bluuebunny/crossref_metadata_2025 huggingface dataset:
Adjunct role of potassium-rich vegetarian diet and a novel potassium food supplement to improve pain in chronic rheumatoid arthritis on supervised standard care: a randomised controlled study
Authors: Kianifard Toktam , Saluja Manjit , Sarmukaddam Sanjeev , Venugopalan Anuradha , Chopra Arvind
Published: January 2024

Introduction

An earlier food survey showed dietary potassium deficiency in rheumatoid arthritis (RA).

Objective

To evaluate an adjunct role of oral potassium to reduce joint pain in RA.

Methods

172 consenting eligible symptomatic patients (median duration 6.5 years) on standard care were randomised into an assessor blind, parallel efficacy, controlled, prospective, multiarm single-centre study (80% power, drug trial design) of 16 weeks duration—arm A (potassium-rich vegetarian diet), arm B (arm A plus novel potassium food supplement) and arm C (control, regular diet). Standard efficacy (American College of Rheumatology recommendation) and safety and diet intake (3-day recall) were assessed at monthly intervals (protocol). Standard soft-ware package (SPSS V.20) was used for statistical analysis; analysis of variance), Mann-Whitney statistic and χ2test.; significant p<0.05, two sided). Study arms were found matched at baseline. Background RA medication remained stable. Preset target for increased potassium intake (India standards) were mostly achieved and participants remained normokalemic.

Results

155 patients (90.1%) completed the study and several showed improvement (maximum improved measures in arm B). Potassium intervention was safe and well tolerated. Adverse events were mild; none caused patient withdrawal. On comparison, the mean change in pain visual analogue scale (−2.23, 95% CI −2.99 to −1.48) at week 16 (primary efficacy) from baseline was significantly superior in arm B (per protocol analysis). A high daily potassium intake (5–7.5 g, arm B) was significantly associated with low pain (study completion); OR 2.5 (univariate analysis), likelihood ratio 2.9 (logistic regression). Compliance (intervention), diet record and analysis, RA medication and absence of placebo were potential confounders.

Conclusion

High oral potassium intake, based on a suitable vegetarian diet and food supplement, reduced joint pain and improved RA. It was a safe adjunct to standard care, Further validation studies are required.

Trial registration

CTRI/2022/03/040726; Clinical Trial Registry of India.
Prevalence and short-term change in symptoms of anxiety and depression following bariatric surgery: a prospective cohort study
Authors:   On behalf of The By-Band-Sleeve Collaborating Group
Published: January 2024

Objectives

Bariatric surgery is an effective treatment for severe obesity that leads to significant physical health improvements. Few studies have prospectively described the short-term impact of surgery on mental health using standardised case-finding measures for anxiety or depressive disorders. This study describes the prevalence and short-term course of these conditions following surgery.

Design

Prospective observational cohort study.

Setting

12 National Health Service centres in England.

Participants

Participants studied took part in the By-Band-Sleeve study, a multicentre randomised controlled trial evaluating the surgical management of severe obesity. We included participants who had undergone surgery (gastric bypass, gastric band or sleeve gastrectomy) within 6 months of randomisation.

Primary and secondary outcome measures

Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and 12 months post-randomisation. Sociodemographic variables collected at prerandomisation included body mass index, age, sex, ethnicity, marital status, tobacco use, employment status and income band.

Results

In our sample of 758 participants, 94.5% (n 716) and 93.9% (n 712) had completed baseline anxiety (HADS-A) and depression (HADS-D) subscales. At pre-randomisation 46.1% (n 330/716, 95% CI 42.4% to 49.7%) met clinical case criteria for anxiety and 48.2% (n 343/712, 95% CI 44.5% to 51.8%) for depression. Among participants returning completed 12 months post-randomisation questionnaires (HADS-A n 503/716, HADS-D n 498/712), there was a significant reduction in the proportion of clinical cases with anxiety (−9.5%, 95% CI −14.3% to -4.8% p<0.001) and depression (−22.3%, 95% CI −27.0% to −17.6% p<0.001).

Conclusions

Almost half of people undergoing bariatric surgery had underlying anxiety or depressive symptoms. In the short term, these symptoms appear to substantially improve. Future work must identify whether these effects are sustained beyond the first post-randomisation year.

Trial registration number

NCT02841527andISRCTN00786323.
Scope, range and effectiveness of interventions to address social norms to prevent and delay child marriage and empower adolescent girls: a systematic review
Authors: Greene Margaret E. , Edmeades Jeffrey , Siddiqi Manahil
Published: January 2024

Objectives

Harmful gender and social norms prescribe divergent opportunities for girls and boys and drive child marriage. This systematic review examines the scope, range and effectiveness of interventions to change social norms and delay child marriage.

Design

We systematically assess the contributions made by interventions that work to shift norms to prevent child marriage or to limit its harmful consequences. Our analysis classifies each study’s quality in evaluation and implementation design regarding shifting norms.

Data sources

We conducted a search of electronic databases (PubMed, PsycINFO, Embase, CINAHL Plus, Popline, Web of Science and Cochrane Library) and grey literature (targeted hand-searches of 15 key organisations and Google Scholar).

