Chapter 2 Literature Review
2.7 Conclusion
3.2.13 Data collection and study instruments
3.2.13.2 Participant clinical data
Baseline data were collected from participants before initiating the intervention and are
presented in Table 3.4. Socio-demographic data included participant’s age, sex, employment and nationality. Medical and surgical history included chronic leg ulcer type (venous, arterial, mixed, incompressible or diabetic), duration (weeks), surface area (cm2) and ankle brachial pressure index (ABPI) in addition to screening for 23 comorbidities. Data on medications such as opiates,
non-steroidal anti-inflammatory drugs (NSAIDs), other pain medications, antihypertensive, anticoagulant, antibiotic medications and nicotine were also collected.
Participant clinical data relating to wound-related pain, wound healing and HRQoL were
collected at baseline and throughout the study. Outcome assessment time points are presented in Table 3.5 and data collection instruments used, outcome measures, estimated time of
completion, psychometric properties and rationale for their use are presented in Table 3.6.
Table 3.4 Baseline measurements Participant history Wound-related pain HRQoL relating to CLU CLU Characteristics - Socio- demographic history; - Medical and surgical history - WRP at dressing change - - Before - During - After; - Pain type; - Quality; - Location; - Pain medications; - Effects on activities - Social life; - Wellbeing; - Physical symptoms; - Overall HRQoL
- Leg ulcer surface area;
- Aetiology and duration of leg ulcer; - Ankle Brachial Pressure Index; - Leg ulcer measurement:
- Exudate type and amount - Necrotic tissue type and amount - Granulation type and amount - Condition of wound edges - Peri ulcer viability
- Oedema type and location - Assessment of bioburden - Wound-related pain intensity
and frequency assessment over previous 24 hours
- How HRQoL relates to the leg ulcer
Abbreviations: WRP, wound-related pain; CLU, chronic leg ulcer; HRQoL, health-related
Ankle Brachial Pressure Index and Lower Limb Risk Assessment tool
An ABPI, in conjunction with clinical assessment data using a Lower Limb Risk Assessment Tool (Appendix 10 and 11), was collected on each participant. This information assists the clinician to classify the leg ulcer type before the implementation of any management options (AustralianWound Management Association Inc and New Zealand Wound Care Society, 2011; Templeton & Telford, 2010; Vowden & Vowden, 2001) and is standard practice in the Central Coast Community Nursing Service. An ABPI is a non-invasive measure to determine large vessel peripheral arterial disease in the lower limb before application of compression therapy. The accuracy of the leg ulcer diagnosis is enhanced by the combination of both the ABPI and clinical assessment (AustralianWound Management Association Inc and New Zealand Wound Care Society, 2011). A Dopplex MD2 bi-directional Doppler with high sensitivity wide beam EZ8 or 5MHz probe (ArgoHuntleigh, Macquarie Park, NSW, Australia) was used to assess ABPIs in this study.
Ankle Brachial Pressure Indexes were obtained following randomisation unless the participant had vascular studies performed within the previous 6 months which were reviewed by a vascular surgeon. In these instances, ABPI reports were requisitioned from the vascular surgeons for review and data collection.
Table 3.5 Outcome assessment time points
Measure Baseline Week 2 Week 4 Week 8 Week 12
WRP intensity ✓ At every dressing change
WRP over past 24 hours ✓ At every dressing change
When pain felt at home Whenever pain perceived at home
CLU size ✓ ✓ ✓ ✓ ✓
CLU appearance and progress
✓ ✓ ✓ ✓ ✓
HRQoL ✓ ✓ ✓ ✓ ✓
Abbreviations: WRP, wound-related pain; CLU, Chronic leg ulcer; HRQoL, Health-related
Table 3.6 Data collection instruments used, their outcome measures, estimated time of completion, psychometric properties, rational for their use
Data collection instrument Outcome measure Estimated
time of completion
Psychometric properties Rationale
Wound-related pain at dressing change monitoring and
evaluation tool (World Union of
Wound Healing Societies, 2007) (Appendix 12)
Includes: -11-point NRS;
- Provision to record and monitor any intervention;
- Data recorded by treating clinician
Wound-related pain intensity: the higher the score, the higher the WRP.
