Defining patient-based minimal clinically important effect sizes: a study in palliative radiotherapy for painful unresectable pelvic recurrences from rectal cancer.

PURPOSE: To measure patient-based minimal clinically important effect sizes (minimal incremental benefit that an individual would require to accept one treatment option over another) for pain relief between two contrasting palliative radiotherapy regimens for painful pelvic recurrences from rectal cancer. METHODS AND MATERIALS: Forty-three patients with a history of cancer pain without prior pelvic radiotherapy participated in decision aid-facilitated trade-off exercises. The clinical scenario and treatment options of a 5-day vs. a 20-day course of radiotherapy were described. The duration of pain relief for the 20-day regimen was increased until the respondents' preferences switched to the 20-day regimen. The exercises were repeated for different probabilities of benefit and pain intensity at the time of decision making. RESULTS: When the probability of pain relief was unchanged, the median switch point for the duration of pain relief was 6.7 and 7.2 months for severe and mild pain, respectively. The cumulative percentage frequency curve for the switch points approximated a sigmoid distribution. CONCLUSION: Determining the minimal clinically important effect sizes for symptom relief for palliative therapies is feasible. This type of information can be used to incorporate patient values into clinical trial designs. Modification of this method can be used to improve our understanding of shared (physician and patient) decision making.

Effective bone palliation as related to various treatment regimens.

Various dose-time treatment plans have been used to obtain long duration pain relief in patients with metastatic bone disease. Very little has appeared in the literature evaluating the relationship of dose and fractionation to initial, delayed and permanent bone pain relief. At the Swedish Hospital Tumor Institute, 152 treatment fields in 110 patients were evaluated, with a clinical follow-up in many of over five years. Those treated at lower total doses with less fractionation achieved the same quality and duration of pain relief as higher doses. Treatment plans also were compared using the Ellis method of nominal standard dose.

Deriving dichotomous outcome measures from continuous data in randomised controlled trials of analgesics.

Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices, rather than using discontinuous events--such as number or proportion of patients with 50% pain relief. Because mean data inadequately describe information with a non-normal distribution, combining mean data in systematic reviews may compromise the results. Showing that dichotomous data can reliably be derived from mean data, at least in acute pain models, indicates that more meaningful overviews or meta-analysis may be possible. This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data, and then used that relationship to derive dichotomous from continuous information in randomised controlled trials (RCTs) of analgesics. Individual patient information from 13 RCTs of parallel-group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score (%maxTOTPAR) and the proportion of patients with greater than 50% pain relief (> 50%maxTOTPAR) for the different treatments. The relationship between the measures was investigated in 45 actual treatments and 10,000 treatments simulated using the underlying actual distribution; 1283 patients had 45 separate treatments. Mean %maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR (r2 = 0.90). The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50% pain relief in 42 of 45 treatments, and 98.8% of 10,000 simulated treatments. For seven effective treatments, actual numbers-needed-to-treat (NNT) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data.

"Why haven't you taken any pain killers?" A patient focused study of the walking wounded in an urban emergency department.

OBJECTIVES: (1) To assess the proportion of patients of triage category 3-5 presenting to the minor side of an urban emergency department who present without taking prior pain relief, and (2) to describe the reasons why they do not take pain relief for their presenting complaint METHOD: By patient interview of a convenience sample of 60 adult patients in the setting of an urban emergency department. RESULTS: Fifteen of 60 patients had taken analgesia and 45 of 60 (75%) had not. Sixteen reasons were volunteered to the interviewer. Most patients offered one reason only 39 of 45 (87%). The three commonest single reasons cited for not taking pain relief were "don't like taking tablets" 10 (22%), "run out of tablets" 10 (22%), five (11%) said their "pain not bad enough". Six (13%) patients cited two reasons for not taking pain relief. Only three (6%) patients indicated that they "did not think about pain relief". Six (13%) of patients had inappropriate perceptions of how pain killers may interfere with their care. CONCLUSION: Most patients presenting with painful conditions to the minor side of an urban emergency department had not taken pain relief. The study highlights there are many different reasons for this and staff should not presume that it was because the patient "did not think about it". Ongoing education of staff and patients is needed.

pain relief during delivery by transcutaneous electrical nerve stimulation.

