Appendix
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Appendix 1: Use and doses of long-term inhaled bronchodilator and corticosteroids determined in response trials
Response | Drug | Dose (mcg) | Frequency | Delivery |
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beta-agonist | |||
Salbutamol | 100-200mcg | 4-6-hourly | MDI/spacer | |
Salbutamol | 200-400mcg | 4-6-hourly | DPI | |
Terbutaline | 500-1500mcg | 6-8-hourly | DPI | |
Salmeterol | 50mcg | 12-hourly | MDI/DPI | |
Formoterol | 12mcg | 12-hourly | MDI/DPI | |
Indacaterol | 150-300mcg | 24-hourly | DPI | |
Anticholinergic (Antimuscarinic) |
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Ipratropium | 42-84mcg | 6-8-hourly | MDI/spacer | |
Tiotropium | 18mcg | 24-hourly | DPI | |
Tiotropium | 2.5mcg | 24-hourly | Respimat | |
Glycopyrronium | 50mcg | 24-hourly | DPI | |
Corticosteroid | Inhaled | |||
Beclometasone (small particle) |
50-200mcg/day | 12-hourly | MDI/spacer | |
Budesonide | 400mcg | 12-hourly | DPI | |
Fluticasone propionate | 250-500mcg/day | 12-hourly | MDI/DPI | |
Fluticasone furoate | 100mcg/day | 12-hourly | DPI | |
Ciclesonide | 80-320mcg/day | 24-hourly | MDI – spacer not recommended | |
MDI=metered dose inhaler. DPI=dry powder inhaler. |
Appendix 2: Explanation of inhaler devices
Delivery system | Available products | Considerations |
Metered dose inhaler (MDI) | Ventolin, Asmol, Airomir, Epaq (salbutamol 100mcg); Atrovent (ipratropium bromide 21mcg); Qvar (beclometasone 50mcg, 100mcg); Alvesco (ciclesonide 80mcg, 160mcg); Flixotide (fluticasone 50mcg, 125mcg, 250mcg); Serevent (salmeterol 25mcg); Seretide (salmeterol 25mcg and fluticasone 50mcg, salmeterol 25mcg and fluticasone 125mcg, salmeterol 25mcg and fluticasone 250mcg); Symbicort Rapihaler (budesonide 200mcg and formoterol 6 mcg) |
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Spacers | Aerochamber Breath-A-Tech Fisonair Nebuhaler Volumatic |
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Autohaler | Airomir (salbutamol 100mcg); Qvar (beclometasone 50mcg, 100mcg) |
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Dry powder inhalers (DPI) |
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Accuhaler | Serevent (salmeterol 50mcg); Flixotide (fluticasone 100mcg, 250mcg, 500mcg); Seretide (salmeterol 50mcg and fluticasone 100mcg, salmeterol 50mcg and fluticasone 250mcg, salmeterol 50mcg and fluticasone 500mcg) |
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Aerolizer | Foradile (formoterol 12mcg) |
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Turbuhaler | Bricanyl (terbutaline 500mcg); Pulmicort (budesonide 100mcg, 200mcg, 400mcg); Oxis (formoterol 6mcg, 12mcg); Symbicort (formoterol 6mcg and budesonide 100mcg , formoterol 6mcg and budesonide 200mcg, formoterol 12mcg and budesonide 400mcg) |
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HandiHaler | Spiriva (tiotropium 18mcg) |
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Breezhaler | Onbrez (indacaterol 150mcg, 300 mcg)
Seebri (glycopyrronium 50mcg) Ultibro (indacaterol 110 mcg/glycopyrronium 50 mcg) |
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Genuair | Bretaris (aclidinium 322 mcg/dose)
Brimica (aclidinium 340 mcg/ formoterol 12 mcg) |
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Ellipta | Breo (fluticasone furoate 100 mcg and vilanterol trifenatate 25 mcg) |
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Soft mist inhaler | Spiriva Respimat (tiotropium 2.5 mcg)
Spiolto Respimat (tiotropium 2.5 mcg/olodaterol 2.5 mcg) |
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Nebulisers | Most nebulisers are electric. Some ultrasonic nebulisers are battery operated. These models are not heavy duty, but are ideal for travelling. There are also 12-volt pumps that plug into a car cigarette lighter. Use of inhaled corticosteroids requires a high-flow, heavy- duty pump. |
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The products listed are not all subsidised under the Pharmaceutical Benefits Scheme for use in COPD. |
Appendix 3: Long term oxygen therapy (McDonald 2016)
Initiating oxygen therapy
- Before introducing oxygen therapy, ensure optimal treatment of the pulmonary disorder while monitoring improvement with objective tests such as FEV1 and forced vital capacity (FVC). Treatment may include maximum therapy for airway obstruction, attention to nutrition and bodyweight, an exercise rehabilitation program, control of infection, and treatment of cor pulmonale.
