Measuring Health: A Guide to Rating Scales and Questionnaires

Background
This is an updated version of the original Cochrane review published in Issue 12, 2011. Phantom limb pain (PLP) is pain that arises in the missing limb after amputation and can be severe, intractable, and disabling. Various medications have been studied in the treatment of phantom pain. There is currently uncertainty in the optimal pharmacologic management of PLP.

Objectives
This review aimed to summarise the evidence of effectiveness of pharmacologic interventions in treating PLP.

Search methods
For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL, the Cochrane Library), MEDLINE, and Embase for relevant studies. We ran the searches for the original review in September 2011 and subsequent searches for this update up to April 2016. We sought additional studies from clinical trials databases and reference lists of retrieved papers.

Selection criteria
We included randomised and quasi-randomised trials studying the effectiveness of pharmacologic interventions compared with placebo, another active treatment, or no treatment, in established PLP. We considered the following outcomes: change in pain intensity, function, sleep, depression or mood, quality of life, adverse events, treatment satisfaction, and withdrawals from the study.

Data collection and analysis
We independently assessed issues of study quality and extracted efficacy and adverse event data. Due to the wide variability in the studies, we did not perform a meta-analysis for all the interventions and outcomes, but attempted to pool the results of some studies where possible. We prepared a qualitative description and narrative summary of results. We assessed clinical heterogeneity by making qualitative comparisons of the populations, interventions, outcomes/outcome measures, and methods.

Main results
We added only one new study with 14 participants to this updated review. We included a 14 studies (10 with low risk of bias and 4 with unclear risk of bias overall) with a total of 269 participants. We added another drug class, botulinum neurotoxins (BoNTs), in particular botulinum toxin A (BoNT/A), to the group of medications reviewed previously. Our primary outcome was change in pain intensity. Most studies did not report our secondary outcomes of sleep, depression or mood, quality of life, treatment satisfaction, or withdrawals from the study.

BoNT/A did not improve phantom limb pain intensity during the six months of follow-up compared with lidocaine/methylprednisolone.

Compared with placebo, morphine (oral and intravenous) was effective in decreasing pain intensity in the short term with reported adverse events being constipation, sedation, tiredness, dizziness, sweating, voiding difficulty, vertigo, itching, and respiratory problems.

The N-methyl D-aspartate (NMDA) receptor antagonists ketamine (versus placebo; versus calcitonin) and dextromethorphan (versus placebo), but not memantine, had analgesic effects. The adverse events of ketamine were more serious than placebo and calcitonin and included loss of consciousness, sedation, hallucinations, hearing and position impairment, and insobriety.

The results for gabapentin in terms of pain relief were conflicting, but combining the results favoured treatment group (gabapentin) over control group (placebo) (mean difference -1.16, 95% confidence interval -1.94 to -0.38; 2 studies). However, gabapentin did not improve function, depression score, or sleep quality. Adverse events experienced were somnolence, dizziness, headache, and nausea.

Compared with an active control benztropine mesylate, amitriptyline was not effective in PLP, with dry mouth and dizziness as the most frequent adverse events based on one study.

The findings for calcitonin (versus placebo; versus ketamine) and local anaesthetics (versus placebo) were variable. Adverse events of calcitonin were headache, vertigo, drowsiness, nausea, vomiting, and hot and cold flushes. Most of the studies were limited by their small sample sizes.

Authors' conclusions
Since the last version of this review, we identified another study that added another form of medical therapy, BoNTs, specifically BoNT/A, to the list of pharmacologic interventions being reviewed for clinical efficacy in phantom limb pain. However, the results of this study did not substantially change the main conclusions. The short- and long-term effectiveness of BoNT/A, opioids, NMDA receptor antagonists, anticonvulsants, antidepressants, calcitonins, and local anaesthetics for clinically relevant outcomes including pain, function, mood, sleep, quality of life, treatment satisfaction, and adverse events remain unclear. Based on a small study, BoNT/A (versus lidocaine/methylprednisolone) does not decrease phantom limb pain. Morphine, gabapentin, and ketamine demonstrate favourable short-term analgesic efficacy compared with placebo. Memantine and amitriptyline may not be effective for PLP. However, results must be interpreted with caution, as they were based mostly on a small number of studies with limited sample sizes that varied considerably and also lacked long-term efficacy and safety outcomes. The direction of efficacy of calcitonin, local anaesthetics, and dextromethorphan needs further clarification. Overall, the efficacy evidence for the reviewed medications is thus far inconclusive. Larger and more rigorous randomised controlled trials are needed for us to reach more definitive conclusions about which medications would be useful for clinical practice.

