Heart and Blood Diseases

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Rare Diseases

Heart Failure

Lung Neoplasms

Dyspnea

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Chronic Graft Versus Host Disease

Breathlessness Intervention Service (BIS) consists of a clinical specialist physiotherapist \& palliative care consultant. It aims to manage the symptom of breathlessness in patients with any disease (cancer \& non-cancer) using a rehabilitative approach. Interventions include: evidence-based non-pharmacological interventions (psychological, social \& physical); palliative care input (e.g. end of life issues, psychosocial issues, family concerns); \& pharmacological review. Thus BIS seeks to enhance the self-management of breathlessness. Uniquely, care is located in clinic or in patients' own homes, as appropriate. Referrals come from medical specialists, GPs \& allied health professionals (with medical consent).

Breathlessness Intervention Service

Standard care: specialist outpatient appointments in secondary care (e.g. respiratory, cardiology, neurology or oncology) which may include specialist nurse input, and primary care services.

Best supportive care (Standard Care)

Sara Booth, FRCP

Morag C Farquhar, PhD

The aim of this study is to evaluate the impact of a Breathlessness Intervention Service (BIS) on the quality of life of patients and families affected by intractable breathlessness. The questions to be addressed by this research are:

1. Is BIS more effective than standard care for patients with intractable breathlessness from advanced malignant or non-malignant disease?
2. Does it reduce patient and carer distress due to breathlessness, and increase patients' sense of mastery of the symptom?
3. What are the experiences and views of those who use BIS, their informal carers and the clinicians who refer to it?
4. Does BIS offer value for money for the NHS?

Research questions:

1. Is BIS more effective than standard care for patients with intractable breathlessness from advanced malignant or non-malignant disease?
2. Does it reduce patient \& carer distress due to breathlessness, \& increase patients' sense of mastery of the symptom?
3. What are the experiences \& views of those who use BIS, their informal carers \& the clinicians who refer to it?
4. Is BIS cost-effective?

To assess changes in patient outcomes attributable to BIS, a pragmatic RCT design will be conducted using a fast-track design (design proved highly acceptable at Phase II). Analysis will focus on comparing patients who have used BIS to those who have not (yet) used BIS (the use of BIS by the control group will occur subsequent to these measurement points).

The researcher will be blinded to the allocation of respondents up until discharge/referral on from BIS for FT patients or at the end of the waiting period for CC patients. This will be achieved by the researcher conducting study recruitment \& collecting baseline measures before instructing a third party (local clinical trials' nurse) to conduct randomisation \& reporting of allocation (to the patient \& BIS) using a random sequence of opaque envelopes previously generated by a statistician independent of BIS. Subsequently, all data will be handled using study identity numbers; group allocation identifiers will only be added at analysis. This model was used successfully in the Phase II pilot trial.

Data collected from the control group once they are in receipt of BIS (after their period on the waiting list when their group allocation was blinded to the researcher) will be treated as before/after data \& not RCT data. This will allow the collection of qualitative data from this group at the midpoint of using BIS.

The two broad disease courses, malignant (m) \& non-malignant (nm), will be considered separately due to their different trajectories \& needs, \& resultant different service models. The intervention model for patients with non-malignant disease consists of two-three visits \& three telephone contacts (to patient \&/or primary care staff) over a four-week period with a 16 week (from first assessment) follow up, whereas the model for patients with malignant disease consists of one visit in conjunction with a primary care professional/key worker \& two telephone contacts (to patient \&/or primary care staff/key worker) over a two-week period, with a six week (from first assessment) follow up . Thus, the measurement points for the disease groups will differ.

Data (quantitative/qualitative) will be collected for all respondents at baseline (t1), prior to randomisation. For those with non-malignant conditions (nm), this will be repeated for the FT group (nmFT) midway through the intervention (two weeks post commencing BIS; nmFTt2 - quantitative data only) \& at the equivalent time point for the CC group (i.e. two weeks from entering the waiting list; nmCCt2 - quantitative data only), then again after discharge/referral on from BIS for the fast track group (four weeks post commencing BIS; nmFTt3) \& four weeks after discharge (nmFTt5). As well as being interviewed at t1 (randomisation) \& t2 (midway between randomisation \& BIS - quantitative data only), the CC group (nmCC) will also be interviewed just prior to commencing BIS (nmCCt3), during BIS (two weeks post commencing BIS; nmCCt4) \& then again after discharge/referral on from BIS (four weeks post commencing BIS (nmCCt5). This will allow identification of whether or not respondents in the control group deteriorated significantly whilst waiting for BIS \& the impact of this on final outcomes. This model was successfully piloted at Phase II.