Eligibility criteria

Included interventions sought to change norms related to child marriage, were evaluated in experimental or quasi-experimental evaluations, collected data on age at marriage and norms/attitudes, and were published in English from January 2000 to September 2021.

Data extraction and synthesis

We used a standardised form to extract data from all eligible studies, and double-screened to validate coding and reporting. We classified the studies by low, medium and high quality for evaluation and risk of bias, and separately by the extent to which they addressed social norms.

Results

Our assessment of the 12 eligible studies identified revealed little evidence of a systematic relationship between social norms related to marriage and changes in child marriage behaviours. We found stronger evidence of programme effect on child marriage outcomes than on social norms, though only a minority of studies found an effect for either. Studies that appeared effective in changing child marriage norms varied greatly in scale and extent of programming, and few attempted to identify the appropriate reference groups for measuring social norms.

Conclusion

The studies evaluated by our review provide only weak evidence on the impact of interventions on norms, and on the link between shifts in norms and marriage behaviour.
Effect of extracorporeal shock wave combined with Kinesio taping on upper limb function during individuals with biceps brachii tendinopathy：protocol for a double-blind, randomised controlled trial
Authors: Liu Kun , Yin Lulu , Zhang Ye , Huang Lihua , Liu Gongliang , Zhu Ran , Fang Ping , Ma Yanhong , Ma Zheng
Published: January 2024

Introduction

Long head of biceps brachii tendinopathy (LHBT) is characterised by persistent pain and disability of shoulder joint, impairing patients’ quality of life. Extracorporeal shock wave therapy (ESWT) is a non-invasive treatment, which promotes tissue regeneration and repair. However, ESWT has a side effect that often causes short-term pain and swelling in the treatment area. It is known that the effects of Kinesio taping (KT) on relieving swelling and pain. Due to insufficient clinical evidence from current limited studies, this randomised controlled study aims to explore the effects of ESWT combined with KT on upper limb function during individuals with LHBT.

Methods and analysis

A 2×2 factorial design, double-blind, randomised controlled trial will be conducted. A total of 144 participants will be randomly allocated into one of four groups (KT+ESWT, KT+sham ESWT, sham KT+ESWT or sham KT+sham ESWT) to participate in a 4-week treatment programme. Measurements will be taken at pretreatment (baseline), immediately after treatment and 6 weeks after treatment. The primary endpoint will be the Constant-Murley score (CMS), the secondary endpoints will include the pain Numerical Rating Scale, range of motion, pressure pain threshold and soft tissue hardness of biceps, speed test and global rating of change. Repeated measures analysis of variance will be used to compare differences among the effects of different interventions.

Ethics and dissemination

Ethics approval was obtained from the Ethics Committee of the Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. In addition to international conference reports, findings will be disseminated through international publications in peer-reviewed journals.

Trial registration number

ChiCTR2100051324.
Distribution of intranasal naloxone to potential opioid overdose bystanders in Sweden: effects on overdose mortality in a full region-wide study
Authors: Håkansson Anders , Alanko Blomé Marianne , Isendahl Pernilla , Landgren Maria , Malmqvist Ulf , Troberg Katja
Published: January 2024

Objectives

Distribution of take-home naloxone is suggested to reduce opioid-related fatalities, but few studies have examined the effects on overdose deaths in the general population of an entire community. This study aimed to assess the effects on overdose deaths of a large-scale take-home naloxone programme starting in June 2018, using an observational design with a historic control period.

Design

From the national causes of death register, deaths diagnosed as X42 or Y12 (International Classification of Diseases, 10th revision, ICD-10) were registered as overdoses. Numbers of overdoses were calculated per 100 000 inhabitants in the general population, and controlled for data including only individuals with a prior substance use disorder in national patient registers, to focus on effects within the primary target population of the programme. The full intervention period (2019–2021) was compared with a historic control period (2013–2017).

Setting

Skåne county, Sweden.

Participants

General population.

Interventions

Large-scale take-home naloxone distribution to individuals at risk of overdose.

Primary and secondary outcome measures

Decrease in overdose deaths per 100 000 inhabitants, in total and within the population with substance use disorder diagnosis.

Results

Annual average number of overdose deaths decreased significantly from 3.9 to 2.8 per 100 000 inhabitants from the control period to the intervention period (a significant decrease in men, from 6.7 to 4.3, but not in women, from 1.2 to 1.3). Significant changes remained when examining only prior substance use disorder patients, and decreases in overdose deaths could not be attributed to a change in treatment needs for opioid use disorders in healthcare and social services.

Conclusions

The present study, involving 3 years of take-home naloxone distribution, demonstrated a decreased overdose mortality in the population, however, only in men. The findings call for further implementation of naloxone programmes, and for further studies of potential effects and barriers in women.