1 minute NRS - discriminative power relating to chronic pain. Test, re-test reliability high (r = 0.96);
Construct validity - highly correlated with the VAS for chronic pain conditions (reported range: 0.86 to 0.95) (Hawker, Mian, Kendzerska, & French, 2011)
To determine the effectiveness of the intervention on WRP intensity. A reliable and valid pain assessment tool that has high compliance rates and superior responsiveness (Ferreira-Valente, Pais- Ribeiro, & Jensen, 2011; Hjermstad et al., 2011)
Wound-related pain at dressing change assessment tool (World
Union of Wound Healing Societies, 2007) (Appendix 13)
The tool was completed by participants unless physically impaired or burdened
Wound-related pain response to
intervention over the previous 24 hours, included: WRP timing, location, quality, medications
5 minutes - Data collection tool not validated however its development was informed with multidisciplinary input and incorporated
recommendations from the WUWHS; it was
- To capture the multidimensional aspects of the participant’s overall WRP
experience over the previous 24 hours after application of the intervention;
- Enables early identification of the participant’s WRP at dressing change so effective strategies may be implemented if
and effects on sleep and activities of daily living
subsequently endorsed by the WUWHS in 2008 (World Union of Wound Healing Societies, 2004)
necessary. It is practical, quick and easy to use
American Geriatric Society Pain Diary (American Geriatric Society
Panel on Persistent Pain in Older Persons, 2002) (Appendix 14) - Diaries were completed by participants in their home;
- Completed diaries were returned weekly in a sealed opaque
envelope to the chief investigator/RA
WRP intensity; - The frequency of the consumption of pain- relieving medications
Less than 5 minutes
Data collection tool not validated however pain diaries are considered ‘valid and reliable measures of pain severity and activity’ (p. S23) and based on real-time rather than recall particularly in clinical trials and community settings (Hadjistavropoulos et al., 2007(Dansie & Turk, 2013))
- To identify factors that intensified or reduced pain and strategies used to alleviate pain;
- The tool was developed specifically for older individuals with persistent pain and recommended by an international
multidisciplinary expert panel for researchers and clinicians
(Hadjistavropoulos et al., 2007); - Limitations - non-adherence,
considerable participant burden, recall bias and issues with current pain as an anchor for retrospective reporting (Dansie & Turk, 2013; Hadjistavropoulos et al., 2007)
Wound photography and Chronic leg ulcer 15 minutes Inter-rater reliability and - This technique avoids direct contact with
2-dimensional photo-digital planimetry measurement over time (cm2) including download
intra-rater reliability are higher than traditional wound
the wound and is quick and user friendly; - An objective measurement of wound - All wounds were digitally onto a tracing methods (94% and healing was obtained and a photographic photographed using specific wound computer for 98.3% respectively record was able to be retained and use for
photography specifications (Appendix 15);
- Wound measurements were performed by a health service aid and an enrolled nurse who were blinded to the participant’s group assignment; definitive
measurement was by a Nurse Practitioner - wound management who was not blinded. An example of digital photography and
planimetry in ICIS is presented in Figure 3.2
measurement (Wendelken et al., 2011) subsequent assessment
Leg Ulcer Measurement Tool
(Woodbury, Houghton, Campbell, & Keast, 2004) - clinical and patient domains
(Appendix 16).
- Comprises 14 clinician and 3 patient-rated domains;
- Each domain has 5 ordered response categories coded 0 to 4; the sum of the clinician-rated and
- Exudate type and amount;
- Wound surface area, depth and
undermining; - Necrotic tissue type
and amount; - Granulation type
and amount;
- Wound edge status.
Up to 10 minutes
Concurrent construct validity high (r = 0.82) with excellent intrarater/interrater reliability for the total LUMT scores (ICC >0.75) and for many of the 14 domains. Some domains were less
reproducible (Woodbury et al., 2004)
Specifically designed for clinical or research use on CLUs to quantify assessment over time and recommended by the World Health Organisation (MacDonald & Gryer, 2010)
patient-rated domains are totalled to ascertain overall leg ulcer assessment over time;
- A reduction in scores over time indicates an improvement of the CLU
- Periulcer skin viability;
- Leg oedema type and amount; - Assessment of bioburden; - Amount of WRP; - Frequency of WRP; - HRQoL relating to the CLU
Cardiff Wound Impact Schedule HRQoL while 5 to 10 The CWIS has good internal -The CWIS can discriminate between
(CWIS) (Price & Harding, 2004) experiencing WRP; minutes consistency reliability health states (healed vs non-healed
(Appendix 17). - Participants ability to (Cronbach’s α = 0.77 - 0.96), wounds);
Consists of 47 items across 4 socialise; and a high level of - Is sensitive enough to distinguish subscales – - Participants well- reproducibility (p = <0.001) between experiences of a wound from
- 3 subscales use 5-point Likert being regarding the other factors present in this patient
scale: Social life, Well-being and wound and anxiety population;
Physical symptoms and Daily about the wound - A validated condition-specific measure
Living; outcome; questionnaire to assess the HRQoL in
These subscales are changed onto a - The impact of participants with chronic wounds of the
0-100 scale using a formula symptoms on comfort lower limb irrespective of the ulcer
provided by the developers of the and daily functioning aetiology (Jaksa & Mahoney, 2010; Price
- Overall HRQoL consists of 2 questions using an 11-point Likert scale - How good is your quality of life? and How satisfied are you with your overall quality of life? - For all subscales, a high score signifies a positive rating
- Overall HRQoL - Has been validated linguistically for
translation into French, German, US English and Swedish (Acquadro, Price, & Wollina, 2005; Fagerdahl, Bostrom, Ulfvarson, Bergstrom, & Ottosson, 2014), which would be a benefit for use in future international multisite trials;
- Disease-specific HRQoL tools support the importance of pain for people with chronic leg ulcers and also highlight the impact of sleep disturbance, exudate, malodour, and social isolation on HRQoL however, as with generic tools, these tools also exhibit variations in the degree of sensitivity to changes in ulcer status (Green & Jester, 2010)
Abbreviations: WRP, wound-related pain; CLU, chronic leg ulcer; HRQoL, health-related quality of life; NRS, Numerical Rating Scale; WUWHS,
World Union of Wound Healing Societies; ICIS, Integrated Community Information System; RA, research assistant; LUMT, Leg Ulcer Management Tool; ICC, intraclass correlation coefficient; r, correlation coefficient.
Figure 3.2 Example of digital photography and planimetry in Integrated
Community Information System
In this study, self-report questionnaires were used to capture data on wound-related pain and HRQoL. Self-report methods are robust regarding adaptability and directness and frequently yield information from participants that can be difficult to gather using other methods (Polit & Beck, 2017). Despite these advantages, self-reports have their weaknesses. The most serious weakness is the validity and accuracy of self-reports. Individuals can distort the data resulting in random measurement error and systematic bias particularly if respondents have an imperfect recall or deliberately give misleading answers (Polit & Beck, 2017; van de Mortel, 2008). The investigators were cognisant of the limitations of this method when interpreting the results.