight, DNA methylation and inflammatory markers.

Methods

Eligible breastfeeding women who reside within a 35-mile radius of Amherst, MA are enrolled at five to six weeks postpartum and randomly assigned to a Fruit and Vegetable Intervention Arm (target n = 200) or to a USDA MyPlate Control Arm (target n = 200). The Fruit and Vegetable Intervention group receives weekly telephone or video-based counseling to encourage intake of at least eight to ten daily servings of fruits and vegetables and a weekly delivery of a supplemental box of fruits and vegetables for 20 weeks, and less intensive counseling for up to one year. Breastmilk and infant fecal specimens are collected at baseline, 10 and 20 weeks. Anthropometric measurements are obtained at these timepoints and at the 1-year follow-up. The primary outcomes are change in DNA methylation in breast epithelial cells and change in inflammatory markers in breastmilk from randomization to 20 weeks; and change in weight, waist circumference, and fruit and vegetable intake for the period from randomization to 20 weeks and 1 year.

Discussion

This 1-year randomized diet intervention trial in breastfeeding women will assess whether intake of at least eight to ten daily servings of fruits and vegetables per day improves biomarkers of breast cancer risk directly in the breast (i.e., DNA methylation and inflammatory markers) and helps women maintain a healthy weight.

Trial registration: ClinicalTrials.gov Identifier: NCT04374747. Registered May 5, 2020. https://www.clinicaltrials.gov/ct2/show/NCT04374747.
The PIER framework for healthcare simulation integration in undergraduate physiotherapy education
Authors: van der Merwe Anke , Barnes Roline Yvette , Labuschagne Mathys Jacobus
Published: September 2022

Background

The need for healthcare curricula renewal to facilitate a continuum in education from classrooms to diverse healthcare settings is undeniable. Simulation has been recognized as an educational strategy to address healthcare education challenges, with limited reporting on the integration of simulation-based learning experiences in physiotherapy education. The study aimed to describe the finalisation of a framework for integration of healthcare simulation in an undergraduate physiotherapy program.

Methods

A qualitative descriptive research design was utilized. Five South African experts in the fields of healthcare simulation and/or physiotherapy education contributed to the finalization of the framework during a consensus meeting. Content analysis was employed and credibility was ensured through double coding.

Results

Structural coding yielded five themes- Planning, Implementation, Program Evaluation, Program Revision and Framework. The five themes consisted of fifteen categories, two sub-categories and 44 codes. The planning theme was most robust with seven categories. The Planning, Implementation, Evaluation, Revision (PIER) framework was developed and finalized by expert participants. following the consensus meeting.

Conclusion

Needs analyses when planning and incorporating simulation is essential. Collaboration through resource and knowledge sharing is vital in developing a responsive curriculum integrating simulation. Furthermore, facilitator and student preparation are paramount in ensuring active engagement in simulated-based learning experiences. The interconnectedness of all framework elements and integration phases, as well as the implied importance of competent facilitators and prepared students is crucial and highlights careful consideration to be given to these aspects. The PIER framework is generic in nature and represents the continuous process of simulation integration for any healthcare program.
Parental waivers to enable adolescent participation in certain forms of health research: lessons from a South African case study
Authors: Strode Ann , Essack Zaynab
Published: September 2022

Background

The South African legal framework requires mandatory parental/legal guardian consent for all research with children. Ethics guidelines provide some reprieve by allowing RECs to grant waivers of parental or guardianship consent in certain defined circumstances. In the first instance, consent may be provided by a proxy when parents or guardians are unavailable, for example with orphaned children. In the second instance, guidelines permit adolescent self-consent when the nature of the study justifies this approach, for example, research on sensitive issues like sexual behaviour or substance use.

Discussion

South African guidelines set several conditions that must be met for waivers to be granted. These norms overlap with those in international guidelines. However, the ethical norms, especially related to self-consent are sometimes vague. This article critically evaluates the consent norms in the national ethics guidelines and makes recommendations for reform to ethics guidelines in a way that recognises the value of child participation in research, their evolving decision-making capacity and their best interests.

Conclusion

Recommendations are made to harmonise ethics guidelines and law in a way that promotes child participation in research, to ensure additional protections for adolescents when self-consent is allowed, and to withdraw procedural requirements for the community endorsement of self-consent strategies.