- In patients selected for oxygen therapy, assess the adequacy of relief of hypoxaemia (PaO2 > 60 mmHg, or 8 kPa; SpO2 > 90%) and/or improvement in exercise capacity or nocturnal arterial oxygen saturation while using a practical oxygen delivery system.
What the patient needs to know
- Patients receiving oxygen therapy in the home, and their carers, should have the use clearly explained. That is, hours of use and flow rate, and any need to vary flow rates at given times. The equipment and its care, including how to obtain servicing or replacements, needs to be explained. The dangers of open flames (especially cigarettes, gas heaters and cookers) need to be emphasised.
- Flow should be set at the lowest rate needed to maintain a resting PaO2 of 60 mmHg (8kPa) or SpO2 > 88%. For patients with COPD, 0.5-2.0 L/min is usually sufficient. Flow rate should be increased by 1 L/min during exercise.
- Humidifiers are generally not needed at oxygen flow rates below 4 L/min.
- Extrasoft nasal prongs are recommended for continuous oxygen use, but may become uncomfortable at flow rates over 2-3 L/min and in the long term. Facemasks may be preferred for at least some of the time, although there are dangers of rebreathing exhaled CO2 at flow rates below 4 L/min.
Review
- Reassess 4-8 weeks after starting continuous or nocturnal oxygen therapy, both clinically and by measurement of PaO2 and PaCO2, with and without supplementary oxygen. A decision can then be made as to whether the treatment has been properly applied and whether it should be continued or abandoned.
- Patients on intermittent oxygen therapy should also be reassessed periodically. The review can be undertaken by appropriately trained staff using a pulse oximeter to confirm hypoxaemia (SpO2 < 88%) at rest or during daily activities. They should also check compliance with therapy and smoking status.
- Review at least annually, or more often according to the clinical situation.
Dangers
- Supplementary oxygen in patients with increased arterial PaCO2 may depress ventilation, increase physiological dead space, and further increase arterial PaCO2. This is suggested by the development of somnolence, headache and disorientation.
- In long-term oxygen therapy, the increase in arterial PaCO2 is usually small and well tolerated. However, serious hypercapnia may occasionally develop, making continued oxygen therapy impractical. Risk appears greater during exacerbations of disease or if the flow of oxygen is increased inappropriately.
- Sedatives (particularly benzodiazepines), narcotics, alcohol and other drugs that impair the central regulation of breathing should not be used in patients with hypercapnia receiving oxygen therapy.
Choosing the right method (see Adult Domiciliary Oxygen therapy Clinical Practice Guideline for further details)
Domiciliary oxygen therapy can be delivered via the following systems:
- Stationary oxygen concentrators: These floor-standing electrically driven devices work by extracting the nitrogen from room air by means of molecular sieves and deliver a continuous flow of oxygen at the outlet. The percentage of oxygen is around 90 to 95% depending on the model used. A back-up standard D-size oxygen cylinder is often supplied in case of concentrator breakdown or power failure. Users may claim a rebate on their electricity account.
- Portable oxygen concentrators: These are small, lightweight portable oxygen concentrators (POC) that are powered by the household electrical supply or via a car battery or rechargeable battery which makes them suitable for ambulatory use. Some models have been approved by some of the commercial airlines. Two types are available, those that are only capable of delivering pulsed oxygen (these are generally smaller and lighter in weight) and those that can deliver both pulsed and continuous flow oxygen. The performance specifications of the different models of POCs vary considerably and for patients with high oxygen needs, some POCs may not achieve a sufficient concentration of inspired oxygen to meet the patient’s needs during exercise.