Trial registration number

NCT03570099.
What works, how and in which contexts when supporting parents to implement intensive speech and language therapy at home for children with speech sound disorder? A protocol for a realist review
Authors: Leafe Naomi , Pagnamenta Emma , Taggart Laurence , Donnelly Mark , Hassiotis Angela , Titterington Jill
Published: January 2024

Introduction

Speech and language therapists (SLTs) worldwide report challenges with providing recommended, evidence-based intervention intensity for children with speech sound disorder (SSD). Challenges such as service constraints and/or family contexts impact on access to optimal therapy intensity. Existing research indicates that empowering and training parents to deliver intervention at home, alongside SLT support, offers one possible solution to increasing the intensity of intervention children with SSD receive. Digital health could increase accessibility to intensive home practice and help sustain engagement with therapy activities. Further exploration is needed around what makes parent-implemented interventions for children with SSD effective, for who and in which situations. This paper outlines the protocol for a realist review which aims to explore the active ingredients and contextual factors of effective digital parent-led interventions.

Methods and analysis

A realist review will explore the research question, following six stages. The scope of the review will be determined, and initial programme theories will be developed about what works in digital parent-implemented interventions for SSD, for whom, how, why and in what circumstances. Relevant secondary data, identified through a formal search strategy, will be selected, appraised, analysed and synthesised using realist principles to test and further refine the initial programme theories. This process will develop refined underpinning explanatory theories which capture the interaction between contexts, mechanisms and outcomes of the intervention. An expert steering group will provide insight to inform explanatory theories, searches, and dissemination.

Ethics and dissemination

Ethical approval is not required for this review. The refined programme theories from the review will inform the next stages of a wider study. A subsequent realist evaluation will test and further refine theories with key stakeholders. Following this, the underpinning programme theory will be used to coproduce a digital tool, to support parents to deliver home intervention alongside SLT support.
Burden of drug-resistant tuberculosis among contacts of index cases: a protocol for a systematic review
Authors: Akalu Temesgen Yihunie , Clements Archie C A , Gebreyohannes Eyob Alemayehu , Wolde Haileab Fekadu , Shiferaw Fasil Wagnaw , Alene Kefyalew Addis
Published: January 2024

Introduction

People having close contact with drug-resistant tuberculosis (DR-TB) patients are at increased risk of contracting and developing the disease. However, no comprehensive review has been undertaken to estimate the burden of DR-TB among contacts of DR-TB patients. Therefore, the current systematic review will quantify the prevalence and incidence of DR-TB among contacts of DR-TB patients.

Method and analysis

Systematic searches will be conducted in Medline, Embase, Web of Science, Scopus, Cochrane Central Register of Controlled trials (CENTRAL) and Cumulative Index to Nursing and Allied Health Literature (CINHAL) databases. The search will be conducted without restrictions on time, language and geography. A random-effects meta-analysis will be conducted for effect estimates. The pooled prevalence and incidence of DR-TB will be compared between people with and without contact with DR-TB patients. The presence of heterogeneity between studies will be assessed by Higgins I2statistics. Subgroup analysis will be conducted to determine the source of heterogeneity. The risk of bias will be assessed using a visual inspection of the funnel plot and Egger’s regression test statistics. Trim and fill analysis will be done in the presence of publication bias. A sensitivity analysis will be conducted by trimming low-quality studies. The systematic review will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines.

Ethics and dissemination

Ethical approval will not be required for this study as it will be a systematic review and meta-analysis based on previously published evidence. The findings of the systematic review will be presented at scientific conferences and published in scientific journals.

Protocol registration

The protocol is published in PROSPERO with registration number CRD42023390339.
Comparing the efficacy and safety of three surgical approaches for total hysterectomy (TSATH): protocol for a multicentre, single-blind, parallel-group, randomised controlled trial
Authors: Zhang Wenxi , Deng Li , Yang Fan , Liu Jianhong , Chen Sijing , You Xiaolin , Gou Jiani , Zi Dan , Li Yonghong , Qi Xiaoxue , Wang Yanzhou , Zheng Ying
Published: January 2024

Introduction

Hysterectomy is the most common surgical procedure in the field of gynaecology. The traditional multiport laparoscopy, transumbilical laparoendoscopic single-site surgery (TU-LESS) and transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy approaches have been implemented to varying degrees in clinical practice. At present, although their feasibility has been proven, there are no large randomised controlled studies on postoperative rehabilitation. This study aims to evaluate postoperative recovery and assess the safety and effectiveness of these three surgical approaches for total laparoscopic hysterectomy.

Method and analysis

This is a multicentre, randomised, single-blind, three-arm, parallel-group, interventional clinical trial. Recruitment will be carried out in five tertiary hospitals in China. Patients diagnosed with benign uterine disease or precancerous lesions will be assigned to the vNOTES group, TU-LESS group and conventional laparoscopy group at a 1:1:1 ratio. The achievement rate of comprehensive indices of enhanced recovery after surgery (ERAS) within 24 hours postoperatively will be considered the primary outcome (the comprehensive indicators of ERAS include fluid intake, passing flatus, urination after catheter removal, ambulation and a Visual Analogue Scale score ≤3.) This study will use a non-inferiority test, with a power (1−ß) of 80% and a margin of −0.15, at a one-sided α of 0.0125. The sample size will be 480 patients (including an assumed 15% dropout rate), calculated according to the primary outcome.

