The objective of this study was to find relevant concepts of functioning in community-dwelling older adults within frequently used assessment instruments published in the scientific literature. This was part of a larger project to develop an International Classification of Functioning, Disability and Health (ICF) Core Set for use in primary care.
A scoping review was conducted. Articles dealing with functioning in older adults were searched and assessed for eligibility. The study population included community-dwelling adults (≥75 years) without dementia, living in high-resource countries. Relevant concepts were extracted from assessment instruments and linked to the ICF using standardised linking rules. Finally, a frequency analysis was conducted.
Home, primary care.
Community-dwelling adults aged 75 years and above.
From 5060 identified publications, 68 were included and 30 assessment instruments extracted. Overall, 1182 concepts were retrieved. Most were linked to the ‘activities and participation’ component. The most frequently identified categories were ‘memory functions’, ‘dressing’ and ‘changing basic body position’.
This review provides a list of relevant ICF categories from the research perspective that will be used for developing an ICF Core Set for older primary care patients.
PROSPERO (CRD42017067784), Versorgungsforschung Deutschland Datenbank (VfD_17_003833) and ClinicalTrials.gov (NCT03384732).
To examine non-communicable diseases (NCDs) multimorbidity level and its relation to households’ socioeconomic characteristics, health service use, catastrophic health expenditures and productivity loss.
This study used panel data of the Indonesian Family Life Survey conducted in 2007 (Wave 4) and 2014 (Wave 5).
The original sampling frame was based on 13 out of 27 provinces in 1993, representing 83% of the Indonesian population.
We included respondents aged 50 years and above in 2007, excluding those who did not participate in both Waves 4 and 5. The total number of participants in this study are 3678 respondents.
We examined three main outcomes; health service use (outpatient and inpatient care), financial burden (catastrophic health expenditure) and productivity loss (labour participation, days primary activity missed, days confined in bed). We applied multilevel mixed-effects regression models to assess the associations between NCD multimorbidity and outcome variables,
Women were more likely to have NCD multimorbidity than men and the prevalence of NCD multimorbidity increased with higher socioeconomic status. NCD multimorbidity was associated with a higher number of outpatient visits (compared with those without NCD, incidence rate ratio (IRR) 4.25, 95% CI 3.33 to 5.42 for individuals with >3 NCDs) and inpatient visits (IRR 3.68, 95% CI 2.21 to 6.12 for individuals with >3 NCDs). NCD multimorbidity was also associated with a greater likelihood of experiencing catastrophic health expenditure (for >3 NCDs, adjusted OR (aOR) 1.69, 95% CI 1.02 to 2.81) and lower participation in the labour force (aOR 0.23, 95% CI 0.16 to 0.33) compared with no NCD.
NCD multimorbidity is associated with substantial direct and indirect costs to individuals, households and the wider society. Our study highlights the importance of preparing health systems for addressing the burden of multimorbidity in low-income and middle-income countries.
There is evidence that BCG immunisation may protect against unrelated infectious illnesses. This has led to the postulation that administering BCG before unrelated vaccines may enhance responses to these vaccines. This might also model effects of BCG on unrelated infections.
To test this hypothesis, we have designed a randomised controlled trial of BCG versus no BCG immunisation to determine the effect of BCG on subsequent unrelated vaccines, among 300 adolescents (aged 13–17 years) from a Ugandan birth cohort. Our schedule will comprise three main immunisation days (week 0, week 4 and week 28): BCG (or no BCG) revaccination at week 0; yellow fever (YF-17D), oral typhoid (Ty21a) and human papillomavirus (HPV) prime at week 4; and HPV boost and tetanus/diphtheria (Td) boost at week 28. Primary outcomes are anti-YF-17D neutralising antibody titres, Salmonella typhi lipopolysaccharide-specific IgG concentration, IgG specific for L1-proteins of HPV-16/HPV-18 and tetanus and diphtheria toxoid-specific IgG concentration, all assessed at 4 weeks after immunisation with YF, Ty21a, HPV and Td, respectively. Secondary analyses will determine effects on correlates of protective immunity (where recognised correlates exist), on vaccine response waning and on whether there are differential effects on priming versus boosting immunisations. We will also conduct exploratory immunology assays among subsets of participants to further characterise effects of BCG revaccination on vaccine responses. Further analyses will assess which life course exposures influence vaccine responses in adolescence.
