Transcutaneous electrical nerve stimulation for cancer pain in adults.

Background Cancer-related pain is complex and multi-dimensional but the mainstay of cancer pain management has predominately used a biomedical approach. There is a need for non-pharmacological and innovative approaches. Transcutaneous Electric Nerve Stimulation (TENS) may have a role for a significant number of patients but the effectiveness of TENS is currently unknown. Objectives The aim of this systematic review was to determine the effectiveness of TENS for cancer-related pain in adults. Search strategy We searched The Cochrane Library, MEDLINE, EMBASE, CINAHL, PsychINFO, AMED and PEDRO databases (11/04/08). Selection criteria Only randomised controlled trials (RCTS) investigating the use of TENS for the management of cancer-related pain in adults were included. Data collection and analysis The search strategy identified 37 possible published studies which were divided between two pairs of review authors that decided on study selection. A study eligibility form was used to screen each abstract and where study eligibility could not be determined from the abstract, the full paper was obtained and assessed by one pair of review authors. A standardised data extraction sheet was used to collect information on the studies and the quality of the studies was assessed independently by two review authors using the validated five-point Oxford Quality Scale. Final scores were discussed and agreed between all four review authors. The small sample sizes and differences in patient study populations of the two included studies prevented meta-analysis. Main results Only two RCTs met the eligibility criteria (64 participants). These studies were heterogenous with respect to study population, sample size, study design, methodological quality, mode of TENS, treatment duration, method of administration and outcome measures used. In one RCT, there were no significant differences between TENS and placebo in women with chronic pain secondary to breast cancer treatment. In the other RCT, there were no significant differences between acupuncture-type TENS and sham in palliative care patients; this study was underpowered. Authors' conclusions The results of this systematic review are inconclusive due to a lack of suitable RCTs. Large multi-centre RCTs are required to assess the value of TENS in the management of cancer-related pain in adults

Clinically important differences in the intensity of chronic refractory breathlessness

Context: Clinically important differences in chronic refractory breathlessness are ill defined but important in clinical practice and trial design. Objectives: To estimate the clinical relevance of differences in breathlessness intensity using distribution and patient anchor methods. Methods: This was a retrospective data analysis from 213 datasets from four clinical trials for refractory breathlessness. Linear regression was used to explore the relationship between study effect size and change in breathlessness score (0-100 mm visual analogue scale) and to estimate the change in score equivalent to small, moderate, and large effect sizes. Pooled individual blinded patient preference data from three randomized controlled trials were analyzed. The difference between the mean change in Day 4 minus baseline scores between preferred and non-preferred arms was calculated. Results: There was a strong relationship between change in score and effect size (P = 0.001; R 2 = 0.98). Values for small, moderate, and large effects were -5.5, -11.3, and -18.2 mm. The participant preference change in score was -9 mm (95% CI, -15.8, -2.1) (P = 0.008). Conclusion: This larger dataset supports a clinically important difference of 10 mm. Studies should be powered to detect this difference

Blinded patient preference for morphine compared to placebo in the setting of chronic refractory breathlessness – an exploratory study

Context Patients’ preference for morphine therapy has received little attention in the setting of chronic refractory breathlessness. However, this is one important factor in considering longer term therapy. Objectives The aim of this secondary analysis is to explore blinded patient preference of morphine compared to placebo for this indication and to define any predictors of preference. Methods Data were pooled from three randomized, double-blind, crossover, placebo-controlled studies of morphine (four days each) in chronic refractory breathlessness. Blinded patient preferences were chosen at the end of each study. A multivariable regression model was used to establish patient predictors of preference. Results Sixty-five participants provided sufficient data (60 males; median age 74 years; heart failure 55%, chronic obstructive pulmonary disease 45%; median Eastern Cooperative Oncology Group performance status 2). Forty-three percent of participants preferred morphine (32% placebo and 25% no preference). Morphine preference and younger age were strongly associated: odds ratio = 0.85, 95% confidence interval 0.78, 0.93;

Minimally clinically important difference in chronic breathlessness: every little helps

ObjectivesThe aim of the study was to determine the minimally clinically important difference (MCID) for breathlessness due to chronic heart failure (CHF). BackgroundThe measurement of breathlessness is difficult because it is subjective and multifactorial. Statistically significant changes in assessment may not be clinically meaningful. This is the first determination of MCID in chronic breathlessness in CHF using patient-rated data. MethodsMeasurements were made as part of a randomized, controlled, crossover trial of morphine, oxycodone, or placebo for breathlessness in CHF. Breathlessness intensity was assessed at baseline and at the end of each intervention (day 4) using 11-point numerical rating scales (NRS), modified Borg (mBorg) scales, and global impression of change (GC) in breathlessness at day 4. From these data, the change in NRS or mBorg associated with a 1-point change in GC was calculated. ResultsThirty-five patients completed all study interventions, resulting in 105 data sets. We defined MCID as a 1-point change in GC. Regression analysis found that the MCID, including 95% CIs, equaled change in average NRS breathlessness per 24 hours of 0.5 to 2.0 U (P < .001), change in worst NRS breathlessness per 24 hours of 0.4 to 2.9 (P < .001), change in average mBorg score of 0.2 to 2.0 (P < .001), and change in worst mBorg score as between 0.3 and 1.9 (P < .001). Corresponding effect size calculations lay within the 95% CIs for the regression analysis for each measure

Short-term opioids for breathlessness in stable chronic heart failure: A randomized controlled trial

