Adam Garrow

Development and validation of a questionnaire to assess disabling foot pain

Abstract This study outlines the design and validation of a new self‐administered instrument for assessing foot pain and disability. The 19‐item questionnaire was tested on 45 rheumatology patients, 33 patients who had attended their general practitioner with a foot‐related problem and 1000 responders to a population survey of foot disorders. Levels of reported disability were found to be greatest for rheumatology patients and least for community subjects. In addition, the instrument was able to detect differences in disability levels reported by community subjects who did and did not consult with a health care professional and those who did and did not have a history of past and current foot pain. A good level of agreement was found when items on the questionnaire were compared with similar items on the ambulation sub‐scale of the Functional Limitation Profile questionnaire. A Cronbachs alpha value of 0.99 and item‐total correlation values between 0.25 and 0.62 confirmed the internal consistency of the instrument. Finally the results of a principal components analysis identified three constructs that reflected disabilities that are associated with foot pain: functional limitation, pain intensity and personal appearance. The design of the foot disability questionnaire makes it a suitable instrument for assessing the impact of painful foot conditions in both community and clinical populations.

The grading of hallux valgus. The Manchester Scale.

This article describes a new, noninvasive method of assessing the severity of hallux valgus deformity by means of a set of standardized photographs. Six podiatrists were independently asked to grade the level of deformity of 13 subjects (26 feet) on a scale of 1 (no deformity) to 4 (severe deformity). The reliability of the four-point scale for the severity of hallux valgus was investigated by means of kappa-type statistics for more than two raters. The results showed that the grading method had excellent interobserver repeatability with a combined kappa-type statistic of 0.86, making it a suitable instrument for clinical and research purposes.

The Cheshire Foot Pain and Disability Survey: a population survey assessing prevalence and associations.

&NA; Previous foot studies have consistently reported high prevalence estimates in self‐reported foot disorders. Few population studies, however, have attempted to assess the impact of foot problems in terms of pain and disability so that the burden associated with foot pain is unknown. A cross‐sectional postal survey was conducted on a random community sample of 4780 individuals with 3417 (84%) responding. Subjects reporting foot pain in the past month, current pain and marking one item on the Manchester Foot Pain and Disability Index were classified as having disabling foot pain. Those with disabling foot pain and a random sample with no symptoms (matched for age and gender) received a follow‐up interview and standardised foot examination. Self‐reported nail problems, corns and callosities, swollen feet, foot deformities and recent foot injuries were found to be associated with disabling foot pain. Foot disability was also associated with pain in the shoulder, axial skeleton, hip/upper leg and knee along with other indicators of poor general health. Clinician diagnosed foot problems associated with disabling foot pain were swollen feet, knee and foot joint tenderness. Only 36% of persons with disabling foot pain received professional foot treatment in the 6 months preceding the survey. The results showed that 323/3417 (9.5%) reported symptoms of disabling foot pain and that this condition is likely to be multi‐factorial in origin. Further work is necessary to understand more about the extent and type of unmet need and on how patients presenting with symptoms of disabling foot pain should best be managed.

Patient Interpretation of Neuropathy (PIN) Questionnaire: An instrument for assessment of cognitive and emotional factors associated with foot self-care

OBJECTIVE—Using the common-sense model of illness behavior, we developed and validated a self-report instrument for assessment of patients’ cognitive and emotional representations of diabetic peripheral neuropathy (DPN) influencing foot self-care. RESEARCH DESIGN AND METHODS—The Patient Interpretation of Neuropathy (PIN) questionnaire, generated from discussions with clinicians and interviews with patients with DPN, was administered to patients with DPN attending U.K. (n = 325) and U.S. (n = 170) diabetes centers. Psychometric tests of the PIN questionnaire comprised factor analysis, internal consistency, and test-retest reliability. Partial correlations and multivariate regressions established construct and criterion-related validity. The associations of PIN scales to past foot ulceration and foot self-care behaviors were compared with those using a generic measure of illness perception and emotion, the Revised Illness Perception Questionnaire (IPQ-R), which was adapted to neuropathy. RESULTS—Factor analysis of the PIN questionnaire produced 11 scales, which explained 69% of item variance. Nine factors measured patients’ common-sense beliefs about DPN and their levels of understanding of DPN-related medical information. Two factors assessed the emotions of worry about potential consequences and anger at practitioners. Most scales demonstrated adequate internal (Cronbach’s α = 0.62–0.90) and test-retest reliability (Pearson’s r = 0.51–0.64). Partial correlations between the PIN and IPQ-R scales in corresponding domains were significant but modest (rp = 0.15–0.26). Finally, PIN scales showed significant associations with past foot ulceration and foot self-care behaviors, thereby confirming criterion validity. CONCLUSIONS—The 39-item PIN questionnaire is a reliable and valid measure of patients’ cognitive and emotional representations of neuropathy affecting foot self-care.