Ethics approval has been obtained from relevant Ugandan and UK ethics committees. Results will be shared with Uganda Ministry of Health, relevant district councils, community leaders and study participants. Further dissemination will be done through conference proceedings and publications.
Gallbladder cancer (GBC), the sixth most common gastrointestinal tract cancer, poses a significant disease burden in China. However, no national representative data are available on the clinical characteristics, treatment and prognosis of GBC in the Chinese population.
The Chinese Research Group of Gallbladder Cancer (CRGGC) study is a multicentre retrospective registry cohort study. Clinically diagnosed patient with GBC will be identified from 1 January 2008 to December, 2019, by reviewing the electronic medical records from 76 tertiary and secondary hospitals across 28 provinces in China. Patients with pathological and radiological diagnoses of malignancy, including cancer in situ, from the gallbladder and cystic duct are eligible, according to the National Comprehensive Cancer Network 2019 guidelines. Patients will be excluded if GBC is the secondary diagnosis in the discharge summary. The demographic characteristics, medical history, physical examination results, surgery information, pathological data, laboratory examination results and radiology reports will be collected in a standardised case report form. By May 2021, approximately 6000 patient with GBC will be included. The clinical follow-up data will be updated until 5 years after the last admission for GBC of each patient. The study aimed (1) to depict the clinical characteristics, including demographics, pathology, treatment and prognosis of patient with GBC in China; (2) to evaluate the adherence to clinical guidelines of GBC and (3) to improve clinical practice for diagnosing and treating GBC and provide references for policy-makers.
The protocol of the CRGGC has been approved by the Committee for Ethics of Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (SHEC-C-2019–085). All results of this study will be published in peer-reviewed journals and presented at relevant conferences.
Despite evidence that illustrates the unmet healthcare needs of older adults, there is limited research examining their help-seeking behaviour, of which direct intervention can improve patient outcomes. Research in this area conducted with a focus on ethnic minority older adults is also needed, as their help-seeking behaviours may be influenced by various cultural factors. This scoping review aims to explore the global literature on the factors associated with help-seeking behaviours of older adults and how cultural values and backgrounds may impact ethnic minority older adults’ help-seeking behaviours in different ways.
The scoping review process will be guided by the methodology framework of Arksey and O’Malley and the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols Extension for Scoping Reviews guidelines. The following electronic databases will be systematically searched from January 2005 onwards: MEDLINE/PubMed, Web of Science, PsycINFO, CINAHL and Scopus. Studies of various designs and methodologies consisting of older adults aged 65 years or older, who are exhibiting help-seeking behaviours for the purpose of remedying a physical or mental health challenge, will be considered for inclusion. Two reviewers will screen full texts and chart data. The results of this scoping review will be summarised quantitatively through numerical counts and qualitatively through a narrative synthesis.
As this is a scoping review of published literature, ethics approval is not required. Results will be disseminated through publication in a peer-reviewed journal.
This scoping review will synthesise the current literature related to the help-seeking behaviours of older adults and ethnic minority older adults. It will identify current gaps in research and potential ways to move forward in developing or implementing strategies that support the various health needs of the diverse older adult population.
This scoping review protocol has been registered with the Open Science Framework (https://osf.io/69kmx).
The objective of this study was to explore the impact of Taiwan’s Family Practice Integrated Care Project (FPICP) on hospitalisation.
A population-based cohort study compared the hospitalisation rates for ambulatory care sensitive conditions (ACSCs) among FPICP participating and non-participating patients during 2011–2015.
The study accessed the FPICP reimbursement database of Taiwan’s National Health Insurance (NHI) administration containing all NHI administration-selected patients for FPICP enrolment.
