Clinical review protocols

National Clinical Guideline Centre (UK)

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

National Clinical Guideline Centre (UK). Care of Dying Adults in the Last Days of Life. London: National Institute for Health and Care Excellence (NICE); 2015 Dec 16. (NICE Guideline, No. 31.)

Care of Dying Adults in the Last Days of Life.

Show details

Contents

< Prev Next >

Appendix CClinical review protocols

C.1. Recognising Dying

Table 1Review protocol: Recognising dying

Review question	What signs and symptoms indicate that adults are likely to be entering their final days of life; or that they may be recovering? How are uncertainties about either situation dealt with?
Objectives	To determine signs and symptoms of imminent death (that is, in the final days of life), signs and symptoms showing if the patient is recovering, and the uncertainty of the signs and symptoms for predicting imminent death in order to: communicate this to the person and the family communicate this with multi-professional team inform discussions about individual care planning (note link to other qualitative reviews). Recovery objective (to check), or uncertainty of dying as separate objective.
Population	Adults (aged 18 years and over). Exclusions: Children and young people (aged less than 18 years).
Signs/symptoms (for quantitative/pro gnostic component of the review)	Signs and symptoms including in at least one of the following categories (symptom categories as described in Domeisen et al., 2013¹³⁵): Breathing (including rattle and irregular breathing) General deterioration (including extreme weakness) Consciousness/cognition (including reduced cognition) Related to condition of skin (including discolouration) Intake of fluid, food Urine output Emotional state (including anxiety) Social withdrawal Acute – bleeding, renal failure.
Outcomes/themes	Quantitative/prognostic review component: Death (within a few days/hours) (time to event data, if available). Qualitative review component: thematic analysis and presentation of a theoretical framework/conceptual map. Trajectory Patient perspective (if they think they are near death) Resolution with family/relationships).
Study design	Quantitative/prognostic review component: Prospective or retrospective cohorts Qualitative review component: Qualitative review such as large scale or Delphi consensus surveys, interviews Systematic reviews of the above Exclusions: Editorials/commentaries/opinion pieces (other than large consensus surveys).
Exclusions	Non-English language studies Abstracts Papers that focus on transition to palliative care as this is not specific to the final days and hours of life.
Search strategy	The databases to be searched are Medline, Embase, The Cochrane Library, CINAHL, PsychINFO Studies will be restricted to English language only.
Key confounders	Treatments that may suppress conscious level Artificial organ support, such as ventilation
Review strategy	Integrative literature review methods, as used in in Kennedy et al, 2014,²⁵⁷ will be explored. This type of review allows for the inclusion of different study designs (experimental, observational and qualitative) in order to fully understand an area of concern. The review involves both quantitative (prognostic for this review) and qualitative elements. For the quantitative review component: Pooling of individual patient data, if available from the published literature. Pooling of data, if deemed appropriate. Data on the following groups will be presented separately, if the evidence allows: Dementia or other cognitive impairment Learning disabilities Organ system failure (such as heart failure). Subgroups of people: People already diagnosed with a terminal condition Persons with a sudden deterioration of a condition Persons in acute setting without a long-term terminal condition. For the qualitative review component: Thematic analysis and presentation of a theoretical framework/conceptual map.

C.2. Communication

Table 2Review protocol: Communication

Review question	What are the barriers and facilitators to good communication between the dying person, those important to them and the healthcare professional surrounding the likelihood of entering the last days of life?
Objective	To explore the experiences, opinions and attitudes of the dying person and those important to them on the factors that encourage and prevent good communication between them and the healthcare professional when conveying the likelihood they are entering the last days of life. To explore the experiences, opinions and attitudes of the healthcare professional on the factors that encourage and prevent good communication between them and the dying person and those important to them when conveying the likelihood they are entering the last days of life.
Population and setting	Adults who have been recognised as likely to be entering the last days of life, those important to them and healthcare professionals in all settings where NHS funded care is provided.
Context	Context: Communication about the likelihood of entering the last days of life or recovering. Outcomes: Themes will be identified from the literature found. For example: Healthcare professionals level of skills or training. Use of empathy and rapport Time and resource (seniority of staff) Degree of uncertainty Language differences Cultural differences People with cognitive disability People with learning disability Terminology used Timing and place of communication.
Exclusions	None
Search strategy	The databases to be searched are Medline, Embase, The Cochrane Library, CINAHL, PsychINFO Studies will be restricted to English language only.
Review strategy	Study designs to be considered: Qualitative studies (for example, interviews, focus groups, observations) Surveys Review strategy: Population size and directness: No sample size specification (for surveys). Studies with indirect populations will not be considered for example, people who are not entering the last days of life Setting: Any setting where people receive intervention relevant to the NHS. Appraisal of methodological quality The methodological quality of each study will be assessed using NCGC modified NICE checklists and the quality of the evidence will be assessed by a modified GRADE approach for each outcome. Data synthesis Thematic analysis of the data will be conducted and findings presented. If any studies include informationon advance directives we will extract this information for discussion with the Committee. Data on the following groups will be presented separately, if the evidence allows: Dementia or other cognitive impairment Learning disabilities. The recommendations made in CG138 (NICE guideline on ‘Patient experience in adult NHS services’ ³⁴¹ will be taken into consideration where appropriate.