Ethics and dissemination

This study was approved on 25 April 2022 by the Medical Ethics Committee of West China Second University Hospital (2022(057)), Sichuan University, Chengdu, China. All participants will be required to provide informed consent before their participation in the study. The results of the trial will be submitted for publication in a peer-reviewed journal and presented at international conferences.

Protocol version

V.3.0, 31 August 2023.

Trial registration number

ChiCTR2200057405.
Does use of GP and specialist services vary across areas and according to individual socioeconomic position? A multilevel analysis using linked data in Australia
Authors: Butler Danielle C , Larkins Sarah , Jorm Louisa , Korda Rosemary J
Published: January 2024

Objective

Timely access to primary care and supporting specialist care relative to need is essential for health equity. However, use of services can vary according to an individual’s socioeconomic circumstances or where they live. This study aimed to quantify individual socioeconomic variation in general practitioner (GP) and specialist use in New South Wales (NSW), accounting for area-level variation in use.

Design

Outcomes were GP use and quality-of-care and specialist use. Multilevel logistic regression was used to estimate: (1) median ORs (MORs) to quantify small area variation in outcomes, which gives the median increased risk of moving to an area of higher risk of an outcome, and (2) ORs to quantify associations between outcomes and individual education level, our main exposure variable. Analyses were adjusted for individual sociodemographic and health characteristics and performed separately by remoteness categories.

Setting

Baseline data (2006–2009) from the 45 and Up Study, NSW, Australia, linked to Medicare Benefits Schedule and death data (to December 2012).

Participants

267 153 adults aged 45 years and older.

Results

GP (MOR=1.32–1.35) and specialist use (1.16–1.18) varied between areas, accounting for individual characteristics. For a given level of need and accounting for area variation, low education-level individuals were more likely to be frequent users of GP services (no school certificate vs university, OR=1.63–1.91, depending on remoteness category) and have continuity of care (OR=1.14–1.24), but were less likely to see a specialist (OR=0.85–0.95).

Conclusion

GP and specialist use varied across small areas in NSW, independent of individual characteristics. Use of GP care was equitable, but specialist care was not. Failure to address inequitable specialist use may undermine equity gains within the primary care system. Policies should also focus on local variation.
Magnitude and associated factors of cutaneous leishmaniasis among patients visiting Nefas Mewcha primary hospital, Northern Ethiopia, 2022: An institution-based Cross-sectional study
Authors: Bantie Berihun , Kassaw Gebrie , Demelash Agmasie Tigabu , Abate Moges Wubneh , Nigat Adane Birhanu , Amare Abraham Tsedalu , Birlie Tekalign Amera , Tasew Sheganew Fetene , Zeleke Shegaw , Kassie Ayalew , Tantigegn Sharie , Ambaw Lidiya Anteneh , Muhamed Ahmed Nuru , Melese Biruk Demissie
Published: January 2024

Background

Cutaneous leishmaniasis (CL) is the most common neglected tropical disease, causing stigmatised skin lesions. It is an important public health concern, with 95% of cases occurring in low-income and middle-income countries. Despite its long-recognized endemicity and psychosocial impacts, it is largely overlooked.

Objective

The main aim of this study is to investigate the magnitude and associated factors of CL in north-central Ethiopia.

Design

An institution-based cross-sectional study was conducted.

Setting

The study was conducted in Nefas Mewcha Primary Hospital (NMPH), north-central Ethiopia.

Participants

The study was conducted among 332 individuals visiting NMPH from June to July 2022.

Primary and secondary outcomes

The primary outcome was to estimate the burden of CL among patients visiting NMPH, and the secondary outcome was to identify factors associated with the presence or absence of CL. The association between predictor variables and CL was assessed using a binary logistic regression model. Statistical significance was declared at a p _value of <0.05.

Result

Out of the 332 study participants, 63 patients sought medical care with skin lesions, and 61 (18.37%, 95% CI: 14.5% to 22.9%) were patients with CL. Localized CL was the predominant type (86.9%). Male sex (adjusted OR (AOR): 4.51; 95% CI 1.94 to 10.45), older age (AOR 0.91, 95% CI: 0.87 to 0.94), secondary and tertiary educational status (AOR: 0.18, 95% CI: 0.05 to 0.6), poor knowledge of CL (AOR: 4.02, 95% CI: 1.81 to 9.76) and living with domestic animals (AOR: 5.29, 95% CI 3.24 to 7.5) were identified as predictors of CL.

Conclusion

In the study area, the magnitude of CL was found to be high. Being male and young, having low educational status, having poor knowledge and living with domestic animals increase the risk of acquiring CL. As a result, increasing the knowledge of the community through scaling up of health education programmes and reducing activities that increase individuals’ exposure to sandflies should be prioritised.
How do they cope? A national cross-sectional study of coping in hospital doctors in Ireland
Authors: Doherty Ailbhe , Prihodova Lucia , Walsh Gillian , Hayes Blánaid
Published: January 2024

Objectives

To measure coping strategies and associated psychological distress, burnout and work ability in hospital doctors in Ireland.