The NHI administration-selected candidates from 2011 to 2015 became FPICP participants if their primary care physicians joined the project, otherwise they became non-participants.
The intervention of interest was enrolment in the FPICP or not. The follow-up time interval for calculating the rate of hospitalisation was the year in which the patient was selected for FPICP enrolment or not.
The study’s primary outcome measures were hospitalisation rates for ACSC, including asthma/chronic obstructive pulmonary disease (COPD), diabetes or its complications and heart failure. Logistic regression was used to calculate the ORs concerning the influence of FPICP participation on the rate of hospitalisation for ACSC.
The enrolled population for data analysis was between 3.94 and 5.34 million from 2011 to 2015. Compared to non-participants, FPICP participants had lower hospitalisation for COPD/asthma (28.6–35.9 vs 37.9–42.3) and for diabetes or its complications (10.8–14.9 vs 12.7–18.1) but not for congestive heart failure. After adjusting for age, sex and level of comorbidities by logistic regression, participation in the FPICP was associated with lower hospitalisation for COPD/asthma (OR 0.91, 95% CI 0.87 to 0.94 in 2015) and for diabetes or its complications (OR 0.87, 95% CI 0.83 to 0.92 in 2015).
Participation in the FPICP is an independent protective factor for preventable ACSC hospitalisation. Team-based community healthcare programs such as the FPICP can strengthen primary healthcare capacity.
The high placebo response in depression treatment trials is a major contributing factor for randomised control trial failure to establish efficacy of novel or repurposed treatments in treatment-resistant depression (TRD) and major depressive disorder in general. Though there have been a number of meta-analyses and primary research studies evaluating the placebo response in non-TRD, placebo response in TRD is poorly understood. It is important to understand the placebo response of TRD as treatments are only moderately effective and up to 1/3 of patients will experience TRD.
We will conduct a search of electronic databases (MEDLINE and PsychINFO) from inception to 24th January 2020 including randomised, placebo-controlled trials of pharmacological, somatic and psychological interventions for adults with TRD. TRD will be defined as a failure to respond to at least two interventions of adequate dose or duration. We will also search reference lists from review articles. We will perform several meta-analyses to quantify the placebo response for each treatment modality. Regression analysis will explore potential contributing demographic and clinical variables to the placebo response. We will use Cochrane risk of bias tool.
There is no research ethics board approval required. The dissemination plan is to publish results in a peer-reviewed academic journal.
The Healthy Life Trajectories Initiative is an international consortium comprising four harmonised but independently powered trials to evaluate whether an integrated intervention starting preconceptionally will reduce non-communicable disease risk in their children. This paper describes the protocol of the India study.
The study set in rural Mysore will recruit ~6000 married women over the age of 18 years. The village-based cluster randomised design has three arms (preconception, pregnancy and control; 35 villages per arm). The longitudinal multifaceted intervention package will be delivered by community health workers and comprise: (1) measures to optimise nutrition; (2) a group parenting programme integrated with cognitive–behavioral therapy; (3) a lifestyle behaviour change intervention to support women to achieve a diverse diet, exclusive breast feeding for the first 6 months, timely introduction of diverse and nutritious infant weaning foods, and adopt appropriate hygiene measures; and (4) the reduction of environmental pollution focusing on indoor air pollution and toxin avoidance.
The primary outcome is adiposity in children at age 5 years, measured by fat mass index. We will report on a host of intermediate and process outcomes. We will collect a range of biospecimens including blood, urine, stool and saliva from the mothers, as well as umbilical cord blood, placenta and specimens from the offspring.
An intention-to-treat analysis will be adopted to assess the effect of interventions on outcomes. We will also undertake process and economic evaluations to determine scalability and public health translation.
The study has been approved by the institutional ethics committee of the lead institute. Findings will be published in peer-reviewed journals. We will interact with policy makers at local, national and international agencies to enable translation. We will also share the findings with the participants and local community through community meetings, newsletters and local radio.