- Cylinders: These contain compressed oxygen gas and deliver 100% oxygen at the outlet. Portable lightweight cylinders are available. Electronic conservation devices are often supplied to deliver oxygen predominantly during inspiration and therefore avoid wastage. Demand flow devices are the most common and deliver a pre-set volume or bolus of oxygen in early inspiration. Use of such devices results in up to a fourfold reduction in oxygen consumption. Reservoir-style conservers (i.e. nasal cannulae with an integrated pendant shaped reservoir) are a cost-effective alternative.
The prescription should always specify:
- the source of supplemental oxygen;
- method of delivery;
- duration of use; and
- flow rate at rest, during exercise and during sleep.
There is no significant difference in the quality of oxygen delivery among the above methods. However:
- Concentrators are cheaper than cylinders if use is equivalent to or more than three E-size cylinders per month.
- Concentrators can be wheeled around the home but are heavy (about 2126 kg) and are difficult to move up stairs and in and out of cars.
- Concentrators cannot be used for nebulisation, as the pressure delivered is too low (3563 kPa, compared with 140 kPa for nebuliser pumps).
- If the anticipated need is for longer than three years, it is cheaper to buy than to rent a unit. The units usually have a five-year guarantee. However, public funding is available for pensioners and Health Care Card holders, subject to means testing.
Appendix 4 – Strategies that may assist in reminding people to reduce sedentary time
TV viewing | During each advertisement break, stand up and go for a short walk around your house. |
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Reading | At the end of each book chapter or after a few pages of the newspaper, stand up and go for a short walk around your house. |
Transport | Stand up whilst waiting for a bus or train. |
Daily tasks | When ironing, put items away in multiple small trips rather than putting everything away once you have finished. |
Computer use | Consider setting an alarm (e.g. on your phone) to remind you to stand up every 30 minutes. |
Phone use | Consider standing up to use your phone. Go for a short walk around your house after you finish using your phone to call / text someone. |
Appendix 5 – Table of Minimum Clinically Important Differences (MCID) (Cazzola 2015b)
Health status measures
Patient Reported Outcome Measure (PROM) | Purpose | Domains | No. items | Reliability | Validity | MCID |
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St George’s Respiratory Questionnaire (SGRQ) | Assess health status impairment in airways disease(COPD, Asthma, Bronchiectasis) | Symptoms, activity, impacts | 50 | ✔ | ✔ | 4 units |
St George’s Respiratory Questionnaire COPD (SGRQ-C) | Assess health status in COPD – weakest items removed | Symptoms, activity, impacts | 40 | ✔ | ✔ | 4 units |
Chronic Respiratory Questionnaire (CRQ) (short form also available) | Health-related quality of life in chronic respiratory disease | Mastery, fatigue, emotional function and dyspnoea | 20 | ✔ | ✔ | 0.5 units |
Clinical COPD Questionnaire (CCQ) | Health status assessment in a primary care setting | Symptoms, functional state, mental state | 10 | ✔ | ✔ | 0.4 units |
COPD Assessment Test (CAT) | Quantifies symptom burden of COPD, health status measurement | Energy, Sleep, confidence, activities, breathlessness, chest tightness, phlegm, cough | 8 | ✔ | ✔ | 2 units |
Symptom measures
Patient Reported Outcome Measure (PROM) | Purpose | Domains | No. items | Reliability | Validity | MCID |
---|---|---|---|---|---|---|
Modified Medical Research Council (MMRC) | Disability from COPD related to breathlessness | Uni-dimensional | 1 - 5 point scale | ✔ | ✔ | ~ 1, but limited data |
Baseline Dyspnoea Index (BDI) Transitional Dyspnea Index (TDI) | Measurement of dyspnea based on activities of daily living | BDI: functional impairment, magnitude of task, magnitude of effort | BDI 3 TDI 3 | ✔ | ✔ | 1 unit in TDI |
The Breathlessness Cough and Sputum Scale (BCSS) | Tracks severity of resp symptoms and evaluate efficacy in clinical trials - COPD | Breathlessness, cough, sputum | 3 | Acceptable | Acceptable | >1 substantial .6 mod .3 small |
Dyspnoea 12 | Current level of breathlessness severity | Uni-dimensional | 12 | ✔ | ✔ | Not yet established |
Exacerbations
Patient Reported Outcome Measure (PROM) | Purpose | Domains | No. items | Reliability | Validity | MCID |