Aims To assess the effect of oral opioids vs. placebo on breathlessness in patients with chronic heart failure (CHF). Methods and results Oral morphine (Oramorph), oral oxycodone (Oxynorm), and placebo were studied in an outpatient setting. Once randomized, participants received all three interventions in a controlled double-blind crossover trial for 4 days each, with a 3-day washout between interventions. Patients known to the Hull and East Yorkshire Academic Cardiology department with CHF (New York Heart Association Grade III–IV) were invited to participate. Participants were eligible if they were on standard medical therapy with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, and diuretics. Participant-rated change in 11-point numerical rating scale (NRS) (average over previous 24 h) breathlessness severity score from baseline (Day 1) to Day 4 of treatment was the primary outcome measure. The study was powered to detect a one-point change in severity.Thirty-nine patients were randomized and 35 completed all three study arms. Breathlessness severity was reduced from baseline with all three interventions. There was no statistically significant difference between active intervention and placebo or between the two types of opioid for the primary endpoint [-1.37 in NRS score for placebo group vs. -0.41 in morphine group (P = 0.13) and -1.29 for oxycodone group (P = 0.90)]. The response to treatment was not affected by aetiology, severity of CHF, or concurrent drug therapy. Opioid administration did not cause detrimental changes in clinical observations and was well tolerated. Conclusion We demonstrated no benefit over placebo for the relief of breathlessness with short-term low-dose oral opioids for CHF patients

A Cochrane systematic review of transcutaneous electrical nerve stimulation for cancer pain.

Cancer-related pain is complex and multi-dimensional; yet, the mainstay of cancer pain management has been the biomedical approach. There is a need for nonpharmacological and innovative pain management strategies. Transcutaneous electrical nerve stimulation (TENS) may have a role. The aim of this systematic review was to determine the effectiveness of TENS for cancer-related pain in adults. The Cochrane Library, MEDLINE, EMBASE, CINAHL, PsychINFO, AMED, and PEDro databases were searched for randomized controlled trials (RCTs) investigating the use of TENS for the management of cancer-related pain in adults. Once relevant studies were identified, two pairs of reviewers assessed eligibility for inclusion in the review based on a study eligibility form and using the 5-point Oxford Quality Scale. Two RCTs met the study eligibility criteria (these involved 64 patients). These studies were heterogeneous with respect to study population, methodology, and outcome measures. This prevented meta-analysis. In one RCT, there were no significant differences between TENS and placebo in women with chronic pain secondary to breast cancer treatment. In the other RCT, there were no significant differences between acupuncture-like TENS (AL-TENS) and sham in palliative care patients; this study was significantly underpowered. There is insufficient available evidence to determine the effectiveness of TENS in treating cancer-related pain. Further research is needed to help guide clinical practice, and large multi-center RCTs are required to assess the value of TENS in the management of cancer-related pain in adults

The relationship between two performance scales : New York Heart Association Classification and Karnofsky Performance Status Scale

Context: Performance status is used to quantify the well-being and functional status of people with illness. Clinicians and researchers from differing fields may not instinctively understand the scales, typically disease specific, used in other disciplines. Objectives: To provide a preliminary description of the relationship between the Karnofsky Performance Status Scale (KPS) and the New York Heart Association Classification (NYHA) and to stimulate discussion in research and clinical practice. Methods: Simultaneous KPS and NYHA data (172 observations) from three studies of people with chronic heart failure were pooled. Linear regression was used to predict the mean KPS from NYHA. The strength of association between the scales was investigated using a Kendall's Tau-b correlation coefficient. The agreement between the predicted and observed KPS scores was investigated using weighted kappa with quadratic weights. Results: Linear regression demonstrated a relationship between KPS and NYHA (P < 0.0001; R2 = 0.3). Predicted KPS from NYHA class rounded to the nearest 10 gave the following values: Class I, predicted KPS 90%; Class II, predicted KPS 80%; Class III, predicted KPS 70%; and Class IV, predicted KPS 60%. A moderate strength of association between KPS and NYHA (Kendall's Tau-b correlation coefficient of -0.49; P < 0.0001) and agreement between observed and predicted KPS (kappa coefficient = 0.52) was shown. Conclusion: We suggest that the NYHA discriminates poorly between clinically important performance states in people with advanced disease (NYHA III and IV; KPS <50%). The KPS, used in conjunction, would provide useful additional information in research and clinical practice

Measurement of breathlessness in clinical trials in patients with chronic heart failure: the need for a standardized approach: a systematic review

AIMS: Chronic breathlessness is a major symptom for patients with compensated chronic heart failure (CHF) and its impact is different to the breathlessness resulting from pulmonary oedema. This systematic review aims to establish which tools have been used for research into the subjective severity of breathlessness in patients with compensated CHF and to discuss recommendations for the future. METHODS AND RESULTS: Medline (1950-2008), Embase (1980-2008), Cinahl (1982-2008), and Cochrane databases were searched for clinical studies in patients with compensated CHF including a subjective measure of breathlessness severity as an outcome measure. A total of 322 studies were found of which 41 were retrieved and 26 studies met the review criteria. Few studies had severity of breathlessness as a primary endpoint. Nineteen used a uni-dimensional tool including visual analogue, Borg or Likert scales, either alone, or as a subscale of a quality of life measure. Five used the CHF questionnaire. Two papers used the Baseline Dyspnoea Index-Transitional Dyspnoea Index (BDI-TDI). CONCLUSION: Despite breathlessness being an important and limiting problem for patients with CHF, we found no consensus on which tool should be used for breathlessness severity, little methodological research to develop such a tool, and a lack of focus on breathlessness as a symptom. A consistent approach to studying breathlessness in patients with CHF is needed in order to make headway in managing this key patient priorit