ISRCTN20161479, CTRI/2020/12/030134; Pre-results.
Drivers of lower vaccine efficacy and impaired vaccine-specific immune responses in low-income versus high-income countries, and in rural compared with urban settings, are not fully elucidated. Repeated exposure to and immunomodulation by parasite infections may be important. We focus on Plasmodium falciparum malaria, aiming to determine whether there are reversible effects of malaria infection on vaccine responses.
We have designed a randomised, double-blind, placebo-controlled, parallel group trial of intermittent preventive malaria treatment versus placebo, to determine effects on vaccine response outcomes among school-going adolescents (9 to 17 years) from malaria-endemic rural areas of Jinja district (Uganda). Vaccines to be studied comprise BCG vaccine on day ‘zero’; yellow fever, oral typhoid and human papilloma virus vaccines at week 4; and tetanus/diphtheria booster vaccine at week 28. Participants in the intermittent preventive malaria treatment arm will receive dihydroartemisinin/piperaquine (DP) dosed by weight, 1 month apart, prior to the first immunisation, followed by monthly treatment thereafter. We expect to enrol 640 adolescents. Primary outcomes are BCG-specific interferon- ELISpot responses 8 weeks after BCG immunisation and for other vaccines, antibody responses to key vaccine antigens at 4 weeks after immunisation. In secondary analyses, we will determine effects of monthly DP treatment (versus placebo) on correlates of protective immunity, on vaccine response waning, on whether there are differential effects on priming versus boosting immunisations, and on malaria infection prevalence. We will also conduct exploratory immunology assays among subsets of participants to further characterise effects of the intervention on vaccine responses.
Ethics approval has been obtained from relevant Ugandan and UK ethics committees. Results will be shared with Uganda Ministry of Health, relevant district councils, community leaders and study participants. Further dissemination will be done through conference proceedings and publications.
Current Controlled Trials identifier: ISRCTN62041885.
Sensory impairments are associated with worse mental health and poorer quality of life, but few studies have investigated whether sensory impairment is associated with suicidal behaviour in a population sample. We investigated whether visual and hearing impairments were associated with suicidal ideation and attempt.
National cross-sectional study.
Households in England.
We analysed data for 7546 household residents in England, aged 16 and over from the 2014 Adult Psychiatric Morbidity Survey.
Sensory impairment (either visual or hearing), Dual sensory impairment (visual and hearing), visual impairment, hearing impairment.
Suicidal ideation and suicide attempt in the past year.
People with visual or hearing sensory impairments had twice the odds of past-year suicidal ideation (OR 2.06; 95% CI 1.17 to 2.73; p
We found evidence that individuals with sensory impairments are more likely to have thought about or attempted suicide in the past year than individuals without.
Whether ACE inhibitors (ACEi) or angiotensin II receptor blocker (ARB) therapy should be continued, initiated or ceased in patients with COVID-19 is uncertain. Given the widespread use of ACEi/ARBs worldwide, guidance on the use of these drugs is urgently needed. This prospective meta-analysis aims to pool data from randomised controlled trials (RCTs) to assess the safety and efficacy of ACEi/ARB therapy in adults infected with SARS-CoV-2.
RCTs will be eligible if they compare patients with COVID-19 randomised to ACEi/ARB continuation or commencement versuss no ACEi/ARB therapy; study duration ≥14 days; recruitment completed between March 2020 and May 2021. The primary outcome will be all-cause mortality at ≤30 days. Secondary outcomes will include mechanical ventilation, admission to intensive care or cardiovascular events at short-term follow-up (≤30 days) and all-cause mortality at longer-term follow-up (>1 month). Prespecified subgroup analyses will assess the effect of sex; age; comorbidities; smoking status; ethnicity; country of origin on all-cause mortality. A search of ClinicalTrials.gov has been performed, which will be followed by a formal search of trial registers, preprint servers, MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials to identify RCTs that meet inclusion criteria. To date, a search of ClinicalTrials.gov identified 21 potentially eligible trials for this meta-analysis. We will request trial investigators/sponsors to contribute standardised grouped tabular outcome data.