Vibration perception threshold—a valuable assessment of neural dysfunction in people with diabetes

Diabetic peripheral neuropathy (DPN) has been identified as a key element in the causal pathway to foot ulceration and other lower‐extremity complications, impaired quality of life and increased mortality. Early detection is essential to optimise effective risk management, including adequate foot care, patient education, and future pharmacological therapy. However, data suggest that screening has been mostly sub‐optimal, and many physicians remain unfamiliar with non‐invasive screening tests. There is evidence in the literature to suggest that vibration perception threshold (VPT) measures can be used to easily and accurately identify at‐risk diabetic patients, including those with early neuropathic deficits. These measures have been used in population‐based studies and are associated with an increased risk of severe and expensive outcomes, such as ulcers and amputations. Incorporating VPT testing into clinical practice has the potential to significantly improve the outcomes in patients with DPN, thereby substantially reducing the socio‐economic burden of this common and challenging disease. Copyright

The effectiveness and cost-effectiveness of acupressure for the control and management of chemotherapy-related acute and delayed nausea: Assessment of Nausea in Chemotherapy Research (ANCHoR), a randomised controlled trial

BACKGROUND Chemotherapy-induced nausea and vomiting remain difficult symptoms to manage in clinical practice. As standard antiemetic drugs do not fully eliminate these symptoms, it is important to explore the adjuvant role of non-pharmacological and complementary therapies in antiemetic management approaches. Acupressure is one such treatment showing highly suggestive evidence so far of a positive effect, meriting further investigation. OBJECTIVES The primary objective was to assess the effectiveness and cost-effectiveness of self-acupressure using wristbands compared with sham acupressure wristbands and standard care alone in the management of chemotherapy-induced nausea. Secondary objectives included assessment of the effectiveness and cost-effectiveness of the wristbands in relation to vomiting and quality of life and exploration of any age, gender and emetogenic risk effects. DESIGN Randomised three-arm sham-controlled trial (Assessment of Nausea in Chemotherapy Research or ANCHoR) with an economic evaluation. Arms include the wristband arm, the sham wristband arm and the standard care only arm. Randomisation consisted of minimisation with a random element balancing for gender, age (16-24, > 24-50, >50 years) and three levels of emetogenic chemotherapy (low, moderate and high). Qualitative interviews were incorporated to shed more light on the quantitative findings. SETTING Outpatient chemotherapy clinics in three regions in the UK involving 14 different cancer units/centres. PARTICIPANTS Chemotherapy-naive cancer patients receiving chemotherapy of low, moderate and high emetogenic risk. INTERVENTION The intervention was acupressure wristbands pressing the P6 point (anterior surface of the forearm). MAIN OUTCOME MEASURES The Rhodes Index for Nausea/Vomiting, the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool and the Functional Assessment of Cancer Therapy - General (FACT-G). At baseline participants completed measures of anxiety/depression, nausea/vomiting expectation and expectations from using the wristbands. RESULTS In total, 500 patients were randomised in the study arms (166 standard care, 166 sham acupressure and 168 acupressure) and data were available for 361 participants for the primary outcome. The primary outcome analysis (nausea in cycle 1) revealed no statistically significant differences between the three arms, although the median nausea experience in patients using wristbands (both real and sham ones) was somewhat lower than that in the antiemetics only group (median nausea experience scores for the four cycles: standard care arm 1.43, 1.71, 1.14, 1.14; sham acupressure arm 0.57, 0.71, 0.71, 0.43; acupressure arm 1.00, 0.93, 0.43, 0). A gender effect was evident (p= 0.002), with women responding more favourably to the use of sham acupressure wristbands than men (odds ratio 0.35 for men and 2.02 for women in the sham acupressure group; 1.27 for men and 1.17 for women in the acupressure group). This suggests a placebo effect. No significant differences were detected in relation to vomiting outcomes, anxiety and quality of life. Some transient adverse effects were reported, including tightness in the area of the wristbands, feeling uncomfortable when wearing them and minor swelling in the wristband area (n= 6).There were no statistically significant cost differences associated with the use of real acupressure bands (£70.66 for the acupressure group, £111.13 for the standard care group and £161.92 for the sham acupressure group). In total, 26 subjects took part in qualitative interviews. The qualitative data suggested that participants perceived the wristbands (both real and sham) as effective and helpful in managing their nausea during chemotherapy. CONCLUSIONS There were no statistically significant differences between the three arms in terms of nausea, vomiting and quality of life, although apparent resource use was less in both the real acupressure arm and the sham acupressure arm compared with standard care only; therefore; no clear conclusions can be drawn about the use of acupressure wristbands in the management of chemotherapy-related nausea and vomiting. However, the study provided encouraging evidence in relation to an improved nausea experience and some indications of possible cost savings to warrant further consideration of acupressure both in practice and in further clinical trials. TRIAL REGISTRATION ISRCTN87604299. SOURCE OF FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 26. See the HTA programme website for further project information.