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The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT®) | Evaluates frequency, severity and duration of an AE COPD (Daily) | Breathlessness, cough and sputum, chest symptoms | 14 | ✔ | ✔ | Not yet established |
Evaluating Respiratory Symptom (E-RS®) | Derivative instrument of the EXACT, designed to address the need for a standardized daily diary to assess respiratory symptoms in patients with stable COPD | Breathlessness, cough and sputum, chest symptoms | 11 | ✔ | ✔ | 3 point Δ(total score) 2 point Δ(breathless-ness) 1 point Δ(cough & sp) 1 point Δ(chest symptoms) |
Appendix 6: Table of Systematic Reviews Evaluating the Effect of Self-Management in COPD
Appendix 6: Table of Systematic Reviews Evaluating the Effect of Self Management in COPD
Authors | Design | Studies included | Participant n= | Aims | Intervention | a. | b. | c. | d. | e. | f. | g. | h. | i. | j. | k. |
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Dickens 2014 | RCT | 32 studies, database inception-2013 | 3941 | To examine the characteristics of complex interventions intended to reduce the use of urgent and unscheduled healthcare among people with COPD | Multiple components and/or professionals, individual, group, phone or computer. Including education, rehabilitation, psychological therapy, social intervention, organisational intervention (e.g. collaborative care or case management), psychological drug trials. Simple interventions, e.g. new treatment for underlying long-term condition, compared to treatment as usual excluded | + | ||||||||||
Majothi 2015 | RCT | 9 studies, Moderate-severe COPD, database inception-2012 | 1466 | To evaluate the effect of COPD self-management following admission to hospital | 1+ components commonly included in self-management interventions, e.g. action plans, exercise, education, inhaler technique, bronchial hygiene and breathing techniques, stress management and relaxation, nutritional programs, patient empowerment, support groups and telecare, provided in hospital or community setting with a usual care, control, sham intervention or other self-management intervention comparator. | + | / | / | / | |||||||
Cannon 2016 | RCT | 25 studies, 1990-2016 | 4082 | To analyse the outcome of self-management RCTs and their impact upon COPD patients' health outcomes using meta-analysis | Self-management intervention including at least 4 of the following: Exacerbation action plan, COPD education, medication information, management of exacerbations, management of stress and/or anxiety, nutritional guidance, exercise program/information, or managing a healthy lifestyle. | + | / | / | + | |||||||
Howcroft 2016 | RCT, quasi RCT | 7 studies, Database inception -2015 | 1550 | Compare COPD exacerbation action plans with a single short educational component + ongoing support directed at use of action plan | Action plan with a single educational component of short duration allowing time for the clinician to personalise plan. Ongoing support delivered by phone or direct contact. Studies with broader self-management support interventions, e.g. education in multiple sessions over a longer period or exercise programmes, with or w/out an action plan were excluded. Active intervention was compared to ’usual care’. | + | / | + | / | + | ||||||
Jolly 2016 | RCT | 173 studies, database inception-2012 | n/a | To identify the most effective components of interventions to facilitate self-management of health care behaviours | Include 3+ components e.g. structured group-based PR programs (to teach self-management skills); educational self-management interventions delivered in an outpatient setting or at home, sometimes with telephone follow-up; integrated disease management with multidisciplinary input and often some element of monitoring by health professionals; exercise-only interventions (with some dyspnoea management) and respiratory muscle training using threshold devices. | + | / | |||||||||
Jonkman 2016 | RCT | 14 studies, 1985-2013 | 3282 | Determine if self-management programs were associated with better outcomes and if any subgroups benefit more | Interventions providing information to patients and including 2+ of: stimulation of sign/symptom monitoring; education in problem solving skills, i.e. self-treatment of acute exacerbations and stress/symptom management; smoking cessation; and stimulation of medical treatment adherence; physical activity; or improving dietary intake. Components aimed at enhancing the patient’s active role and responsibility. | + | + | + | / | |||||||