Ethics approval and informed consent will be the responsibility of the individual RCTs. Dissemination of results will occur by peer-reviewed publication. The results of our analysis can inform public health policy and clinical decision making regarding ACEi/ARB use in patients with COVID-19 on a global scale.
Nursing research competence of nursing personnel has received much attention in recent years, as nursing has developed as both an independent academic discipline and an evidence-based practiing profession. Instruments for appraising nursing research competence are important, as they can be used to assess nursing research competence of the target population, showing changes of this variable over time and measuring the effectiveness of interventions for improving nursing research competence. There is a need to map the current state of the science of the instruments for nursing research competence, and to identify well validated and reliable instruments. This paper describes a protocol for a scoping review to identify, evaluate, compare and summarise the instruments designed to measure nursing research competence.
The scoping review will be conducted following Arksey and O’Malley’s methodological framework and Levac et al’s additional recommendations for applying this framework. The scoping review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. The protocol is registered through the Open Science Framework (https://osf.io/ksh43/). Eight English databases and two Chinese databases will be searched between 1 December 2020 and 31 December 2020 to retrieve manuscripts which include instrument(s) of nursing research competence. The literature screening and data extraction will be conducted by two researchers, independently. A third researcher will be involved when consensus is needed. The COnsensus-based Standards for the selection of health Measurement INstruments methodology will be used to evaluate the methodological quality of the included studies on measurement properties of the instruments, as well as the quality of all the instruments identified.
Ethical approval is not needed. We will disseminate the findings through a conference focusing on nursing research competence and publication of the results in a peer-reviewed journal.
Despite treatment availability, chronic hepatitis C virus (HCV) public health burden is rising in India due to lack of timely diagnosis. Therefore, we aim to assess incremental cost per quality-adjusted life year (QALY) for one-time universal screening followed by treatment of people infected with HCV as compared with a no screening policy in Punjab, India.
Decision tree integrated with Markov model was developed to simulate disease progression. A societal perspective and a 3% annual discount rate were considered to assess incremental cost per QALY gained. In addition, budgetary impact was also assessed with a payer’s perspective and time horizon of 5 years.
Screening services were assumed to be delivered as a facility-based intervention where active screening for HCV cases would be performed at 22 district hospitals in the state of Punjab, which will act as integrated testing as well as treatment sites for HCV.
Two intervention scenarios were compared with no universal screening and treatment (routine care). Scenario I—screening with ELISA followed by confirmatory HCV-RNA quantification and treatment. Scenario II—screening with rapid diagnostic test (RDT) kit followed by confirmatory HCV-RNA quantification and treatment.
Lifetime costs; life years and QALY gained; and incremental cost-effectiveness ratio for each of the above-mentioned intervention scenario as compared with the routine care.
Screening with ELISA and RDT, respectively, results in a gain of 0.028 (0.008 to 0.06) and 0.027 (0.008 to 0.061) QALY per person with costs decreased by –1810 Indian rupees (–3376 to –867) and –1812 Indian rupees (–3468 to –850) when compared with no screening. One-time universal screening of all those ≥18 years at a base coverage of 30%, with ELISA and RDT, would cost 8.5 and 8.3 times more, respectively, when compared with screening the age group of the cohort 40–45 years old.
One-time universal screening followed by HCV treatment is a dominant strategy as compared with no screening. However, budget impact of screening of all ≥18-year-old people seems unsustainable. Thus, in view of findings from both cost-effectiveness and budget impact, we recommend beginning with screening the age cohort with RDT around mean age of disease presentation, that is, 40–45 years, instead of all ≥18-year-old people.
Young people who have been removed from their family home and placed in out-of-home care have commonly experienced abuse, neglect and/or other forms of early adversity. High rates of mental health difficulties have been well documented in this group. The aim of this research was to explore the experiences of these young people within the care system, particularly in relation to support-seeking and coping with emotional needs, to better understand feasible and acceptable ways to improve outcomes for these young people.