For those with malignant conditions (m), baseline measures (t1) will be repeated for the FT group (mFT) after discharge/referral on from BIS (two weeks post commencement of BIS; mFTt3) \& two weeks after discharge (mFTt5). For the CC group (mCC) baseline measures (t1) will be repeated just prior to commencing BIS (mCCt3) \& then again after discharge/referral on from BIS (two weeks post commencing BIS; mCCt5). Thus, due to the shorter time frame of the malignant service model, there would be no t2 or t4 measurement points.

Sample size is based on the existing literature \& on our experiences at Phase II. The estimated standard deviation of the primary outcome measure is 2.5. In order to detect a 2-point difference in mean outcome between groups (equivalent to 0.8sd effect size) with 80% power using a t-test at the 5% level of significance, it will be necessary to recruit 26 patients per arm per disease group (trial) followed up to provide an outcome, which will now be at an earlier time point to minimize attrition. By adjusting for the baseline of the primary outcome measure in the analysis using analysis of covariance we anticipate an improvement in the precision of the estimated intervention effect. We also anticipate an improvement from the use in the trial of the NRS measure rather than the more highly variable VAS version from the pilot used in this sample size calculation. Therefore we propose to recruit 120 patients, 60 per disease group to ensure adequate power, effect size and allowance for attrition.

Analysis will be on an intention to treat basis. Primary analysis will be by analysis of covariance of the NRS at the final time-point with adjustment for baseline NRS in order to improve precision of the estimated BIS versus comparison effect. Secondary analysis will more sensitively incorporate all time-points in a repeated measures linear regression to be able to detect any differences between BIS \& comparison emerging/changing over time within the initial period. All analysis will be documented prior to final data collection in an analysis plan, will be addressed with two-tailed tests \& be assessed at the 5% level of significance. Effects within \& between arms will be summarized using means \& 95% confidence intervals. If randomised effects are similar in malignant \& non-malignant groups, a combined effect will be estimated allowing a narrower overall confidence interval. Analysis will be conducted using SPSS software.

The cost of BIS for each patient will be calculated from service activity data combined with staff salary costs, plus on-costs, overheads \& equipment. Information on the use of other health \& social services \& informal care (proxy-valued as a homecare worker) will be collected with the Client Service Receipt Inventory. This will be combined with appropriate unit cost data (Curtis \& Netten, 2006) to generate service costs. Cost comparisons will be made using bootstrapping methods to account for any skewness in data distribution. Cost-effectiveness will be assessed by combining cost data with that on outcomes including quality-adjusted life years (QALYS), in the form of incremental cost-effectiveness ratio \& acceptability curves. Qualitative data will be analysed using a framework approach (Ritchie \& Spencer, 1993) conducted using NVivo software.

Trial of a Breathlessness Intervention Service for Intractable Breathlessness

Phase III Randomized Controlled Trial of a Breathlessness Intervention Service for Intractable Breathlessness.

University of Cambridge

King's College London

Cambridge University Hospitals NHS Foundation Trust

Dr Sara Booth

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Infections

Kidney Diseases

Diabetes Mellitus

COVID-19

Hypertension

Noncommunicable Diseases

Renal Insufficiency, Chronic

Renal Insufficiency

Pneumonia

Pneumonia, Viral

Communicable Diseases

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

The intervention of the study is the COVID-19 outbreaks in Hong Kong. The pre-and post-COVID-19 outbreak periods will be defined as 1 January 2010 - 31 December 2019 and 1 January 2020 - 31 December 2024, respectively.

COVID-19 outbreaks

Cindy L.K. Lam, MD

Eric Y.F Wan, PhD

Objectives and aim: To evaluate the long-term spill-over (indirect) effect of Coronavirus disease (COVID-19) on health outcomes and healthcare utilization among people with non-communicable diseases and without COVID-19.

Design: A population-based cohort study using electronic health records of the Hospital Authority (HA) clinical management system, economic modeling, and serial cross-sectional surveys on healthcare service utilization.

Setting: HA public hospitals and outpatient clinics in Hong Kong

Participants: People aged ≥ 18 years with a documented diagnosis of diabetes mellitus, hypertension, cardiovascular disease, cancer, chronic respiratory disease, and chronic kidney disease; without COVID-19; attending HA services between 2010 and 2024.