Lenferink 2017 | RCT | 22 studies, 1995-2017 | 3854 | To evaluate the efficacy of COPD-specific self-management interventions that include an action plan for exacerbations | Must include a written action plan for AECOPD and an iterative process between participant and healthcare provider(s) in which feedback was provided. | + | / | + | / | / | / | - | ||||
Newham 2017 | RCT | 26 RCTs identified from 11 systematic reviews | 3,518 (1,827 intervention, 1,691 control) | To summarize the current evidence base surrounding the effectiveness of self-management interventions for improving HRQOL in people with COPD. | Intervention descriptions were coded for behaviour change techniques (BCTs) that targeted self-management behaviours to address 1) symptoms, 2) physical activity, and 3) mental health. Comparator was usual care. | + | + | |||||||||
Long 2017 | RCT | 10 studies, database inception-August 2018 | 1,959 | To systematically review the evidence for health coaching as an intervention to improve health-related quality of life (HRQoL) and reduce hospital admissions in people with chronic obstructive pulmonary disease (COPD) | Intervention must include evidence of goal setting, motivational interviewing techniques, and COPD-related health education. Interventions that do not have clear evidence of all three components will be excluded. The intervention must be delivered by a qualified HCP, over a minimum of two sessions, either face to face, by telephone, online, email, tablet, smartphone, or a combination of these methods. Interventions that include group, instead of individual, coaching sessions will be excluded. Trials must consist of one group that received the health coaching intervention and one group that received either treatment as usual, wait-list control, or a no intervention control group, | + | / | + | / | |||||||
Jolly 2018 | RCT | 12 studies, database inception-2012 | 10,647 | To evaluate whether self-management intervention sin COPD patients recruited from primary care lead to improved health-related quality of life, improved health outcomes and reduced health care utilisation. | Interventions were heterogeneous by duration (one month to at least 2 years); provider (GPs, nurse practitioners, medical assistants, respiratory physician nurses, health psychologists and trained peers, or a combination); and focus (exacerbation management and responding to participants self-management queries or very comprehensive programmes including information about educational materials, physical activity advice, smoking cessation, breathing and medication management). The control arm of studies was most frequently usual care, with two studies providing information booklets as part of the control arm and one using usual care with an assessment of the patients’ health status every 2 months. | / | / | |||||||||
Aranburu-Imatz 2022 | Systematic review and meta-analysis of observational studies (case–control, cohort and cross-sectional) or intervention study (randomised or non-randomised) | 48 studies met the inclusion criteria for qualitative analysis, of which 25 were considered for meta-analysis, 2009-2021 | 5,215 patients in 48 studies | To analyse the effect of hospital or community nurse-led interventions in the follow-up and management of COPD patients in terms of mental, physical, and clinical status | Nurse-led intervention. Heterogeneity was observed as regards the type of interventions and scope of care. | + | + | + | + | |||||||
Schrijver 2022 | RCTs and cluster RCTs | 27 studies, 1995-2022 | 6,008 | To evaluate the effectiveness of COPD self‐management interventions compared to usual care in terms of health‐related quality of life (HRQoL), respiratory‐related hospital admissions, respiratory‐related mortality and all‐cause mortality. | Self-management interventions compared to usual care. | + | + | / | / | |||||||
+ = improved; /= no change; - = worsened; blank = not measured. 6MWD= 6-minute walk distance, CCT= controlled clinical trials, COPD= chronic obstructive pulmonary disease, ED= emergency department, HRQoL= health-related quality of life, RCT= randomised controlled trial, PR = pulmonary rehabilitation. a. Health-related quality of life (HRQoL); b. All-cause hospitalisations; c. Respiratory-related hospitalisations; d. Mortality; e. emergency department presentations; f. Anxiety & depression; g. Dyspnoea; h. 6-minute walking distance (6MWD); i. Respiratory-related mortality; j. Medication use; k. Urgent healthcare utilisation |