Optimal Strategies for Reporting Pain in Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12 Workshop Patient-perceived satisfactory improvement (PPSI): Interpreting meaningful change in pain from the patient’s perspective What constitutes a clinically important pain reduction in patients after third molar surgery? Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale What Is a Meaningful Pain Reduction in Patients With Complex Regional Pain Syndrome Type 1? Idiographic outcome analyses of the clinical significance of two interventions for patients with musculoskeletal pain. Sensitivity and Specificity of Outcome Measures in Patients with Neck Pain: Detecting Clinically Significant Improvement Effectiveness of a clinical intervention in improving pain control in outpatients with cancer treated by radiation therapy. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Pain measurement in persons with intellectual disabilities. Improving pain outcomes of hospice patients with cancer. Enriched Enrollment Randomized Withdrawal Trial Designs of Analgesics: Focus on Methodology Defining the clinically important difference in pain outcome measures Regression to the mean in treated versus untreated chronic pain Clinically important changes in acute pain outcome measures: a validation study. A randomized, clinical trial of education or motivational-interviewing-based coaching compared to usual care to improve cancer pain management. The clinical importance of changes in outcome scores after treatment for chronic low back pain
Objective . Pain is a patient-important outcome , but current reporting in r and omized controlled trials and systematic review s is often suboptimal , impeding clinical interpretation and decision making . Methods . A working group at the 2014 Outcome Measures in Rheumatology ( OMERACT 12 ) was convened to provide guidance for reporting treatment effects regarding pain for individual studies and systematic review s. Results For individual trials , authors should report , in addition to mean change , the proportion of patients achieving 1 or more thresholds of improvement from baseline pain ( e.g. , ≥ 20 % , ≥ 30 % , ≥ 50 % ) , achievement of a desirable pain state ( e.g. , no worse than mild pain ) , and /or a combination of change and state . Effects on pain should be accompanied by other patient-important outcomes to facilitate interpretation . When pooling data for meta analysis , authors should consider converting all continuous measures for pain to a 100 mm visual analog scale ( VAS ) for pain and use the established , minimally important difference ( MID ) of 10 mm , and the conventionally used , appreciably important differences of 20 mm , 30 mm , and 50 mm , to facilitate interpretation . Effects ≤ 0.5 units suggest a small or very small effect . To further increase interpretability , the pooled estimate on the VAS should also be transformed to a binary outcome and expressed as a relative risk and risk difference . This transformation can be achieved by calculating the probability of experiencing a treatment effect greater than the MID and the thresholds for appreciably important differences in pain reduction in the control and intervention groups . Conclusion . Presentation of relative effects regarding pain will facilitate interpretation of treatment effects Abstract The assessment of clinical ly meaningful changes in  patient‐reported pain  has become increasingly important when interpreting results of clinical studies . However , proposed response criteria , such as the minimal clinical ly important difference , do not correspond with the growing need for information on truly meaningful , individual improvements . The aim of the present study was to investigate satisfactory improvements in pain from the patient ’s perspective . Data were collected in a 2‐week prospect i ve study of 181 arthritis patients treated with a local corticosteroid injection .  Baseline and follow‐up pain were assessed on 100 mm visual analogue scales for pain intensity ( VAS‐PI ) . At baseline , patients also marked a hypothetical level on a VAS‐PI representing a satisfactory improvement in pain . Patient‐perceived satisfactory improvement ( PPSI ) was constructed using a 5‐point categorical rating of change scale at follow‐up as the anchor . PPSI was associated with a minimal reduction of 30 mm or 55 % on the VAS‐PI . Since absolute change in pain associated with satisfactory improvement proved highly dependent on baseline pain , percent change scores performed better in classifying improved patients . The 55 % threshold for satisfactory improvement was consistent over the course of treatment and reasonably consistent across groups of patients . Our data suggest that PPSI is a clinical ly relevant and stable concept for interpreting