C.3. Shared Decision Making

Table 3Review protocol: Shared decision making

Review question	What are the facilitators and barriers to the multi-professional team, dying person and those important to them in being involved in shared decision making to inform the development of personalised care plans for the last days of life?
Objective	To consider which positive and negative experiences and opinions of the dying person and those important to them to facilitate or hinder the formulation of personalised care plans for the last days of life and how they can be used to improve current practice. To consider which positive and negative experiences and opinions of healthcare professionals could be used to facilitate the active involvement of dying people and those important to them in formulating personalised care plans.
Population and setting	Adults who have been recognised as likely to be entering the last days of life, those important to them and healthcare professionals in all settings where NHS funded care is provide.
Context	Context: Care planning in the last days of life Outcomes: Themes will be identified from the literature. For example: Professional reticence to include dying people in development of personalised care plans. Shared decision making in response to sudden changes Reviewing situation regularly People with cognitive disabilities People with learning difficulties People with communication disorders.
Exclusions	None
Search strategy	The databases to be searched are Medline, Embase, The Cochrane Library, CINAHL, PsychINFO Studies will be restricted to English language only.
Review strategy	Study designs to be considered: Qualitative studies (for example, interviews, focus groups, observations) Surveys. Review strategy: Population size and directness: No sample size specification (for surveys). Studies with indirect populations will not be considered for example, personalised care plans for people who are not in their last days of life. Setting: Any setting where people receive care relevant to NHS care. Appraisal of methodological quality The methodological quality of each study will be assessed using NCGC modified NICE checklists and the quality of the evidence will be assessed by a modified GRADE approach for each outcome. Data synthesis Thematic analysis of the data will be conducted and findings presented. Data on the following groups will be presented separately, if the evidence allows: Dementia or other cognitive impairment Learning disabilities. The recommendations made in CG138 (NICE guideline on ‘Patient experience in adult NHS services’ ³⁴¹ will be taken into consideration where appropriate.

C.4. Maintaining Hydration

Table 4Review protocol: Clinically assisted hydration

Component	Description
Review question	In patients in their last days of life, is clinically assisted hydration effective in improving symptoms and general comfort?
Objectives	To identify whether clinically assisted hydration is effective in the clinical management of a patient in their last days of life.
Population	Adult people in the last days of life who are not maintaining sufficient oral hydration.
Interventions	Clinically assisted hydration Enteral hydration (via nasogastric tube, gastrostomy or jejunostomy) Parenteral hydration (intravenously or subcutaneously).
Comparator	Placebo, for example, clinically insignificant amounts No intervention Oral hydration only.
Outcomes	Critical: Quality of life (either patient-rated, clinician-rated, carer-rated) Symptom improvement on rating scales pre and post intervention. Important: Hydration status using both objective and subjective measures (for example, hydration of oral mucosa, measuring vital signs and skin turgor). Adverse events both procedural (phlebitis, or line infections, for example) and from positive fluid balance (for example, pleural effusions). Subjective ratings from informal carers on quality of care received. Biochemistry results including urea, creatinine and sodium.
Study design	RCT Prospective cohort study Systematic Review Exclusions: Cohort Case series Case reports Narrative summaries (including literature reviews).
Population size and directness	No restrictions.
Setting	All settings.
Search strategy	The databases to be searched are Medline, Embase, The Cochrane Library, CINAHL, PsychINFO Studies will be restricted to English language only.
Review strategy	Appraisal of methodological quality. The methodological quality of each study will be assessed using NICE checklists and the quality of the evidence will be assessed by GRADE for each outcome. Synthesis of data. Meta-analysis will be conducted where appropriate. Data on the following groups will be presented separately, if the evidence allows: Dementia or other cognitive impairment Learning disabilities.

