Template Service Evaluation Plan
for the Pharmacological Management of Pain
1. Background
Improving the quality and outcomes of health care and services is a priority for NHS
commissioners, managers, practitioners and service users1. In order to demonstrate quality
and value, it is important to evaluate normal clinical practice. Furthermore the route to
delivering and ensuring service improvement is through the evaluation of current and new
services.
Evaluation of the use of medicines in the early stage of uptake may be a local requirement of
the Trust or CCG and may be a prerequisite for formulary approval. Assessments of the
effectiveness of medicines in clinical practice have also been used to justify their continued
or expanded use.
Projects to evaluate the use of treatments used in normal clinical practice (i.e not subject to
allocation or randomisation) to inform local decision making rather than derive generalizable
new knowledge are regarded by the National Research Ethics Service as part of NHS quality
assurance rather than research2. Furthermore if the objective of such projects is to define or
evaluate current care without reference to a predetermined standard they are defined as
‘Service Evaluations’ rather than ‘Audits’.
Each year over 5 million people in the United Kingdom develop chronic pain3. Chronic pain
reduces quality of life more than almost any other condition. If pain is not adequately
controlled, it may result in increased costs of analgesia and unnecessary and avoidable
visits to GPs, outpatient referrals, attendance at A&E and emergency admissions4.
Early intervention with appropriate pain management may not only reduce the level of pain,
but may also reduce the number of steps a patient takes within an individual pathway and
reduce the overall cost of NHS resources.
2. Aim
To measure standard of care, through evaluation of the effectiveness of a selected analgesic
used in routine clinical practice, in order to support and inform local decision making.
3. Objectives
To describe the baseline demographic and disease characteristics of patients receiving a
selected analgesic in routine clinical practice, including: Age, gender, diagnosis, duration & intensity of symptoms, extent of painful area
(topical treatment), health related quality of life (HR-QoL), prior analgesia, prior
consultations, non-pharmacological therapy, concomitant medication
To evaluate the effectiveness and acceptability of a selected analgesic in routine clinical
practice, including: Pain intensity, pain relief, extent of painful area (topical treatment), HR-QoL,
treatment satisfaction, effect on sleep, effect on mood, co-analgesia, discontinuation,
consultations, non-pharmacological therapy, concomitant medication
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4. Intervention
Separate template data collection forms have been devised to support the evaluation of
either a topical analgesic (Appendix 1) or an oral strong analgesic (Appendix 2) for the
management of chronic pain and are intended to be suitable for use with all such treatments.
The analgesic to be evaluated is ………………………………………………………………
[To be completed by HCP undertaking the service evaluation]
5. Methods
The baseline evaluation of demographic and disease characteristics should be completed at
the time the patient is prescribed the selected analgesic, prior to administering the first dose.
The baseline evaluation should be completed by the clinician in consultation with the patient.
One or more follow-up evaluations of the effectiveness and acceptability of the selected
analgesic should be performed. The frequency and interval between assessments should be
defined with consideration to the specific local objective(s) of the service evaluation; the
available resource to support the evaluation and the local practice for clinical review of such
patients. Any assessment of initial effectiveness of a pain treatment should be performed a
minimum of 2 weeks and ideally 4 weeks after commencing treatment. Longer term
assessments of effectiveness are typically performed with a frequency of 3 or 6 months from
the baseline / previous visit.
The follow-up evaluation(s) can be completed by the patient, however for completeness and
consistency of data collection it is desirable for the evaluation to be reviewed at the time of
completion by the clinician. The follow-up evaluation could be emailed or posted to the
patient with a request for them to return the completed evaluation form to the surgery/clinic.
However not all patients will complete and return the evaluation correctly and consideration
should be given to the impact of the response rate on the robustness of the service
evaluation.
The follow-up evaluation will be performed after ……………. weeks / months of treatment.
A subsequent follow-up evaluation(s) will occur ……………. months after starting treatment.
The total number of evaluations per patient is ……………..
[To be completed by HCP undertaking the service evaluation]
6. Patient Selection
Service evaluations are non-interventional. Therefore the decision to treat a patient and the
choice of therapy should be taken in accordance with local clinical practice before any
consideration of their inclusion in this evaluation.
In order to obtain an unbiased estimate of its effectiveness ideally all patients commencing
treatment with the selected analgesic during the evaluation period should be included.