Pharmacologic interventions for treating phantom limb pain.

This paper presents a gait phase detection algorithm for providing feedback in walking with a robotic prosthesis. The algorithm utilizes the output signals of a wearable wireless sensory system incorporating sensorized shoe insoles and inertial measurement units attached to body segments. The principle of detecting transitions between gait phases is based on heuristic threshold rules, dividing a steady-state walking stride into four phases. For the evaluation of the algorithm, experiments with three amputees, walking with the robotic prosthesis and wearable sensors, were performed. Results show a high rate of successful detection for all four phases (the average success rate across all subjects >90%). A comparison of the proposed method to an off-line trained algorithm using hidden Markov models reveals a similar performance achieved without the need for learning dataset acquisition and previous model training.

https://www.mdpi.com/1424-8220/14/2/2776/pdf

Online Phase Detection Using Wearable Sensors for Walking with a Robotic Prosthesis

While rituximab has dramatically improved outcomes for patients with CD20+ malignancies for two decades, responses are not universal and resistance can develop. Obinutuzumab was developed to potentiate activity and overcome resistance. Pre-clinical data suggests obinutuzumab is superior to rituximab at effecting B cell depletion; however recent phase III clinical trial results have been mixed. The decision of which antibody to employ will probably be further complicated by the approval of a subcutaneous preparation of rituximab and several anti-CD20 biosimilars. Clinicians are now challenged with deciding whether to switch to obinutuzumab in approved settings, accepting the potential for increased toxicity and probable increased cost. The benefit conferred by obinutuzumab over rituximab may be context-specific and vary based on histological subtype and immune integrity. This comprehensive review will explore the preclinical differences, investigate the proposed pathogenesis of rituximab resistance, compare the employed dosing strategies and interrogate available clinical results to help inform practice.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bjh.15232

A tale of two antibodies: obinutuzumab versus rituximab

BACKGROUND Postamputation pain affects a large number of individuals living with major limb loss. Regenerative peripheral nerve interfaces are constructs composed of a transected peripheral nerve implanted into an autologous free muscle graft. The authors have previously shown that regenerative peripheral nerve interfaces can be used to treat symptomatic end neuromas that develop after major limb amputation. In this study, they investigated the potential of prophylactic interfaces to prevent the formation of symptomatic neuromas and mitigate phantom limb pain. METHODS Patients who underwent limb amputation with and without prophylactic regenerative peripheral nerve interface implantation were identified. A retrospective review was performed to ascertain patient demographics, level of amputation, and postoperative complications. Documentation of symptomatic neuromas and phantom limb pain was noted. RESULTS Postoperative outcomes were evaluated in a total of 90 patients. Forty-five patients underwent interface implantation at the time of primary amputation, and 45 control patients underwent amputation without interfaces. Six control patients (13.3 percent) developed symptomatic neuromas in the postoperative period compared with zero (0.0 percent) in the prophylactic interface group (p = 0.026). Twenty-three interface patients (51.1 percent) reported phantom limb pain, compared with 41 control patients (91.1 percent; p < 0.0001). CONCLUSIONS Prophylactic regenerative peripheral nerve interfaces in major limb amputees resulted in a lower incidence of both symptomatic neuromas and phantom limb pain compared with control patients undergoing amputation without regenerative peripheral nerve interfaces, suggesting that prevention of peripheral neuromas following amputation may diminish the central pain mechanisms that lead to phantom limb pain. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, III.

Prophylactic Regenerative Peripheral Nerve Interfaces to Prevent Postamputation Pain.

Background: Quality of life (QoL) is increasingly being recognized as an important outcome for rehabilitation programs, and has mainly been used to compare the efficacy of interventions or to compare amputees with other diseased populations. There is relatively a limited number of studies primarily focusing on analyzing the multitude of factors influencing QoL in amputees.Objectives: To identify important background and amputation related factors which affect quality of life (QoL) in lower limb amputees, and to compare QoL profile of amputees’ to that of general population.Study design: Cross-sectional.Methods: Lower limb amputees 18 years and above from a rehabilitation centre, a limb-fitting centre and four limb-fitting camps were interviewed (n = 605). Structured questionnaires included patient background and amputation characteristics, and the MOS short-form health survey (SF-36) for assessing QoL. The SF-36 was administered to a general adult population using purposive sampling (n = 184).Results: SF-...