C.5. Pharmacological Interventions

Table 5Review protocol: Pharmacological management of pain, breathlessness, anxiety, agitation and delirium

Component	Description
Review question 6b	For people in the last days of life, which pharmacological agents are most effective in relieving pain, breathlessness, anxiety, agitation and delirium and what degree of sedation do they cause?
Objectives	To identify the most effective pharmacological treatment for pain, breathlessness, anxiety, agitation and delirium in the last days of life.
Population	Adult people in the last days of life.
Interventions	Benzodiazepines lorazepam midazolam diazepam clonazepam Opioids morphine oxycodone fentanyl alfentanil buprenorphine diamorphine Antipsychotics haloperidol levomepromazine olanzapine chlorpromazine Corticosteroids Dexamethasone Prednisolone Diuretics Furosemide Non-steroidal anti-inflammatories ketorolac diclofenac Oxygen Heliox Note: the use of these interventions for palliative sedation is not being considered in this review
Comparison(s)	Any of the above Placebo Usual care
Outcomes	CRITICAL Quality of life or patient wellbeing (as rated by doctor, the dying person or those important to them) Control of specific symptoms (for pain, breathlessness , nausea, vomiting, anxiety, agitation and delirium) IMPORTANT Carer satisfaction Duration of symptom control Length of survival Level of sedation Adverse effects of treatment, including: For antihistamines this may include urinary retention or dizziness. For antipsychotics it may include extrapyramidal side effects, akathisia (restlessness) neuroleptic malignant syndrome, urinary retention and constipation. For Benzodiazepines this may include hypotension respiratory depression or increased restlessness, confusion, ataxia and falls. For opiates it may include respiratory depression, nausea and vomiting, drowsiness, itching dry mouth and constipation. For steroids it may include a change in mental state or gastritis.
Strata	For people with pain with: Drug dependence (illicit or prescribed) Organ failure
	For people with anxiety with: Dementia Mood disorders
	For people with breathlessness with: Heart failure Lung disease
	For people with agitation and/or delirium with: Brain tumour or brain metastases Dementia Metabolic cause of delirium (for example hypercalcaemia, hyponatraemia) Pharmacological causes of delirium including general anaesthesia and sedation on critical care
	People with nausea and vomiting: Bowel obstruction Increased intracranial pressure Metabolic causes Opioid therapy
Subgroups	Drug class Routes of administration Enteral (includes oral and enteral tubes) Intramuscular Intravenous Subcutaneous Transdermal Transmucosal (includes sublingual, buccal, nasal) Delivery system ‘Melt’ tablet Bolus SC injection or continuous SC delivery by syringe driver Continuous IV delivery by pump or Intermittent IV delivery by PCA IM injection Nasogastric tube PEG tube Skin patch Sublingual, buccal, dissolving tablet Tablet, liquid for enteral access
Study design	Systematic reviews of RCTs RCTs Non randomised comparative studies Exclusions: Cohort Case series Case reports Narrative summaries (including literature reviews) Animal studies
Population size and directness	No restrictions.
Setting	All settings.
Search Strategy	The databases to be searched are Medline, Embase, The Cochrane Library, CINAHL, PsychINFO Studies will be restricted to English language only.
Review Strategy	Appraisal of methodological quality: The methodological quality of each study will be assessed using NICE checklists and the quality of the evidence will be assessed by GRADE for each outcome. Synthesis of data: Meta-analysis will be conducted where appropriate. A stepwise approach is suggested: If sufficient randomised evidence is identified, observational studies will not be added If observational studies are considered then studies accounting for confounding factors (multivariable analysis or matching) will be considered next. Only if insufficient randomised or multivariable data is identified will other non- randomised comparative evidence be considered. Data on the following groups will be presented separately, if the evidence allows: Dementia or other cognitive impairment Learning disabilities