The degree of pain alleviation achieved by transcutaneous electrical nerve stimulation (TNS) during delivery has been evaluated. The usual technique of TNS was modified to suit the requirements of pain relief during delivery. Two pairs of electrodes were taped on the parturient's back at levels TH10--L1 and S2--S4. These segments correspond to the pathway of pain afferents into the spinal cord during the first and second stages, respectively. Stimulation was delivered by a two-channel generator producing biphasic pulses which were variable in frequency and amplitude. A low-intensity stimulation was given continuously and a high-intensity stimulation could be initiated by the parturient herself whenever pain increased. Stimulation was provided via the thoracic electrodes throughout the delivery, whereas sacral stimulation was added from the later part of the first stage. No complications with respect to mother or child have occurred. One hundred and forty-seven women have been treated, 65 (44%) of whom considered the pain relief by TNS to be good to very good, 65 (44%) experienced moderate effect, while 17 (12%) women considered that TNS was without effect. In view of the relatively good results and since no complications have occurred, we consider the method recommendable as a primary pain relieving measure to which conventional methods can be added according to need.

An appraisal of the ethical issues involved in high-technology cancer pain relief.

...We will turn our attention to the current state of pain relief technology and the ethical questions surrounding the use of advanced technology, otherwise referred to as "high-tech," pain relief. It is obvious that pain may decrease the quality of life for cancer patients. The availability of long-acting narcotics, such as MS Contin or methadone, affords cancer patients long-duration pain relief at minimal cost. The use of adjuvant medications may also be important. Clinical examples of the effective use of adjuvant medications include the addition of a nonsteroidal, anti-inflammatory agent to help patients cope with bone pain and the use of a serotonin blocking agent to reduce the transmission of pain impulses in the spinal cord. Only a small percentage of patients are good candidates for high-tech delivery systems for narcotic administration. In our pain management clinic, all patients are initially placed on oral medications. When the side effects of oral medications become excessive, or the patient becomes unable to take oral medications, high-tech modalities are considered for use.

Egg membrane as a new biological dressing in split-thickness skin graft donor sites: a preliminary clinical evaluation.

BACKGROUND: This preliminary investigation attempted to determine the effectiveness of egg membranes as a new biological dressing to promote infection-free healing and provide pain relief over split-thickness skin graft (STSG) donor sites. METHODS: Eighteen patients, with 28 STSG donor sites who were admitted to the LinKou Burn Center from August 1997 to July 1999, were selected for this trial. The bilateral thighs were the main donor sites for STSG. To compare different dressings, Surgilon, B.G.C. (beta-glucan collagen), and Biobrane were applied to the same donor sites, and epithelialization, pain relief, fluid accumulation, hematoma formation, and the occurrence of rejection or infection were monitored post-application. RESULTS: The average wound healing time with egg membrane application was 11.64 +/- 1.29 (range, 10 to 13) days. Meanwhile, the average wound healing times for B.G.C. (6 patients) and Biobrane (6 patients) were 14.5 +/- 0.84 and 14.0 +/- 0.63 days, respectively. Finally, Surgilon (16 patients) had the longest healing time, at 16 +/- 1.41 days. On average, complete pain relief was achieved by 7.3 +/- 0.70 days for egg membrane application, while for B.G.C., Biobrane, and Surgilon, complete pain relief occurred by 7.0 +/- 0.89, 6.0 +/- 0.63, and 10.0 +/- 0.37 days, respectively. Finally, no infection or rejection developed during healing. CONCLUSIONS: From this preliminary study, egg membrane may be an ideal STSG donor site dressing, as it possesses properties of pain relief, wound protection, promotion of healing, and low cost. However, the limited unit size must be overcome, and its clinical application for burn wounds should be studied.