This study used 1:1 semistructured qualitative interviews with young people in out-of-home care in England, to provide an in-depth understanding of their views of coping and support for their emotional needs, both in terms of support networks and experiences with mental health services. Participants were 25 young people aged 10–16 years old (56% female), and included young people living with non-biological foster carers, kinship carers and in residential group homes.
Participants described positive (eg, feeling safe) and negative (eg, feeling judged) aspects to being in care. Carers were identified as the primary source of support, with a supportive adult central to coping. Views on support and coping differed for young people who were experiencing more significant mental health difficulties, with this group largely reporting feeling unsupported and many engaging in self-harm. The minority of participants had accessed formal mental health support, and opinions on usefulness were mixed.
Results provide insight, from the perspective of care-experienced young people, about both barriers and facilitators to help-seeking, as well as avenues for improving support.
Chronic kidney disease (CKD) is a common chronic disease. As this disease is extremely complex, multidisciplinary care (MDC) is needed to provide complete and continuous care.
A systematic literature review was performed to examine the constituents of MDC, the content of MDC interventions, and the health outcomes in CKD patients receiving MDC.
Searches of five Chinese and English databases for studies of CKD patients who had received MDC from 2007 to 2019 revealed 11 studies, which comprised 16,066 CKD patients. The Physiotherapy Evidence Database scale (Physiotherapy Evidence Database, 2017) was used to appraise study quality for randomized controlled trials, and the Joanna Briggs Institute Critical Appraisal tools (Joanna Briggs Institute, 2017) were for cohort studies.
The MDC teams that provided comprehensive medical care for these patients included nephrologists, nurses, surgeons, general practitioners, pharmacists, psychotherapists, social workers, nutritionists, and other specialists. The literature review revealed that MDC for CKD slows the decline in estimated glomerular filtration rate and decreases patient mortality, the risk of renal replacement therapy, the need for emergent dialysis, and annual medical costs. Analyses of biochemical markers in the CKD patients showed that MDC improves control of serum levels of calcium and phosphate, improves control of parathyroid hormone, and reduces proteinuria and fasting blood glucose values. However, further studies are needed to determine the effects of MDC on all‐cause mortality, blood pressure control, hospitalization rate, hospitalization for cardiovascular or infection events, medications use, and other biochemical markers in CKD patients.
Cross‐disciplinary collaboration of healthcare professionals is needed to ensure that patients undergo regular follow‐up and periodic assessment of clinical status, in addition to ensuring that relevant resources and assistance are provided in a timely manner. A follow‐up period of at least 2 years is also needed to ensure sufficient time to observe MDC results.
Prevalence rates of breastfeeding remain low even though the World Health Organization (WHO) and the American Academy of Pediatrics recommend exclusive breast feeding for the first 6 months of life in combination with appropriate complementary feeding beyond six 6 months of age. There have been several studies that address the implication of drinking animal milk and/or infant formula on children’s health and development when breast feeding is not offered during the first year of life. Vast improvements have been made in infant formula design, which may increase its benefits compared with animal’s milk. The objective of this review is therefore to synthesise the most recent evidence on the effects of the consumption of animal milk compared with infant formula in non-breastfed or mixed breastfed infants aged 6–11 months.
We will conduct a systematic review and meta-analysis of studies that assessed the effect of animal milk compared with formula or mixed-fed (breastmilk and formula) on infants aged 6–11 months. The primary outcomes of interest include anaemia, gastrointestinal blood loss, weight for age, height for age and weight for height. We will include randomised and non-randomised studies with a control group. We will use the Cochrane risk of bias tools to assess the risk of bias. We will use meta-analysis to pool findings if the identified studies are conceptually homogenous and data are available from more than one study. We will assess the overall quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach.