Table 6Review protocol: pharmacological management of nausea and vomiting

Component	Description
Review question	For people in the last days of life, which pharmacological agents are most effective in providing relief for nausea and vomiting and what degree of sedation do they cause?
Objectives	To identify the most effective pharmacological treatment for nausea in the last days of life.
Population	Adult people in the last days of life who are nauseous
Comparator	Corticosteroids Dexamethasone Somatostatin analogue antisecretory Octreotide Dopamine receptor blocker Metoclopramide Domperidone Haloperidol Levomepromazine 5-HT3 antagonists Palonosetron Ondansetron Granisetron NK1 antagonists Aprepitant Fosaprepitant Atypical antipsychotics Olanzapine Prochlorperazine Chlorpromazine Antimuscarinic Cyclizine Glycopyrronium Hyoscine butylbromide Hyoscine hydrobromide
Outcomes	Critical: Nausea control (patient-rated, clinician-rated, carer-rated) Number of vomiting episodes Sedation either subjective (patient-rated, clinician-rated, carer-rated) or objective (Glasgow Coma Scale or equivalent scale of responsiveness) Quality of life. Important: Adverse events/withdrawal of the medication due to adverse events Length of survival.
Subgroups	Patients with: Increased intracranial pressure Bowel obstruction Opioid therapy Metabolic causes Routes of administration Enteral (includes oral and enteral tubes) Transmucosal (includes sublingual, buccal, nasal) Subcutaneous Intramuscular Intravenous Transdermal Delivery system Tablet, liquid for enteral access Sublingual, buccal, dissolving tablet ‘Melt’ tablet Nasogastric tube PEG tube Bolus SC injection or continuous SC delivery by syringe driver Continuous IV delivery by pump or intermittent IV delivery by PCA IM injection Skin patch
Study design	Systematic reviews of RCTs RCTs Non-randomised comparative studies Exclusions: Cohort Case series Case reports Narrative summaries (including literature reviews) Animal studies
Population size and directness	No restrictions.
Setting	All settings.
Search Strategy	The databases to be searched are Medline, Embase, The Cochrane Library, CINAHL, PsychINFO Studies will be restricted to English language only.
Review Strategy	Appraisal of methodological quality. The methodological quality of each study will be assessed using NICE checklists and the quality of the evidence will be assessed by GRADE for each outcome. Synthesis of data. Meta-analysis will be conducted where appropriate. A stepwise approach is suggested in the following circumstances: If sufficient randomised evidence is identified; observational studies will not be added. If observational studies are considered then studies accounting for confounding factors (multivariable analysis or matching) will be considered next. Only if insufficient randomised or multivariable data are identified will other non-randomised comparative evidence be considered. Data on the following groups will be presented separately, if the evidence allows: Dementia or other cognitive impairment Learning disabilities

Table 7Review protocol: pharmacological management of respiratory secretions

Component	Description
Review question 6b	For people in the last days of life, which pharmacological agents are most effective in providing relief for troublesome respiratory secretions and what degree of sedation do they cause?
Objectives	To identify the most effective pharmacological treatment for respiratory secretions in the last days of life.
Population	Adults in the last days of life Exclusions: Noisy breathing related to trauma or congenital abnormalities involving the respiratory tract were excluded
Intervention	Anticholinergics Muscarinic acetylcholine receptor antagonist Somatostatin analogue
Comparison(s(	Any of the above Placebo Usual care
Outcomes	CRITICAL Quality of life (either patient-rated, clinician-rated, carer-rated) Sedation (either patient-rated, clinician-rated, carer-rated) Subjective or objective improvement in respiratory secretions (patient-rated, clinician-rated, carer-rated). IMPORTANT Frequency of adverse events - for example Paradoxical agitation, Failure to expectorate, Dry mouth Subjective ratings from informal carers' on distress relating to noisy breathing/respiratory secretions. Subjective ratings from patients' on distress related to noisy breathing/respiratory secretions.
Subgroups	Drug class Routes of administration Enteral (includes oral and enteral tubes) Intramuscular Intravenous Subcutaneous Transdermal Transmucosal (includes sublingual, buccal, nasal). Delivery system ‘Melt’ tablet Bolus SC injection or continuous SC delivery by syringe driver Continuous IV delivery by pump or Intermittent IV delivery by PCA IM injection Nasogastric tube PEG tube Skin patch Sublingual, buccal, dissolving tablet Tablet, liquid for enteral access.
Study design	Systematic reviews of RCTs RCTs Non randomised comparative studies Exclusions: Cohort Case series Case reports Narrative summaries (including literature reviews) Animal studies
Population size and directness	No restrictions.
Setting	All settings.
Search Strategy	The databases to be searched are Medline, Embase, The Cochrane Library, CINAHL, PsychINFO Studies will be restricted to English language only.
Review Strategy	Appraisal of methodological quality: The methodological quality of each study will be assessed using NICE checklists and the quality of the evidence will be assessed by GRADE for each outcome. Synthesis of data: Meta-analysis will be conducted where appropriate. A stepwise approach is suggested: If sufficient randomised evidence is identified, observational studies will not be added If observational studies are considered then studies accounting for confounding factors (multivariable analysis or matching) will be considered next. Only if insufficient randomised or multivariable data are identified will other non-randomised comparative evidence be considered Data on the following groups will be presented separately, if the evidence allows: Dementia or other cognitive impairment Learning disabilities.