truly meaningful improvements in pain from the individual perspective BACKGROUND For patients with surgical third molar removal , it is unknown what constitutes a clinical ly important change in patients ' visual analogue scale ( VAS ) reports of pain intensity . OBJECTIVES To determine what constitutes a clinical ly important change in pain intensity on a VAS following surgical removal of the third molar . METHODS The study population consisted of patients participating in three r and omized trials . Patients were asked to rate their pain three times per day over a period of seven days on a 100 mm VAS after surgical removal of the third molar . Global Perceived Effect was measured on day 1 and day 7 and was used as the external criterion for assessing clinical ly important pain reduction . Global Perceived Effect scores of 6 ( ' much improved ' ) or higher were classified as clinical ly ' successful ' , and scores of 5 ( ' slightly improved ' ) or below were classified as clinical ly ' unsuccessful ' . For each trial , the mean absolute and relative changes in VAS scores were calculated for both ' successful ' and ' unsuccessful ' treatments . Sensitivity and specificity analyses were performed . RESULTS The patients who reported ' successful ' pain reduction showed a relative pain reduction of ≥69 % and an absolute pain reduction > 2.5 cm on the VAS , whereas patients who classified their pain reduction as ' unsuccessful ' had a relative pain reduction of ≤18.5 % and an absolute pain reduction < 0.5 cm on the VAS . Furthermore , sensitivity and specificity analyses showed that a cut-off point of ≥50 % relative pain reduction exhibited the best balance of sensitivity and specificity . CONCLUSION Relative pain reduction of ≥50 % and an absolute pain reduction of ≥2.5 cm on the VAS were most accurate in predicting a successful pain reduction after a given treatment & NA ;  Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies Objective To investigate the degree of  pain reduction  in patients with complex regional pain syndrome type 1 ( CRPS 1 ) that can be defined as “ successful . ” Design All patients rated their pain on a visual analog scale ( VAS ; 0–10 ) before treatment and on three occasions after treatment , at 6 months , 1 year , and 2 years . Patients also rated a Global Perceived Effect  ( GPE ) for their pain relief at the same time periods . The GPE items were classified as “ successful ” or “ unsuccessful . ” The mean absolute and relative pain reduction ( using the VAS ) was calculated for both “ successful ” and “ unsuccessful ” GPE classifications for each time period . Sensitivity and specificity analyses were performed . Patients Sixty-one patients with CRPS 1 . Results The patients defined a relative pain reduction of 58 % ( SD , 23.4 ) or more as “ successful , ” whereas in “ successful ” and “ unsuccessful ” patient groups the pain was reduced significantly on the VAS . Furthermore , sensitivity and specificity analyses showed that a cut-off point of 50 % relative pain reduction and a 3-cm absolute pain reduction on the VAS have the highest likelihood that patients will report their treatment “ successful ” on the GPE . Conclusions Relative pain reduction of 50 % or more and an absolute pain reduction of at least 3 cm on the VAS are accurate in predicting a successful pain reduction after a given treatment UNLABELLED This study adopted a perspective of the individual to define domains of everyday life for the analysis of clinical ly meaningful change . The purpose was to compare the clinical significance of two interventions for patients with musculoskeletal pain , applying an idiographic outcome measure , The Patient Goal Priority Question naire , in combination with the Jacobson and Truax methodology [ ( 1991 ) . CLINICAL SIGNIFICANCE A statistical approach to defining meaningful change in psychotherapy research . Journal of Consulting and Clinical Psychology , 67 ( 3 ) , 300 - 307 ] for determination of clinical significance . The concurrent validity of the outcome variables behavioral performance , satisfaction with behavioral performance , and fulfilled pre-treatment expectations was also studied . Eighty-two patients , r and omized to either individually tailored behavioral medicine treatment ( experimental group ) or physical exercise therapy ( control group )  were evaluated at baseline and 3 months post-treatment regarding behavioral treatment goals . The experimental intervention had high impact on participants ' performance of their highest ranked everyday life activities , and result ed in larger proportions of clinical ly significant outcomes compared with controls . The concurrent validity of the outcomes was high for those reporting clinical ly significant changes , but more generally , there was a