This is a systematic review, so no patients will be directly involved in the design or development of this study. The findings from this systematic review will be disseminated to relevant patient populations and caregivers and will guide the WHO’s recommendations on formula consumption versus animal milk in infants aged 6–11 months.
We sought to determine the extent of SARS-CoV-2 seroprevalence and the factors associated with seroprevalence across a diverse cohort of healthcare workers.
Observational cohort study of healthcare workers, including SARS-CoV-2 serology testing and participant questionnaires.
A multisite healthcare delivery system located in Los Angeles County.
A diverse and unselected population of adults (n=6062) employed in a multisite healthcare delivery system located in Los Angeles County, including individuals with direct patient contact and others with non-patient-oriented work functions.
Using Bayesian and multivariate analyses, we estimated seroprevalence and factors associated with seropositivity and antibody levels, including pre-existing demographic and clinical characteristics; potential COVID-19 illness-related exposures; and symptoms consistent with COVID-19 infection.
We observed a seroprevalence rate of 4.1%, with anosmia as the most prominently associated self-reported symptom (OR 11.04, p
The demographic factors associated with SARS-CoV-2 seroprevalence among our healthcare workers underscore the importance of exposure sources beyond the workplace. The size and diversity of our study population, combined with robust survey and modelling techniques, provide a vibrant picture of the demographic factors, exposures and symptoms that can identify individuals with susceptibility as well as potential to mount an immune response to COVID-19.
The measurement of fractional exhaled nitric oxide (FeNO) is promising for diagnosing asthma and might substitute for bronchial provocation (BP) tests. To evaluate the diagnostic accuracy of FeNO within a confirmatory study, the following hypotheses will be tested: (1) A FeNO cut-off >50 ppb (parts per billion) is suitable for diagnosing asthma (sensitivity 35%, specificity 95%); (2) If the clinical symptoms ‘allergic rhinitis’ and ‘wheezing’ are present, asthma can be diagnosed at FeNO >33 ppb with a positive predictive value (PPV)
A prospective diagnostic study will be conducted in three practices of pneumologists in Germany. 300 patients suspected of suffering from asthma will be included. As an index test, patients perform FeNO measurement with the device NIOX VERO. As reference a test, patients are examined with whole bodyplethysmography and BP, if necessary. After 3 months, patients with an asthma diagnosis will be examined again to verify the diagnosis and evaluate ICS responsiveness. Patients who did not receive an asthma diagnosis at the initial examination will be phoned after 3 months and asked about persistent respiratory symptoms to exclude false negative findings. As a primary target, sensitivity and specificity of FeNO >50 ppb will be determined. As a secondary target the PPV for asthma at FeNO >33 ppb, when the symptoms ‘allergic rhinitis’ and ‘wheezing’ are present, will be calculated. Regarding ICS responsiveness, the PPV of FeNO >33 ppb will be determined.
The study was approved by the Ethical Committee of the Technical University of Munich (Reference number 122/20 S). The major results will be published in peer-reviewed academic journals and disseminated through conferences.
An increasing number of systematic reviews and meta-analyses of clinical trials have begun to investigate the effects of exercise interventions in patients with chronic kidney disease (CKD). To systematically appraise and synthesise these results, we will conduct an overview of systematic reviews and meta-analyses.
This is a protocol for an overview of systematic reviews and meta-analyses. We will search four databases: PubMed, Embase, Web of Science Core Collection and Cochrane Central Registry of Controlled Trials. Systematic reviews and meta-analyses of clinical trials evaluating the effect of exercise interventions on patients with CKD will be included. Two independent authors will screen titles and abstracts retrieved in the literature search and select studies meeting the eligibility criteria for full-text review. The methodological quality of the included reviews will be assessed using A Measurement Tool to Assess Systematic Reviews-2. We estimate the summary effects for each meta-analyses based on the standardised mean difference and its 95% CI. Additionally, the heterogeneity will be assessed by I2 evidence of small-study effect and the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation system.
Ethics approval are not required as no private information from individuals is collected. The results will be published in a peer-reviewed journal or disseminated in relevant conferences.