Shaping attitudes to postoperative pain relief: the role of the acute pain team.

Postoperative pain relief is often inadequate. Ignorance and misconceptions about opioids by ward staff contribute to this poor management. The introduction of acute pain teams has done much to improve pain relief for patients. It may also have contributed to changes in attitudes and knowledge of medical and nursing staff. We questioned 48 doctors and nurses on their knowledge and beliefs about postoperative pain relief. Staff members were questioned on two units, one with access to an acute pain team and one without. Over half those on the unit using traditional postoperative care thought patients did not receive adequate pain relief (58%). In comparison, only one respondent from the unit with the pain team thought this was the case (P < 0.001). More staff members that had experience of patient-controlled analgesia (PCA) were optimistic about its benefits than those in the unit with no experience; they were also less concerned about possible side effects. Only one respondent on the unit using PCA thought it carried a risk of drug dependence, compared to over half (55%) of those on the unit with no experience in this technique (P < 0.001). Over two-thirds of staff familiar with PCA thought nursing workload had decreased. Acute pain teams have an important role in educating ward staff. The impact of establishing such teams on staff knowledge and attitudes needs further study to ensure that they can carry out this role most effectively.

Sickle cell anemia day hospital: an approach for the management of uncomplicated painful crises.

Painful crisis episodes are poorly treated in sickle cell anemia, both in timeliness and appropriateness of care. Delayed treatment in Emergency Departments, unrelieved pain, frequent admissions, and prolonged hospitalizations are common. We established a Day Hospital (DH) to determine if an alternative care delivery system could improve pain relief and reduce unnecessary hospital admissions for patients with uncomplicated painful crises. Trained DH staff delivered prompt titration for pain relief based on each patient's analgesic history and qualitative and quantitative assessments. Response to therapy and comorbidities commanded disposition. During the first 5 years of DH operation there were 2554 visits; 60% of the patients had severe pain. During an average visit of 4.5 hours, 84% of the patients were titrated to relief; 90% had pain relief within 2 to 4 hours. Overall, 81% of the patients were discharged home (70% initially and 90% to 94% in the last 3 years). During the first 5 years of the DH, there were 2612 emergency department (ED) visits that averaged 13 hours each. The combined ED and DH admissions during this time represented a 40% decrease in the baseline ED admission rate of 92%, (1 year pre-DH). Patients with uncomplicated painful crisis were admitted 5 times less often from the DH (8.3%) than from the ED (42.7%). The length of stay (LOS) for inpatients followed by the DH staff decreased by 1.5 days, while the LOS for patients followed by non-DH staff remained unchanged. Reduction of admissions and LOS represented a savings of approximately $1.7 million. We conclude that a dedicated facility provides the kingpin for effective and rapid painful crisis management, reduces hospitalizations, and facilitates integration of the approach into other areas of care. (Blood. 2000;95:1130-1136)

Predicting surgical outcome for pain relief and return to work.

BACKGROUND: We evaluated a new psychological test (Paindex) for identifying and quantifying psychological factors associated with poor surgical outcome, and predicting the degree of pain relief and return to work. METHOD: This test was administered to 120 randomly selected patients before carpal tunnel and laminectomy surgeries. RESULTS: This test correctly predicted the probability of pain relief and return to work in 46 of the 50 laminectomy patients (92%), and 63 of the 70 carpal tunnel patients (90%). The overall test sensitivity was 86% and the specificity 94%. CONCLUSION: These findings indicate that this can be a useful adjunctive test for identifying psychological problems that could have a bearing on the decision to operate and then problems that could occur after surgery, particularly in cases where the extent and degree of pain and disability are judged to be considerably in excess of the objective medical findings.