moderate agreement across outcome categories . The individual should be the unit for analyses of clinical significance to enhance the ecological validity of the construct . Further development of idiographic outcome measures is necessary , as is the inclusion in pain intervention research Study Design . Prospect i ve , single-cohort study . Objective . To determine the relative sensitivity of a range of outcome measures used in evaluating treatment interventions in patients with neck pain and the magnitude of change scores on the neck Bournemouth Question naire and the cutoff score on the Patients ’ Global Impression of Change scale associated with clinical ly significant improvement . Summary of Background Data . Traditionally , evaluation of treatment interventions using subjective outcome measures has been based on the statistical significance of the difference between group mean values . To be clinical ly meaningful , however , information is required from sensitive outcome measures on the proportion of patients undergoing a clinical ly important improvement and from this , the number needed to treat for a single patient to benefit . Methods . Patients with nonspecific neck pain from a number of treatment centers completed a battery of self-report question naires , including the Bournemouth Question naire , before and after chiropractic treatment . After treatment , patients also completed a retrospective analysis of their overall improvement since the start of treatment ( Patients ’ Global Impression of Change ) . The a priori definition of clinical ly significant improvement was defined as a Reliable Change Index on the Bournemouth Question naire of > 1.96 . Results . The best cutoffs with a balance between the highest sensitivity and highest specificity in detecting clinical improvement were a score of 2 or less on the Patients ’ Global Impression of Change ( 11-point Numerical Rating Scale : 0 = much better , 5 = no change , and 10 = much worse ) and a raw change score of three or more points on each of the seven 11-point Numerical Rating Scale subscales of the Bournemouth Question naire . For the total score of the Bournemouth Question naire , raw change scores of 13 or more points , percentage change scores of 36 % or more , and individual effect sizes of 1.0 or more were all associated with clinical ly significant improvement . The sensitivity of the Bournemouth Question naire in terms of its effect size was comparable with that of pain intensity scales and the Neck Disability Index . Conclusions . The present findings will assist in the choice of outcome measures in trials on neck pain . The study also illustrates a method ologic framework for interpreting change scores in terms of clinical improvement , facilitating the process of making sense of research data in the clinical setting PURPOSE To determine the effectiveness of a multicomponent clinical intervention to reduce pain in out patients with cancer . METHODS AND MATERIAL S Sixty-four patients were r and omly assigned to receive either a clinical intervention including an information session , the use of a pain diary , and the possibility to contact a physician to adjust the pain medication , or the usual treatment of pain by the staff radiation oncologist . All patients reported their average and worst pain levels at baseline and 2 and 3 weeks after the start of the intervention . RESULTS The study groups were similar with respect to their baseline characteristics and pain levels at r and omization . After 3 weeks , the average and worst pain experienced by patients r and omized to the clinical intervention group was significantly inferior to the average pain experienced by patients in the control group ( 2.9/10 vs. 4.4/10 and 4.2/10 vs. 5.5/10 , respectively ) . Results showed that the experimental group patients decreased their pain levels more than the control group patients did over time . CONCLUSION An intervention including  patient education , a pain diary , and defining a procedure for therapeutic adjustments  can be effective to improve pain relief in out patients with cancer STUDY DESIGN A double-blind , r and omized controlled trial of a novel educational booklet compared with a traditional booklet for patients seeking treatment in primary care for acute or recurrent low back pain . OBJECTIVE To test the impact of a novel educational booklet on patients ' beliefs about back pain and functional outcome . SUMMARY OF BACKGROUND DATA The information and advice that health professionals give to patients may be important in health care intervention , but there is little scientific evidence of their effectiveness . A novel patient educational booklet , The Back Book , has been developed to provide evidence -based information and advice consistent with current clinical