A prospective study of risk factors for foot ulceration: The West of Ireland Diabetes Foot Study

BACKGROUND This is the first study to examine risk factors for diabetic foot ulceration in Irish general practice. AIM To determine the prevalence of established risk factors for foot ulceration in a community-based cohort, and to explore the potential for estimated glomerular filtration rate (eGFR) to act as a novel risk factor. DESIGN A prospective observational study. METHODS Patients with diabetes attending 12 (of 17) invited general practices were invited for foot screening. Validated clinical tests were carried out at baseline to assess for vascular and sensory impairment and foot deformity. Ulcer incidence was ascertained by patient self-report and medical record. Patients were re-assessed 18 months later. RESULTS Of 828 invitees, 563 (68%) attended screening. On examination 23-25% had sensory dysfunction and 18-39% had evidence of vascular impairment. Using the Scottish Intercollegiate Guidelines Network risk stratification system we found the proportion at moderate and high risk of future ulceration to be 25% and 11%, respectively. At follow-up 16/383 patients (4.2%) developed a new foot ulcer (annual incidence rate of 2.6%). We observed an increasing probability of abnormal vascular and sensory test results (pedal pulse palpation, doppler waveform assessment, 10 g monofilament, vibration perception and neuropathy disability score) with declining eGFR levels. We were unable to show an independent association between new ulceration and reduced eGFR [Odds ratio 1.01; P = 0.64]. CONCLUSION Our data show the extent of foot complications in a representative sample of diabetes patients in Ireland. Use of eGFR did not improve identification of patients at risk of foot ulceration.

Role of acupuncture in the management of diabetic painful neuropathy (DPN): a pilot RCT