Design

National cross-sectional study of randomised sample of trainee and consultant hospital doctors.

Setting

Irish publicly funded hospitals and residential institutions.

Participants

1749 doctors returned surveys (55% response rate).

Outcome measures

Dependent variables were psychological distress (measured using 12-item General Health Questionnaire), burnout (Maslach Burnout Inventory) and work ability (single-item measure). Adaptive and maladaptive coping strategies (Brief Coping Orientation to Problems Experienced) were covariates.

Results

The coping mechanism most frequently reported by this cohort was the adaptive strategy of active planning. Increased mean hours worked (MHW) (OR 1.02; 95% CI 1.01 to 1.03), a low Work Ability Score (OR 3.23; 95% CI 2.47 to 4.23) and maladaptive coping strategies (OR 1.26; 95% CI 1.22 to 1.31) were significantly associated with psychological distress. Adaptive coping was associated with decreased psychological distress (OR 0.98; 95% CI 0.97 to 1.00). Increased MHW (OR 0.98; 95% CI 0.97 to 0.99), insufficient work ability (OR 0.62; 95% CI 0.48 to 0.80) and maladaptive coping (OR 0.87; 95% CI 0.85 to 0.89) were significantly associated with burnout. Increased MHW (OR 0.99; 95% CI 0.98 to 1.00) and maladaptive coping (OR 0.90, 95% CI 0.88 to 0.92) were significantly associated with insufficient work ability.

Conclusions

Adaptive coping is associated with decreased psychological distress but does not mitigate the effect of increased work hours, which are associated with burnout, distress and insufficient work ability, regardless of a doctor’s coping style. The burden of psychological distress on doctors cannot be mitigated meaningfully unless workplace factors are addressed.
Role of public health professionals in the climate and ecological crisis: a qualitative study
Authors: van Hove Maria , Davey Peter , Gopfert Anya
Published: January 2024

Background

The climate and ecological emergency is the single biggest health threat facing humanity, yet it is not clear to what extent the public health workforce have been involved in work on this topic. This research aimed to establish what public health consultants working in local authorities in England perceive their role to be, whether the climate crisis is seen as a core component of public health and to identify barriers to action.

Methods

Semi-structured interviews were undertaken with a purposive sample (n=11) of local authority public health consultants in England. Participants were recruited via public health organisations, social media or snowballing. Thematic content analysis was used to identify codes and themes.

Results

Public health professionals have started work on climate change but reported being unclear about their role and feeling isolated working on this topic. Barriers to action included shortage of financial resources, communication tools and capacity, limited sharing of best practice, lack of local expertise and conflict between the need for action on climate change and other urgent issues.

Conclusion

We highlight the need to urgently address existing barriers to enable this important part of the public health workforce to play their role in tackling the climate and ecological crisis.
The economic burden associated with unmet surgical needs in Liberia: a retrospective macroeconomic analysis based on a nationwide enumeration of surgical procedures
Authors: Adde Håvard A , Oghogho Mark D , van Duinen Alex J , Grimes Caris E , Hampaye Theophilus C , Quaife Matthew , Bolkan Håkon A
Published: January 2024

Objectives

The economic consequences of untreated surgical disease are potentially large. The aim of this study was to estimate the economic burden associated with unmet surgical needs in Liberia.

Design

A nationwide enumeration of surgical procedures and providers was conducted in Liberia in 2018. We estimated the number of disability-adjusted life years (DALYs) saved by operative activities and converted these into economic losses averted using gross national income per capita and value of a statistical life (VSL) approaches. The total, the met and the unmet needs for surgery were determined, and economic losses caused by unmet surgical needs were estimated. Finally, we valued the economic losses avoided by various surgical provider groups.

Results

A total of 55 890 DALYs were averted by surgical activities in 2018; these activities prevented an economic loss of between US$35 and US$141 million. About half of these values were generated by the non-specialist physician workforce. Furthermore, a non-specialist physician working a full-time position for 1 year prevented an economic loss of US$717 069 using the VSL approach, while a specialist resident and a certified specialist saved US$726 606 and US$698 877, respectively. The burden of unmet surgical need was associated with productivity losses of between US$388 million and US$1.6 billion; these losses equate to 11% and 46% of the annual gross domestic product for Liberia.

Conclusion

The economic burden of untreated surgical disease is large in Liberia. There is a need to strengthen the surgical system to reduce ongoing economic losses; a framework where specialist and non-specialist physicians collaborate may result in better economic return than a narrower focus on training specialists alone.
Electroacupuncture use for treatment of taxane-induced peripheral neuropathy in patients with breast cancer: protocol for a pilot, randomised, blinded, sham-controlled trial (EA for CIPN)
Authors: Choi Victoria , Park Susanna B , Lacey Judith , Kumar Sanjeev , Heller Gillian , Grimison Peter
Published: January 2024

Introduction

Chemotherapy-induced peripheral neuropathy (CIPN) is a common dose-limiting side effect of neurotoxic chemotherapy. Acute symptoms of CIPN during treatment can lead to dose reduction and cessation. Trials using electroacupuncture (EA) to treat established CIPN postchemotherapy have shown some efficacy. The current trial aims to assess the feasibility and preliminary efficacy of using EA to treat CIPN during chemotherapy.