C.6. Anticipatory prescribing

Table 8Quantitative review protocol: Anticipatory prescribing

Review question	How effective is anticipatory prescribing at improving comfort in adults in the last days of life compared with prescribing at the bed side?
Population and setting	Adults likely to be entering the last days of life, those important to them and healthcare professionals in all settings where NHS funded care is provided.
Intervention	Anticipatory prescribing of all necessary medications for symptom relief of breathlessness, pain, nausea and vomiting, respiratory secretions, anxiety and agitation available in the home, with sufficient for use over a weekend (plus bank holidays).
Comparison	Usual care (for example prescribing at the bedside).
Exclusions	Drugs outside of end of life symptom management Non-pharmacological treatments Oxygen Studies published prior to 2000.
Outcome	Critical outcomes: Quality of life (as rated by the dying person or those important to them or healthcare professional) Control of specific symptoms (agitation, terminal restlessness, breathlessness, pain, nausea and vomiting, respiratory secretions and anxiety) Important outcomes: Subjective ratings from informal carers on quality of care received. The amount of medication prescribed that is administered. Incidence of prescribed medication misused. Admissions to hospitals for symptom management.
Search strategy	The databases to be searched are Medline, Embase, The Cochrane Library, CINAHL. Studies will be restricted to English language only.
Study design	Systematic reviews of RCTs RCTs Non-randomised comparative studies Exclusions: Cohort Case series Case reports Narrative summaries (including literature reviews)
Population size and directness	No restrictions.
Review Strategy	Appraisal of methodological quality: The methodological quality of each study will be assessed using NICE checklists and the quality of the evidence will be assessed by GRADE for each outcome. Synthesis of data: Meta-analysis will be conducted where appropriate. Data on the following groups will be presented separately, if the evidence allows: Dementia or other cognitive impairment Learning disabilities.

Table 9Qualitative review protocol: Anticipatory prescribing

Review question	What are the experiences, opinions and attitudes of healthcare professionals, the dying person and those important to them regarding access to anticipatory prescribing?
Objective	To explore the experiences, opinions and attitudes of healthcare professionals with regards to who should be responsible for anticipatory prescribing. To explore the experiences, opinions and attitudes of healthcare professionals with regards to when it should be initiated. To explore the experiences, opinions and attitudes of the dying person and those important to them with regards to when it should be initiated.
Population and setting	Adults likely to be entering the last days of life, those important to them and healthcare professionals in all settings where NHS funded care is provided.
Context	Anticipatory prescribing for the last days of life
Exclusions	Drugs outside of end of life symptom management Non-pharmacological interventions Oxygen Studies published prior to 2000
Search strategy	The databases to be searched are Medline, Embase, The Cochrane Library, CINAHL. Studies will be restricted to English language only.
The review strategy	Study designs to be considered: Qualitative studies (for example, interviews, focus groups, observations) Surveys Review strategy: Population size and directness: Sample size specification (for surveys) Studies with indirect populations will not be considered for example., Anticipatory prescribing outside of the last days of life Setting: Any setting where people receive intervention relevant to the NHS Data synthesis Thematic analysis of the data will be conducted and findings presented. Data on the following groups will be presented separately, if the evidence allows: Dementia or other cognitive impairment Learning disabilities.

Bookshelf ID: NBK356020

Contents

< Prev Next >

PubReader
Print View
Cite this Page
National Clinical Guideline Centre (UK). Care of Dying Adults in the Last Days of Life. London: National Institute for Health and Care Excellence (NICE); 2015 Dec 16. (NICE Guideline, No. 31.) Appendix C, Clinical review protocols.
PDF version of this title (3.4M)

Clinical review protocols - Care of Dying Adults in the Last Days of Life
Clinical review protocols - Care of Dying Adults in the Last Days of Life

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

Bookshelf