To provide reassurance and ensure engagement it is advisable to explain the nature and
objectives of the project to the patient, including: The fact that the patient is not involved in the clinical research of a new medication
but an evaluation of how the selected analgesic they have been prescribed works in
routine clinical practice
 The timing of follow-up evaluation(s)
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
The fact that no one other than those normally authorised to do so will have access
the patient’s medical records or identifiable patient data
7. Assessments
Data will be collected by means of a questionnaire. Assessments are restricted to those
which may be collected as part of routine care, in order to minimise burden or intrusion to
patients. Questions on the effectiveness and acceptability of the selected analgesic should
be answered by the patient without any assistance from the clinician. Depending on local
clinical practice, data to be collected may include:a. Baseline Evaluation
Demographic Information
 Date of birth
 Gender
Disease Information
 Diagnosis
 Date of diagnosis
Medication History
 Prior pain therapy
 On-going pain therapy (co-analgesia)
 Concomitant medication (other conditions)
Non-pharmacological therapy
 Cold, heat, massage, acupuncture, relaxation, TENs, other
Symptoms
 Date of onset of pain
 Area of pain (topical treatment)
 Pain type (oral treatment)
o Nociceptive, Neuropathic, Mixed, unknown
 Average severity of pain over the last 7 days
o NRS – 11 point numerical rating scale; 0 = no pain – 10 = worst pain
imaginable
 Symptom relief
o NRS – 11 point % rating scale; 0% = no pain relief – 100% = complete pain
relief
Health Related Quality of Life
 EQ-5D & EQ-VAS
o The EuroQol - 5 dimension quality of life index (EQ-5D) assesses health
status for each of five dimensions (mobility, self-care, usual activities,
pain/discomfort, anxiety/depression). Responses to the five dimensions are
collectively expressed as an EQ-5D score using the value set which ranges
from 1 for full health (no problem in any dimension) to -0.594 for severe
problems in all five dimensions. The UK EQ-5D value set has been obtained
using a representative sample of the general population, thereby ensuring
that they represent the societal perspective
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o
The EQ VAS records the respondent’s self-rated health on a visual analogue
scale where the endpoints are labelled ‘Best imaginable health state’ and
‘Worst imaginable health state’. This information can be used as a
quantitative measure of health outcome as judged by the individual
respondents
Resource utilisation
 Number of pain related consultations in the last 3 months with:o GP, Hospital Doctor, Practice / District Nurse, Hospital Nurse, other
 Number of pain related attendances in the last 3 months with:o Community based pain clinic, A&E Department, Hospital pain clinic
 Number of pharmacist reviews in the last 3 months
b. Follow-up evaluation
In addition to the information collected at baseline:Discontinuation (if appropriate)
 Date, reason
Dose of selected analgesic
 Number of plasters / frequency of application, area applied (topical treatment)
 Daily dose (oral treatment)
Satisfaction with selected analgesic
 NRS – 11 point % rating scale; 0% = Extremely dissatisfied – 100% = Extremely
satisfied
Effect of selected analgesia on sleep, mood
 Better? Yes, No, Unsure
8. Sample size and Statistical Considerations
This is an observational evaluation of patients prescribed the selected analgesic in routine
clinical practice. Such evaluations do not include a pre-defined hypothesis to be tested.
Therefore it is not appropriate to perform a power calculation to define the size of sample of
patients to be included. The sample size will depend on the rate of prescribing of the
selected analgesic and the time period over which the evaluation is performed.
The number of patients included and the duration of the evaluation should be defined with
consideration to the specific local objective(s) of the service evaluation and the available
resource to support its completion. Anecdotally all patients prescribed the selected analgesic
over a 3-6 month period, involving 20-50 patients, have typically been considered adequate
to inform local decision making.
The anticipated duration of recruitment of patients is ……………. months.
The anticipated number of patients included in the evaluation is ……………..
[To be completed by HCP undertaking the service evaluation]
Analyses should be descriptive in nature. Distributions and descriptive statistics of both
central tendency (means, medians) and dispersion (standard deviation, range or interquartile
range) may be presented for quantitative variables. Nominal variables may be described with
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frequencies, percentages and modes, while ordinal variables may have medians and
ranges.
9. Data Management and Confidentiality of Patient Data
The data collection forms may be retained and analysed by the evaluating clinician.
Alternatively, clinicians seeking support with the analysis and reporting of the collected data
may utilise a secure online data entry and reporting portal provided by Pharmatelligence.
Pharmatelligence are a Clinical Data Capture and Health Research Consultancy based at
the Cardiff Medicentre, University Hospital Wales with close links with Cardiff University,
where a number of employees have joint appointments. Pharmatelligence provides support
for electronic data capture and analysis of health-related data to academia, the NHS, and
the pharmaceutical industry.
The data is pseudonymised by the assignment of an identification number to each patient.
The link between the identification number and unique patient identifiers, such as the
patient’s name, NHS number etc., will remain confidential to the clinician undertaking the
evaluation.