guidelines . METHODS One hundred sixty-two patients were given either the experimental booklet or a traditional booklet . The main outcomes studied were fear-avoidance beliefs about physical activity , beliefs about the inevitable consequences of back trouble , the Rol and Disability Question naire , and visual analogue pain scales . Postal follow-up response at 1 year after initial treatment was 78 % . RESULTS Patients receiving the experimental booklet showed a statistically significant greater early improvement in beliefs which was maintained at 1 year . A greater proportion of patients with an initially high fear-avoidance beliefs score who received the experimental booklet had clinical ly important improvement in fear-avoidance beliefs about physical activity at 2 weeks , followed by a clinical ly important improvement in the Rol and Disability Question naire score at 3 months . There was no effect on pain . CONCLUSION This trial shows that carefully selected and presented information and advice about back pain can have a positive effect on patients ' beliefs and clinical outcomes , and suggests that a study of clinical ly important effects in individual patients may provide further insights into the management of low back pain OBJECTIVE The goal was to study the utility of nonverbal facial expressions as a research tool for assessing pain in persons with intellectual disabilities . Biases and stereotypes related to age , gender , physical attractiveness , and intellectual disability that may influence the ability of observers to evaluate pain reactions were also examined . DESIGN Facial reactions to an intramuscular injection of 40 adults ( mean age = 49.6 years ) with an intellectual disability were videotaped and objective ly examined using the Facial Action Coding System . Self-reported pain ratings were obtained using a Colored Visual Analogue Scale for pain . Pain reactions were also rated by untrained observers . RESULTS A significant proportion of participants ( 35 % ) was unable to provide valid self-report . The intensity of objective ly coded facial activity as well as observer-rated pain intensity showed significant increases from baseline to injection segments . Observers ' pain ratings were primarily determined by the intensity of facial activity and were not significantly affected by stereotypes based on perceived level of intellectual disability , gender , age , or physical attractiveness . CONCLUSIONS The findings support the validity of both objective ly coded and observer-rated facial expressions of pain as research tools in treatment outcome studies involving persons with intellectual disabilities . Self-report has substantial limitations for the assessment of pain in this population PURPOSE / OBJECTIVES To evaluate the success of a multifaceted , hospicewide , nurse-focused pain-management intervention for improving patient pain outcomes . DESIGN Comparative , descriptive . SETTING A large , nonprofit hospice that primarily provides home care . SAMPLE Two sample s were included in the study . One sample ( n = 47 ) was from a study completed in 1995 before the intervention , and one ( n = 255 ) was from a study completed in 1997 after the intervention . All patients had been diagnosed with cancer and were alert and able to self-report . METHODS Secondary analysis of data that were collected as part of two quality -of-life studies . The four-part intervention included intensive pain-management education for the nurses , development and implementation of pain-management policies and procedures , changes in pain assessment and management documentation , and development and use of quality assurance monitors by the nursing staff . MAIN RESEARCH VARIABLES Pain at its worst , pain relief , and quality of life . FINDINGS Adjusted mean pain-relief scores were significantly lower in 1995 ( X = 5.8 ) than in 1997 ( X = 8.4 ) . In 1995 , 43 % of patients reported pain relief at a level of 5 or less ( on a 0 - 10 scale ) . This number dropped to 10 % by 1997 . Adjusted mean pain-at-its-worst scores were significantly lower in 1997 ( X = 6.1 ) than in 1995 ( X = 6.7 ) . Pain relief was found to be positively correlated ( r = 0.41 - 0.51 ) with quality of life in both sample s. CONCLUSIONS The hospicewide pain-management intervention was effective . IMPLICATION S FOR NURSING PRACTICE Through careful study and multifaceted nurse-focused interventions , pain outcomes of hospice patients with cancer can be improved Objectives To systematic ally identify and critically assess clinical trials that use enriched enrollment r and omized withdrawal ( EERW ) trial design as a methodology for assessing the effect of analgesics pain . Methods A comprehensive literature search was conducted through April 2007 in Medline and Embase to identify