Methods and analysis

The current study is a single-centre, 1:1 randomised, sham-controlled pilot study set in a tertiary cancer hospital in Sydney, Australia, and will recruit 40 adult patients with early breast cancer undergoing adjuvant or neoadjuvant paclitaxel chemotherapy. Patients who develop CIPN within the first 6 weeks of chemotherapy will receive either true EA or sham-EA once a week for 10 weeks. The coprimary endpoints are recruitment and adherence rate, successful blinding of patients and compliance with the follow-up period. Secondary endpoints are mean change of CIPN symptoms from randomisation to end of treatment, sustained change in CIPN symptoms at 8-week and 24-week follow-up postchemotherapy, proportion of subjects attaining completion of 12 weeks of chemotherapy without dose reduction or cessation, change in acupuncture expectancy response pretreatment, during treatment and posttreatment. The primary assessment tool for the secondary endpoints will be a validated patient-reported outcome measure (European Organisation for Research and Treatment of Cancer Quality of Life Chemotherapy-Induced Peripheral Neuropathy) captured weekly from randomisation to week 12 of chemotherapy.

Ethics and dissemination

The study protocol (2021/ETH12123) has been approved by the institutional Human Research Ethics Committee at St Vincent’s Hospital Sydney and Chris O’Brien Lifehouse. Informed consent will be obtained prior to starting study-related procedures. The results will be disseminated in peer-reviewed journals and at scientific conferences.

Trial registration number

ACTRN12622000081718.
Characterising respiratory infections among hospitalised children during the COVID-19 pandemic in southeastern China: a cross-sectional study of pathogens and clinical association
Authors: Huang Huanhuan , Wu Bin , Lin Wei
Published: January 2024

Objective

Children with acute respiratory tract infections (ARTIs) pose significantly burden on healthcare facilities due to high hospitalisation rates and mortality. However, limited epidemiological and clinical characteristics data on ARTIs in southeastern China during the COVID-19 pandemic exists.

Design

Cross-sectional.

Setting

Tertiary hospital associated with the First Affiliated Hospital, Fujian Medical University, China.

Participants

1007 hospitalised children diagnosed with ARTIs, aged 30 days to 15 years, were enrolled in this study from 1 January 2020 to 31 December 2021.

Outcome measure

The primary outcomes are the rate of pathogen infections in children with ARTIs. Secondary outcomes are the description of risk factors associated with ARTIs in children.

Results

Of the 1007 enrolled children, 28.2%, 42.2%, 21.8% and 7.7% were diagnosed with upper respiratory tract infection, bronchopneumonia, bronchitis and pneumonia, respectively.Mycoplasma pneumoniae(MP) was the most prevalent pathogen (31.9%), followed by influenza B virus (IFVB; 29.1%) and influenza A virus (IFVA; 19.1%). The study found that children under 1 year old (older than 30 days: ORIFVB=12.50; ORMP=8.53), children aged 1–3 years (ORMP=1.62), the winter season (ORIFVA=1.36), the time from symptoms onset to hospitalisation (ORMP=1.10) and increased precipitation (ORLP=1.01) were high-risk factors for ARTIs.

Conclusion

This investigation offers significant insights into the prevalence and distribution of common pathogens among children experiencing ARTIs in the context of the COVID-19 pandemic. The discernment of high-risk factors linked to these pathogens enhances our understanding of the epidemiological characteristics of ARTIs in children.
Study protocol for the validation of a new pictorial functional scale in patients with knee osteoarthritis: the functional activity scoring tool (FAST)
Authors: Tang Zhi Yin , Ng Khim Siong , Koh Yi Ling Eileen , Yeung Meredith T
Published: January 2024

Background

Patient-reported outcome measures (PROMs) are required for patient-centred care. There are limited PROMs with good psychometric properties, and limitations to any language-based scale are often constrained by the written words or numerals used. Therefore, we developed the Functional Activity Scoring Tool (FAST), a self-reporting pictorial scale. FAST measures the impact of knee osteoarthritis on essential activities of daily living (ADL) and the significant changes in the self-perceived functional status over time.

Objectives

This study aims to (1) develop FAST with adaptation from the Wong-Baker FACES pain rating scale, (2) validate FAST against the Patient-Specific Functional Scale (PSFS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) and (3) establish the reliability, validity and responsiveness of FAST in individuals with knee osteoarthritis.

Methods and analysis

The prospective study protocol investigates the validity, responsiveness and reliability of FAST. The PSFS and KOOS will be gold standard comparisons. Participant recruitment will occur at four public polyclinics that offer physiotherapy outpatient services in Singapore. Onsite physiotherapists familiar with the study eligibilities will refer potential participants to the investigators after the routine physiotherapy assessment. After providing written consent, eligible participants will complete outcome measurements with FAST, the PSFS and KOOS during baseline and follow-up assessments. The Global Rating of Change (GROC) scale will determine how the participant’s knee status was changed compared with the beginning of the physiotherapy intervention.