Pseudonymised data for each patient is entered by NHS personnel directly involved with the
evaluation into a unique, secure database. Data analysis and reporting is performed using
MS Excel and can only be accessed via the secure, password protected portal. Thus
information concerning the identity of patients remains confidential and is not disclosed
outside of the evaluation site.
Data capture, data processing and data storage at Pharmatelligence conforms to all
recognised international standards.
Analysis and reporting will be performed locally
Analysis and reporting will utilise the secure online portal
10. Regulatory, Ethical and Governance Considerations
Service evaluations are observational (non-interventional) and therefore exempt from
compliance with the EU Clinical Trials directive and can be conducted without applying to the
MHRA for a Clinical Trials Authorisation (CTA)5.
Projects to evaluate the use of treatments used in normal clinical practice (i.e. not subject to
allocation or randomisation) to inform local decision making rather than derive generalizable
new knowledge are regarded by the National Research Ethics Service as part of NHS quality
assurance rather than research. Such projects do not require research ethics committee
(REC) review2.
Whilst not regarded as research and therefore not subject to management within the
Research Governance Framework for Health and Social Care, your local NHS research and
development (R&D) office will be able to advise on any local governance procedures for this
type of project. These might include, for example, authorisation and oversight by a clinical
effectiveness manager or a senior person in the department / unit in which the evaluation is
based. It is the responsibility of the clinician undertaking the service evaluation to establish
whether this is the case in their locality.
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Use of the secure online data entry and reporting portal will require approval to release data
from your Trust (including anonymised or coded data). This can usually be obtained from the
Trust Data Protection Officer (Caldicott Guardian) via the R&D department. Data Protection
Officers must satisfy themselves that the data are to be released for a legitimate purpose
and that there is either valid patient consent for the data release, or the data are adequately
anonymised so that no patient can be identified by anyone outside the Trust. It is the
responsibility of the clinician undertaking the service evaluation to obtain this approval if the
online data entry facility is used.
The requirements of the Data Protection Act 1998, when applied to research mean that
patient consent must also be obtained for access of researchers to identifiable medical
records for the purposes of research, whether interventional or non-interventional. However,
a specific research exemption allows clinicians to access their own patients’ records for
research, without obtaining patient consent to use the record for a different purpose than that
which it was created (that purpose being clinical care of the patient). Non-clinical
researchers do not have the right to access patients’ records without specific consent but
anonymised data can be supplied by clinicians to researchers without patient consent6.
11. Pharmacovigilance requirements
Adverse events should be reported. Reporting forms and information can be found at
www.yellowcard.mhra.gov.uk/
Please report all suspected ADRs to drugs marked with an inverted black triangle (▼) (ie
new drugs on the market).
For established drugs report all suspected adverse reactions that you consider to be serious.
They should be reported even if the effect is well recognised.
Serious reactions are those which are:
 fatal
 life-threatening
 disabling
 incapacitating
 have resulted in, or prolonged, hospitalisation
 medically significant
 congenital abnormalities
12.
Data ownership
The service evaluation tools are provided as a medical service by Grünenthal Ltd to support
the local evaluation of the effectiveness of a selected analgesic used in routine clinical
practice, in order to support and inform local decision making. Ownership of all data,
analyses and reports generated through the use of these tools will remain with the NHS
institution undertaking the service evaluation. Grünenthal will not have access to any data,
analyses or reports generated through the use of these tools.
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13.
References
The NHS White Paper “Equity and Excellence: Liberating the NHS”
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213823/dh_117794.pdf
(accessed 08/08/13)
1
2
National Research Ethics Service. Defining Research
http://www.nres.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=355 (accessed 08/08/13)
3
Donaldson L. Annual Report of the Chief Medical Officer. London: Department of Health: 2008. p33–
39
4
Langley P, et al. The societal impact of pain in the European Union: health-related quality of life and
healthcare resource utilization. J. Med. Econ. 2010; 13(3): 571–581
5
Is it a clinical trial of a medicinal product? (accessed 08/08/13)
http://www.mhra.gov.uk/home/groups/l-unit1/documents/websiteresources/con009394.pdf
6
Demonstrating value with Real World data: A Practical Guide. ABPI 2011 (accessed 08/08/13)
http://www.abpi.org.uk/our-work/library/guidelines/Documents/2011-0512%20ABPI%20guidance%20-%20Demonstrating%20value%20with%20real%20world%20data.pdf
Appendix 1
Template Data Collection Forms of a Topical Analgesic
Appendix 2
Template Data Collection Forms of an Oral Strong Analgesic
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