https://poi.sagepub.com/content/35/1/90.full.pdf

Factors affecting quality of life in lower limb amputees

Purpose. To systematically review studies on quality of life (QoL) in lower limb amputees.Method. Computerised literature search of MEDLINE, CINAHL, PUBMED and PsycINFO databases was performed using the keywords, amputee, leg, knee, foot, amputation, QoL, prosthesis, orthopaedic equipment, ADL, phantom, mobility, rehabilitation, psychosocial, psychology and social. Eligible studies published from database inception through March 2009 were selected. The study was included if (1) the study population comprised of adolescent and adult lower-limb amputees as a group or a sub-group, and had ten or more subjects; (2) the study involved subjective assessment of QoL or self-appraisal of life or satisfaction with life; (3) the study was an empirical research study and (4) at least one of the study outcomes was QoL or self-appreciation of life, and QoL results were presented. The selected articles were assessed for study quality based on a standardised set of 19 criteria. The criteria list was pilot-tested for appl...

A systematic literature review of quality of life in lower limb amputees

Background: Health is defined as the state of complete physical, mental and social well-being than just the absence of disease or infirmity. In order to measure health in the community, a reliable and validated instrument is required. Objectives: To adapt and translate the Medical Outcomes Study Short-Form Health Survey (SF-36) for use in India, to study its validity and reliability and to explore its higher order factor structure. Materials and Methods: Face-to-face interviews were conducted in 184 adult subjects by two trained interviewers. Statistical analyses for establishing item-level validity, scale-level validity and reliability and tests of known group comparison were performed. The higher order factor structure was investigated using principal component analysis with varimax rotation. Results: The questionnaire was well understood by the respondents. Item-level validity was established using tests of item internal consistency, equality of item-scale correlations and item-discriminant validity. Tests of scale-level validity and reliability performed well as all the scales met the required internal consistency criteria. Tests of known group comparison discriminated well across groups differing in socio-demographic and clinical variables. The higher order factor structure was found to comprise of two factors, with factor loadings being similar to those observed in other Asian countries. Conclusion: The item-and scale-level statistical analyses supported the validity and reliability of SF-36 for use in India.

Validity and Reliability of MOS Short Form Health Survey (SF-36) for Use in India.

Background:Positive adjustments to amputation and an artificial limb play important roles in the rehabilitation processObjectives:To study the different facets of adjustments to amputation and an artificial limb in lower limb amputees and to assess the possible role of different background and amputation-related factors that could potentially influence these adjustmentsStudy design:Cross-sectionalMethods:Adult unilateral and non-congenital lower limb amputees (n = 368) met the inclusion/exclusion criteria Face-to-face interviews were conducted using structured questionnaires including patient’s background, amputation and the Trinity Amputation and Prosthesis Experience ScalesResults:Amputees were on average satisfied with the functioning of the prosthesis, moderately psychosocially adjusted and not restricted in performing functional and social activities, except for athletic activities Age, employment, daily use of prosthesis and assistive device use were the most important factors associated with 

https://poi.sagepub.com/content/38/2/115.full.pdf

Adjustments to amputation and an artificial limb in lower limb amputees.

The objectives of this study are to investigate the relationship between adjustments to amputation and artificial limb, and quality of life (QoL), and to analyse the influence of sociodemographic, medical and amputation-related factors on this relationship. Patients with unilateral and noncongenital lower limb amputation who were using artificial limb were interviewed (n=368) using structured questionnaires. The Trinity Amputation and Prosthesis Experience Scales (TAPES) were used to assess adjustments to amputation and artificial limb and the MOS Short-Form Health Survey (SF-36) was used to assess the physical (PCS) and mental (MCS) component summary of QoL. Absence of comorbidity and residual stump pain, being employed, young age, less functional restriction, being more adjusted to limitation, increased social adjustment and less restriction in athletic activity were related to better PCS scores. Absence of comorbidity and phantom limb pain, nonuse of assistive device, being more adjusted to limitation, increased social adjustment and being less functionally restricted were related to higher MCS scores. Comorbidity had a modifying effect on both PCS and MCS scores. In addition, age, being employed and residual stump pain had a modifying influence on PCS, whereas assistive device use and phantom limb pain had a modifying influence on MCS. Our findings show that TAPES subscales have a modifying effect on the associations between several background (sociodemographic and amputation characteristics) and QoL (PCS and MCS). This indicates that adjustments to amputation and artificial limb are the key determinants of QoL in individuals following lower limb amputation.

Richa Sinha

Papers

Factors affecting quality of life in lower limb amputees

A systematic literature review of quality of life in lower limb amputees

Validity and Reliability of MOS Short Form Health Survey (SF-36) for Use in India.

Adjustments to amputation and an artificial limb in lower limb amputees.

Influence of adjustments to amputation and artificial limb on quality of life in patients following lower limb amputation