Ethics and dissemination

SingHealth Centralised Institutional Review Board approved the study (CIRB reference number: 2022/2602). The final results will be published via scientific publication. FAST will benefit the evaluation and management of those who suffer knee osteoarthritis regardless of English proficiency or language barriers.

Trial registration number

NCT05590663
Coeliac disease in the Trøndelag Health Study (HUNT), Norway, a population-based cohort of coeliac disease patients
Authors: Lukina Polina , Andersen Ina Lervåg , Eggen Petter Tinbod , Mjønes Patricia Gjertrud , Rønne Elin , Bolstad Nils , Klaasen Rolf Anton , Warren David J , Iversen Rasmus , Hveem Kristian , Bernklev Tomm , Jelsness-Jørgensen Lars Petter , Pedersen Lise , Jonkers Iris , Lagergren Pernilla , Sollid Ludvig Magne , Lundin Knut , Ness-Jensen Eivind
Published: January 2024

Purpose

Coeliac disease (CD) is a common disorder and affects about 1% of the population worldwide. CD in the Trøndelag Health Study (HUNT) is a population-based cohort study which was established to provide new knowledge about CD that can improve the diagnostics and management, prevent the onset or progression and expand the knowledge about the role of genetics of the disease.

Participants

The cohort is based on the fourth wave of the population-based HUNT study (HUNT4), Norway, performed during 2017–2019, also including linkage to hospital records and the Norwegian Patient Registry (NPR). A total of 54 541 HUNT4 participants with available sera were screened for CD by serology. All seropositive participants were invited to a clinical assessment, including endoscopy with duodenal biopsies, during 2019–2023.

Findings to date

A total of 1107 HUNT4 participants (2%) were seropositive for CD and 1048 were eligible for clinical assessment, including biopsy. Of these, 724 participants attended the clinical assessment and 482 were identified with CD. In addition, 371 participants with CD were identified through the hospital records and NPR. In total, 853 participants in HUNT4 with biopsy-verified CD diagnosis were identified.

Future plans

All participants in the study will be invited to a follow-up assessment after at least 1 year, including repeated standard serological testing, endoscopy and tissue sampling. The collected data and material will be used to establish the true population-based prevalence of CD. The consequences of CD, including symptoms, deficiencies and comorbidity, will be investigated and possible triggers and predictors, will be studied. With access to serum samples from the previous HUNT surveys in HUNT Biobank, serological signs of CD in prediagnostic samples of seropositive individuals will be used. Genetic studies will identify new CD markers, assess genotype–phenotype links and explore gene–environment correlations.

Registration

clinicaltrials.gov identifier:NCT04041622.
Realist synthesis protocol on the effectiveness of a rapid response system in managing mental state deterioration in acute hospital settings
Authors: Dziruni Tendayi Bruce , Hutchinson Alison M , Keppich-Arnold Sandra , Bucknall Tracey
Published: January 2024

Introduction

Patient mental state deterioration impacts patient outcomes, staff and increases costs for healthcare organisations. Mental state is broadly defined to include not only mental health but a broad range of cognitive, emotional and psychological well-being factors. Mental state deterioration is inconsistently identified and managed within acute and tertiary medical settings. This protocol aims to synthesise the evidence to test and refine initial programme theories that outline the functioning of a rapid response system.

Methods and analysis

This synthesis will be guided by Pawson’s key steps in realist reviews. We will clarify the scope of synthesis through an initial literature search, focusing on understanding the functioning of rapid response system in managing patients presenting with mental state deterioration in acute hospital settings. Initial programme theories will be refined by developing a search strategy to comprehensively search electronic databases for relevant English language peer-reviewed studies. Additionally, we will search the grey literature for sources to supplement theory testing. An abstraction form will be developed to record the characteristics of literature sources. We will use spreadsheets to code and report contextual factors, underlying mechanisms, and outcome configurations.

Ethics and dissemination

As this study is a realist synthesis protocol, ethics approval is not required. Synthesis findings will be published in a peer-reviewed journal and presented at scientific conferences.
Feasibility and acceptability of offering breast cancer risk assessment to general population women aged 30–39 years: a mixed-methods study protocol
Authors: Hindmarch Sarah , Howell Sacha J , Usher-Smith Juliet A , Gorman Louise , Evans D Gareth , French David P
Published: January 2024

Introduction

Breast cancer incidence starts to increase exponentially when women reach 30–39 years, hence before they are eligible for breast cancer screening. The introduction of breast cancer risk assessment for this age group could lead to those at higher risk receiving benefits of earlier screening and preventive strategies. Currently, risk assessment is limited to women with a family history of breast cancer only. The Breast CANcer Risk Assessment in Younger women (BCAN-RAY) study is evaluating a comprehensive breast cancer risk assessment strategy for women aged 30–39 years incorporating a questionnaire of breast cancer risk factors, low-dose mammography to assess breast density and polygenic risk. This study will assess the feasibility and acceptability of the BCAN-RAY risk assessment strategy.