all r and omized controlled trials that use EERW trial design s. Data were collected from relevant trials and tabulated . Results were categorized on the basis of study design s , preenrichment and postenrichment disposition , discontinuation rates , primary and secondary efficacy results , and respective P values . Results The literature search identified 2875 unique citations , most of which were deemed inappropriate for this analysis . The primary reasons for exclusion included inappropriate study design , no available abstract , not a clinical study , and therapeutic area not related to chronic pain . Eight EERW clinical trials of analgesics were identified . Half of the trials were in chronic low back pain , and 5 of 8 trials used an opioid as the active drug . Of the 8 trials , 5 used a parallel design and 3 used crossover design s. The primary efficacy parameter used was pain scores or time to discontinuation , and statistically and clinical ly significant effects in active treatments relative to placebo were observed after r and omization in all trials . The median magnitude of effect was 1.7 on a 10-point scale . Time to exit was a more statistically powerful endpoint than mean pain intensity . Discussion sEERW trials are an emerging type of study design that in certain setting s may offer advantages over traditional trial design s in characterizing the effects of analgesic medications & NA ; The purpose of this study was to determine the levels of change on st and ard pain scales that represent clinical ly important differences to patients . Data from analgesic studies are often difficult to interpret because the clinical importance of the results is not obvious . Differences between groups , as summarized by a change in mean values over time , can be difficult to apply to clinical care . Baseline scores vary widely and group mean differences could reflect large changes in a few patients , small changes in many patients , or any combination of these outcomes . Determination of the proportion of patients who have a clinical ly important improvement in their pain would provide a more interpretable result with direct clinical implication s. However , determining a clinical ly important outcome requires information about the degree of change over time that is clinical ly important . Data from the titration phase of a multiple cross‐over r and omized clinical trial of oral transmucosal fentanyl citrate ( OTFC )  for the treatment of cancer‐related breakthrough pain were re‐analyzed to examine the differences in pain scores between treatment episodes that did and did not yield adequate pain relief . The scales evaluated were absolute pain intensity difference ( PID , 0–10 scale ) , percentage pain intensity difference ( PID% , 0–100 % scale ) , pain relief ( PR , 0 ( none ) , 1 ( slight ) , 2 ( moderate ) , 3 ( lots ) , 4 ( complete ) ) , sum of the pain intensity difference ( SPID over 60 min ) , percentage of maximum total pain relief ( % Max TOTPAR over 60 min ) , and global medication performance ( 0 ( poor ) , 1 ( fair ) , 2 ( good ) , 3 ( very good ) , 4 ( excellent ) ) . Adequate relief was defined by the patient 's decision not to use another dose of opioid medication as a rescue , in addition to the study medication , to treat each painful episode . One hundred thirty OTFC naive patients contributed data on 1268 episodes of breakthrough pain . The scales that were converted to a percentage change yielded the best accuracy in predicting adequate relief , with balanced sensitivity and specificity . The best cut‐off point for both the % Max TOTPAR and the PID% was 33 % . The best cut‐off points for the absolute scales were absolute pain intensity difference of 2 , pain relief of 2 ( moderate ) , and SPID of 2 . The global medication performance of 2 ( good ) had excellent values as well . This study presents data ‐derived cut‐off points for the changes in several pain scales , each reflecting the clinical ly important improvement for patients treating breakthrough cancer pain episodes with OTFC . Confirmation in other patient population s and different pain syndromes will be needed . The use of consistent clinical ly important cut‐off points as the primary outcome in future pain therapy clinical trials will enhance their validity , comparability , and clinical applicability & NA ; The course of pain associated with temporom and ibular disorders ( TMD ) and other chronic pain conditions is typically episodic . Its expression may influence when a person seeks treatment , for example , when the level of pain flares up or exceeds its characteristic severity . Improvement in pain status subsequent to entering treatment may be due to : ( 1 ) specific effects of treatment ; ( 2 ) non‐specific effects of treatment ( ‘ placebo effects ’ ) ; or ( 3 ) regression to the mean . Due to regression to the mean , uncontrolled evaluation of treatment in persons self‐selected by a pain flare‐up may lead to erroneous conclusions concerning effects of treatment by patients , providers , and /or research ers . For this report , the magnitude of regression to the mean due to self‐ selection for treatment is estimated by comparing subjects who sought treatment for TMD pain ( n = 147 ) to a r and om sample of subjects with TMD pain not seeking treatment ( n = 95 . Among subjects seeking treatment , a significant 14.7‐point reduction in VAS pain intensity was observed at 1‐year follow‐up . A control group of TMD subjects not seeking treatment  showed no mean reduction in pain intensity but reported lower pain intensity at baseline than the group seeking care . When both groups of subjects were stratified on baseline VAS pain values , the reduction in pain increased as the baseline pain level increased , but no differences between comparable treated and untreated cases in the extent of improvement were observed . The before‐after differences in both groups may be attributed to regression to the mean . We conclude that before‐after differences in pain intensity can be large and that such improvement may be largely due to regression to the mean . This suggests the need for research which differentiates change due to regression to the mean ( due to homeostatic processes , r and om within‐subject variation , or measurement error ) from change due to specific and non‐specific effects of treatment . In clinical practice , the personal experience of patients and clinicians who observe improvement after initiation of treatment should be regarded as an unreliable guide to treatment efficacy due to regression to the mean . This phenomenon may contribute to the proliferation and continued use of treatments of unproven efficacy for pain management and suggests caution in the use of costly or risky pain treatments the efficacy of which is unknown The purpose of this study was to vali date the changes in acute pain measurement scales that are most strongly associated with a patient-determined indicator of clinical importance . Measures of pain intensity and pain relief are commonly used outcomes in therapeutic clinical trials . Recent studies of the properties of acute pain measures have provided data defining the cut-off points that are best associated with clinical ly important differences . Validation of these findings in another clinical trial data set is important . Data were obtained from the titration phase of a recently conducted r and omized controlled clinical trial of oral transmucosal fentanyl citrate ( OTFC ) , which compared OTFC to immediate release morphine sulfate ( MSIR ) for the treatment of cancer-related acute breakthrough pain .  Changes in pain intensity and pain relief were recorded every 15 minutes for 60 minutes and global medication performance recorded at the end of each study pain episode . At any titration step , if the patient felt that the first dose of the study medication did not provide adequate relief within 30 minutes , an additional rescue medication could be taken . To find the level of each pain scale best associated with this measure of the adequacy of pain relief , the calculated sensitivity , specificity , and accuracy for different cut-off points of the measured pain scales were compared to whether or not the patient needed rescue medication . The overall ability of the pain measures to discriminate episodes for which a rescue was not needed was calculated using area under the receiver operating characteristics ( ROC ) curves . Data were analyzed from 134 OTFC-naive patients who collected data on 1307 episodes of breakthrough pain . Using the criteria of a balanced sensitivity and specificity , the best cut-off points were determined to be : 33 % for the percent pain intensity difference ; > or = 2 for the raw pain intensity difference on a 0 - 10 numeric rating scale ; > or = 2 ( i.e. , moderate or better ) for pain relief ; > or = 33 % for the percent maximum total pain relief ; and > or = 2 ( good or better ) for global medication performance . ROC area under the curve ranged from 0.839 to 0.862 for each of the pain measures listed above , calculated at 60 minutes . These data indicate that the pain scale cut-off points that are best associated with a patient-derived measure of a clinical ly important difference closely approximate those found in an earlier study . ROC analysis provided evidence that the overall pain measures were strongly associated with not requiring an " additional dose of rescue medication . " Thus , the cut-off points determined for these pain scales provide a good surrogate measure of a patient-determined clinical ly important response . This provides support for the usefulness of these values in future clinical trials of pain therapy PURPOSE / OBJECTIVES To test the effectiveness of two interventions compared to usual care in decreasing attitudinal barriers to cancer pain management , decreasing pain intensity , and improving functional status and quality of life ( QOL ) . DESIGN R and omized clinical trial . SETTING Six outpatient oncology clinics ( three Veterans Affairs [ VA ] facilities , one county hospital , and one community-based practice in California , and one VA clinic in New Jersey ) Sample : 318 adults with various types of cancer-related pain . METHODS Patients were r and omly assigned to one of three groups : control , st and ardized education , or coaching . Patients in the education and coaching groups viewed a video and received a pamphlet on managing cancer pain . In addition , patients in the coaching group participated in four telephone sessions with an advanced practice nurse interventionist using motivational interviewing techniques to decrease attitudinal barriers to cancer pain management . Question naires were completed at baseline and six weeks after the final telephone calls . Analysis of covariance was used to evaluate for differences in study outcomes among the three groups . MAIN RESEARCH VARIABLES Pain intensity , pain relief , pain interference , attitudinal barriers , functional status , and QOL . FINDINGS Attitudinal barrier scores did not change over time among groups . Patients r and omized to the coaching group reported significant improvement in their ratings of pain-related interference with function , as well as general health , vitality , and mental health . CONCLUSIONS Although additional evaluation is needed , coaching may be a useful strategy to help patients decrease attitudinal barriers toward cancer pain management and to better manage their cancer pain . IMPLICATION S FOR NURSING By using motivational interviewing techniques , advanced practice oncology nurses can help patients develop an appropriate plan of care to decrease pain and other symptoms Abstract . When measuring treatment effect in chronic low back pain with multi-item outcome instruments , it is necessary , both for clinical decision-making and research purpose s , to underst and the clinical importance of the outcome scores . The aims of the present study were three-fold . Firstly , it aim ed to estimate the minimal clinical ly important difference of three multi-item outcome instruments ( the Oswestry Disability Index , the General Function Score and the Zung Depression Scale )  and of the  visual analogue scale ( VAS ) of back pain .  Secondly , it aim ed to estimate the error of measurement of these instruments ; and its third aim was to describe the clinical meaning of score change . The study population consisted of 289 patients treated surgically or non-surgically in a r and omised controlled trial . The minimal clinical ly important difference was estimated with patient global assessment as the external criterion . It was compared with the st and ard error of measurement of the instruments . The individual items of the instruments were compared for score changes related to improvement and deterioration . The st and ard error of measurement of the Oswestry Disability Index , the General Function Score and the Zung Depression Scale was 4 , 6 and 3 units , respectively . The 95 % tolerance interval was 10 , 16 and 8 units , respectively . The minimal clinical ly important difference was 10 , 12 and 8–9 units , respectively , thus not significantly exceeding the tolerance interval . The minimal clinical ly important difference of VAS back pain was 18–19 units , well exceeding the 95 % tolerance interval , which was 15 units . Improvement after treatment for chronic low back pain tends to occur to a greater extent in sleep disturbance , ability to do usual things and psychological irritability , but to a lesser extent in the ability to sit , st and and lift . We conclude that the VAS of back pain is responsive enough to detect the minimal clinical ly important difference , whereas the smallest acceptable score changes of the Oswestry Disability Index , the General Function Score and the Zung Depression Scale may require an increase to exceed the 95 % tolerance interval when used for clinical decision making and for power calculation . Despite improvement after treatment , the ability to sit , st and and lift , remain notable problems
Our review revealed a great heterogeneity in definition , format , and values of what is considered a clinical ly relevant difference in pain in RCTs of analgesics , and st and ardizations are advisable
OBJECTIVE To describe the  pain decrease considered as clinical ly relevant when design ing a trial and reporting its results .