Main outcome measures: All-cause mortality, disease-specific outcomes, healthcare service utilization, and costs.

Methods: The annual incidence of each outcome in each year between 2010 and 2024 will be calculated. An interrupted time-series analysis to assess the changes in outcomes between pre-and-post-COVID-19 outbreak periods. Long term health economic impact of healthcare disruptions during the COVID-19 outbreak will be modeled using microsimulation. Multivariable Cox proportional hazards regression and Poisson/negative binomial regression to evaluate the effect of different modes of care on the risk of the outcomes.

Implications: Findings will inform policies and practices on contingency care plans to avoid excessive morbidity and mortality and to assure the quality of care for patients with NCD as part of the territorial response to the health crisis.

This study aims to evaluate the spill-over impact of the COVID-19 outbreak on health outcomes, healthcare utilization, and costs in patients with major non-communicable diseases (NCDs). The study will include six leading NCDs (diabetes mellitus, hypertension, cardiovascular diseases (CVD), cancer, chronic kidney diseases (CKD), chronic respiratory diseases) representing the most prevalent conditions and the major causes of deaths in Hong Kong. The objectives of the study are the following:

1. To determine changes in all-cause mortality, disease-specific outcomes, and healthcare utilization rates and costs among major NCD patients during the pre-and post- COVID-19 outbreak.
2. To assess the long-term health economic impact of COVID-19 on health outcomes and healthcare utilization rates and costs among major NCD patients by conducting an in-depth economic evaluation
3. To explore the impact of different modes of care on all-cause mortality, disease-specific outcomes, and healthcare utilization rates and costs among major NCD patients during the post-COVID-19 period.

This study consists of two study designs.

1. It is a retrospective cohort study using data extracted from the electronic medical records of the Hong Kong Hospital Authority (HA) Clinical Management System (CMS) from 1 January 2010 to 31 December 2024.

   * Anonymous data including socio-demographics, disease-specific parameters identified by International Classification of Primary Care, 2nd edition (ICPC-2) and the International Classification of Diseases, 9th revision, Clinical Modification (ICD-9-CM) will be extracted by the Hospital Authority statistics. There will be two phases of data extraction for the data collected in the periods 2010-2021 and 2022-2024.
2. The investigators will carry out two serial cross-sectional surveys on self-reported healthcare service utilization in the second and fourth years after the COVID-19 outbreak.

   * Two surveys will be conducted for patients with the major NCD recruited from outpatient clinics to collect data on healthcare service utilization patterns and rates in the years of 2020 and 2022 using a structured questionnaire.

The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of People With Non-communicable Diseases

The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of Patients With Non-communicable Diseases (and Without COVID-19) : an In-depth Outcome and Health Economic Evaluation

Years of life lost (YLL), quality-adjusted life year (QALY), and disability-adjusted life year (DALY) attributable to delayed care resulting from the COVID-19 outbreak. Based on life expectancy for 10-year ages groups from the Census and Statistics Department life tables for 2017-19.

Incidence of all-cause mortality, and disease-specific complications (cardiovascular disease, end-stage renal disease, retinopathy, neuropathy and all-cause mortality) The disease are defined by the diagnosis codes International Classification of Primary Care, Second edition or International Classification of Diseases,Ninth Revision, Clinical Modification.

Utilization rates and costs for public and private healthcare services including hospitalization (episodes, modes of admission and length of stay), specialist and general outpatient consultations (number of visits, modes of consultations, western/Chinese medicine), and Accident \& Emergency Department (AED) attendances (triage urgency level for AED attendances at public hospital).

The University of Hong Kong

Clinical Professor, Chairperson of Department of Family Medicine & Primary Care

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of a Breathlessness Intervention Service for Intractable Breathlessness	NCT00678405	Dyspnea	Breathlessness ... Best supportive...	18 Years -	Cambridge University Hospitals NHS Foundation Trust
The Long-term Spill-over Impact of COVID-19 on Health and Healthcare of People With Non-communicable Diseases	NCT05248412	Diabetes Mellit... Hypertension Cancer Cardiovascular ... Chronic Respira... Kidney Disease,... Noncommunicable...	COVID-19 outbre...	18 Years -	The University of Hong Kong

Spots Global Cancer Trial Database for chronic respiratory disease