Methods and analysis

This study involves women undergoing risk assessment as part of the BCAN-RAY case-control study (n=750). They will be aged 30–39 years without a strong family history of breast cancer and invited to participate via general practice. A comparison of uptake rates by socioeconomic status and ethnicity between women who participated in the BCAN-RAY study and women who declined participation will be conducted. All participants will be asked to complete self-report questionnaires to assess key potential harms including increased state anxiety (State Trait Anxiety Inventory), cancer worry (Lerman Cancer Worry Scale) and satisfaction with the decision to participate (Decision Regret Scale), alongside potential benefits such as feeling more informed about breast cancer risk. A subsample of approximately 24 women (12 at average risk and 12 at increased risk) will additionally participate in semistructured interviews to understand the acceptability of the risk assessment strategy and identify any changes needed to it to increase uptake.

Ethics and dissemination

Ethical approval was granted by North West—Greater Manchester West Research Ethics Committee (reference: 22/NW/0268). Study results will be disseminated through peer-reviewed journals, conference presentations and charitable organisations.

Trial registration number

NCT05305963.
Impact of multimorbidity and complex multimorbidity on healthcare utilisation in older Australian adults aged 45 years or more: a large population-based cross-sectional data linkage study
Authors: Kabir Alamgir , Conway Damian P , Ansari Sameera , Tran An , Rhee Joel J , Barr Margo
Published: January 2024

Objectives

As life expectancy increases, older people are living longer with multimorbidity (MM, co-occurrence of ≥2 chronic health conditions) and complex multimorbidity (CMM, ≥3 chronic conditions affecting ≥3 different body systems). We assessed the impacts of MM and CMM on healthcare service use in Australia, as little was known about this.

Design

Population-based cross-sectional data linkage study.

Setting

New South Wales, Australia.

Participants

248 496 people aged ≥45 years who completed the Sax Institute’s 45 and Up Study baseline questionnaire.

Primary outcome

High average annual healthcare service use (≥2 hospital admissions, ≥11 general practice visits and ≥2 emergency department (ED) visits) during the 3-year baseline period (year before, year of and year after recruitment).

Methods

Baseline questionnaire data were linked with hospital, Medicare claims and ED datasets. Poisson regression models were used to estimate adjusted and unadjusted prevalence ratios for high service use with 95% CIs. Using a count of chronic conditions (disease count) as an alternative morbidity metric was requested during peer review.

Results

Prevalence of MM and CMM was 43.8% and 15.5%, respectively, and prevalence increased with age. Across three healthcare settings, MM was associated with a 2.02-fold to 2.26-fold, and CMM was associated with a 1.83-fold to 2.08-fold, increased risk of high service use. The association was higher in the youngest group (45–59 years) versus the oldest group (≥75 years), which was confirmed when disease count was used as the morbidity metric in sensitivity analysis.

When comparing impact using three categories with no overlap (no MM/CMM, MM with no CMM, and CMM), CMM had greater impact than MM across all settings.

Conclusion

Increased healthcare service use among older adults with MM and CMM impacts on the demand for primary care and hospital services. Which of MM or CMM has greater impact on risk of high healthcare service use depends on the analytic method used. Ageing populations living longer with increasing burdens of MM and CMM will require increased Medicare funding and provision of integrated care across the healthcare system to meet their complex needs.
Impact of COVID-19 on diabetes care: mixed methods study in an Indigenous area of Guatemala
Authors: Guarchaj Magdalena , Tschida Scott , Milian Chew Juanita Patricia , Aguilar Andrea , Flood David , Fort Meredith P , Morales Lidia Cristina , Mendoza Montano Carlos , Rodríguez Serrano Silvia Nineth , Rohloff Peter
Published: January 2024

Introduction

SARS-CoV-2 has impacted globally the care of chronic diseases. However, direct evidence from certain vulnerable communities, such as Indigenous communities in Latin America, is missing. We use observational data from a health district that primarily serves people of Maya K’iche’ ethnicity to examine the care of type 2 diabetes in Guatemala during the pandemic.

Methods

We used a parallel convergent mixed methods design. Quantitative data (n=142 individuals with diabetes) included glycated haemoglobin (HbA1c), blood pressure, body mass index and questionnaires on diabetes knowledge, self-care and diabetes distress. Quantitative data was collected at two points, at baseline and after COVID restrictions were lifted. For quantitative outcomes, we constructed multilevel mixed effects models with multiple imputation for missing data. Qualitative data included interviews with providers, supervisors and individuals living with diabetes (n=20). We conducted thematic framework analysis using an inductive approach.

Results

Quantitative data was collected between June 2019 and February 2021, with a median of 487 days between data collection points. HbA1c worsened +0.54% (95% CI, 0.14 to 0.94) and knowledge about diabetes decreased −3.54 points (95% CI, −4.56 to –2.51). Qualitatively, the most important impact of the pandemic was interruption of the regular timing of home visits and peer group meetings which were the standard of care.

Conclusions

The deterioration of diabetes care was primarily attributed to the loss of regular contact with healthcare workers. The results emphasize the vulnerability of rural and Indigenous populations in Latin America to the suspension of chronic disease care.