Aims To examine the role of acupuncture in the treatment of diabetic painful neuropathy (DPN) using a single-blind, placebo-controlled RCT and to collect data that would be required in a future definitive study of the efficacy of acupuncture in DPN. Methods 45 patients were allocated to receive a 10-week course either of real (53%) or sham (47%) acupuncture. Five standardised acupuncture points on the lower limb of each leg were used in the study: LR3, KI3, SP6, SP10 and ST36. Outcome measures included the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale, lower limb pain (Visual Analogue Scale, VAS); Sleep Problem Scale (SPS); Measure Yourself Medical Outcome Profile (MYMOP); 36-item Short Form 36 Health Survey and resting blood pressure (BP). Results Over the 10-week treatment period, small improvements were seen in VAS −15 (−26 to −3.5), MYMOP −0.89 (−1.4 to −0.3), SPS −2.5 (−4.2 to −0.82) and resting diastolic BP −5.2 (−10.4 to −0.14) in the true acupuncture group. In contrast, there was little change in those receiving sham acupuncture. A moderate treatment effect in favour of active acupuncture was detected in MYMOP scores −0.66 (−0.96 to −0.35) but non-significant effect sizes in LANSS Pain Scale −0.37 (−2.2 to 1.4), resting diastolic BP −0.50 (−3.0 to 1.99) and the SPS −0.51 (−2.2 to 1.16). Conclusions We have demonstrated the practicality and feasibility of acupuncture as an additional treatment for people with DPN. The treatment was well tolerated with no appreciable side effects. Larger randomised trials are needed to confirm the clinical and cost-effectiveness of acupuncture in the treatment of DPN. Trial Registration Number ISRCTN number: 39740785.

The development and first validation of the Manchester Early Morning Symptoms Index (MEMSI) for patients with COPD

Aim Early morning symptoms (EMS) in people with COPD are associated with poor health, impaired activities and increased exacerbation risk. We describe the development and preliminary validation of the Manchester Early Morning Symptom Index (MEMSI) to quantify EMS in COPD. Methods Focus groups and cognitive debriefing with patients with COPD were used to develop the potential item list, followed by a cross-sectional study to finalise the items for inclusion. In addition to test-retest reliability, comparisons with the St Georges Respiratory Questionnaire-C (SGRQ-C), modified Medical Research Council Dyspnoea Scale, Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) and Hospital Anxiety and Depression Scale (HADS) evaluated construct validity. Hierarchical methods informed item deletion and Rasch analysis was applied to assess scale unidimensionality. Results 23 items were identified from the focus groups and debriefings. The cross-sectional study involved 203 patients with COPD (mean age 64.7 SD 7.5 years, male 63%, Global Initiative for Chronic Obstructive Lung Disease (GOLD): 1:14% 2:41% 3:25% 4: 7%). 13 items were removed during item reduction. MEMSI contains 10 items, demonstrates good overall fit to the Rasch model (χ2 p=0.26) and item score distribution; excellent reliability (Person Separation Index: 0.91) and good test-retest repeatability (r=0.82). It correlates with the SGRQ-C (r=0.73), FACIT-F (r=−0.65) and HADS (r=0.53–0.54) indicating good construct validity. Conclusions MEMSI is a reliable and valid unidimensional measure of EMS for patients with COPD. It is simple to use and score supporting its suitability for research and clinical use. Work is underway to determine the minimal clinical important difference and cross-cultural validity.

Systematic literature review of patient-reported outcome measures used in assessment and measurement of sleep disorders in chronic obstructive pulmonary disease.

Background Sleep problems are common in patients with chronic obstructive pulmonary disease (COPD), but the validity of patient-reported outcome measures (PROMs) that measure sleep dysfunction has not been evaluated. We have reviewed the literature to identify disease-specific and non-disease-specific sleep PROMs that have been validated for use in COPD patients. The review also examined the psychometric properties of identified sleep outcome measures and extracted point and variability estimates of sleep instruments used in COPD studies. Methods The online EMBASE, MEDLINE, PsycINFO, and SCOPUS databases for all years to May 2014 were used to source articles for the review. The review was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Criteria from the Medical Outcomes Trust Scientific Advisory Committee guidelines were used to evaluate the psychometric properties of all sleep PROMs identified. Results One COPD-specific and six non-COPD-specific sleep outcome measures were identified and 44 papers met the review selection criteria. We only identified one instrument, the COPD and Asthma Sleep Impact Scale, which was developed specifically for use in COPD populations. Ninety percent of the identified studies used one of two non-disease-specific sleep scales, ie, the Pittsburgh Sleep Quality Index and/or the Epworth Sleep Scale, although neither has been tested for reliability or validity in people with COPD. Conclusion The results highlight a need for existing non-disease-specific instruments to be validated in COPD populations and also a need for new disease-specific measures to assess the impact of sleep problems in COPD.