Optimal Strategies for Reporting Pain in Clinical Trials and Systematic Reviews: Recommendations from an OMERACT 12 Workshop Rationale, design, and implementation protocol of the Dutch clinical practice guideline Pain in patients with cancer: a cluster randomised controlled trial with short message service (SMS) and interactive voice response (IVR) Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations A pathway linking patient participation in cancer consultations to pain control. Evidence-based postoperative pain management in nursing: is a randomized-controlled trial the most appropriate design? Comparing the clinical-effectiveness and cost-effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: study protocol for a randomised controlled trial Determining the effectiveness of a clinical‐practice intervention in improving the control of pain in outpatients with cancer Implementing guidelines for cancer pain management: results of a randomized controlled clinical trial. Addressing methodological challenges in implementing the nursing home pain management algorithm randomized controlled trial Using the "TOPS," an outcomes instrument for multidisciplinary outpatient pain treatment. Improving pain outcomes of hospice patients with cancer. IMPROVE trial: A randomized controlled trial of patient-controlled analgesia for sickle cell painful episodes: rationale, design challenges, initial experience, and recommendations for future studies Effectiveness of a clinical intervention in improving pain control in outpatients with cancer treated by radiation therapy. Postsurgical pain outcome assessment An educational intervention to reduce pain and improve pain management for Malawian people living with HIV/AIDS and their family carers: study protocol for a randomised controlled trial Advances in clinical research methodology for pain clinical trials Generalizing from a controlled trial: the effects of patient preference versus randomization on the outcome of inpatient versus outpatient chronic pain management
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 Background One-half of patients with cancer have pain .  In nearly one out of two cancer patients with  pain , this was undertreated . Inadequate pain control still remains an important problem in this group of patients . Therefore , in 2008 a national , evidence -based multidisciplinary clinical practice guideline ' pain in patients with cancer ' has been developed . Yet , publishing a guideline is not enough . Implementation is needed to improve pain management . An innovative implementation strategy , Short Message Service with Interactive Voice Response ( SVS-IVR ) , has been developed and pilot tested . This study aims to evaluate on effectiveness of this strategy to improve pain reporting , pain measurement and adequate pain therapy . In addition , whether the active role of the patient and involvement of caregivers in pain management may change . Methods / design A cluster r and omised controlled trial with two arms will be performed in six oncology outpatient clinics of hospitals in the Southeastern region of the Netherl and s , with three hospitals in the intervention and three in the control condition . Follow-up measurements will be conducted in all hospitals to study the long-term effect of the intervention . The intervention includes training of professionals ( medical oncologists , nurses , and general practitioners ) and SMS-IVR to report pain in patients with cancer  to improve pain reporting by patients , pain management by medical oncologists , nurses , and general practitioners , and decrease pain intensity . Discussion This innovative implementation strategy with technical tools and the involvement of patients , may enhance the use of the guideline ' pain in patients with cancer ' for pain management . Short Message Service alerts may serve as a tool to support self-management of patients . Therefore , the SMS-IVR intervention may increase the feeling of having control over one 's life . Trail registration Netherl and s Trial Register ( NTR ) : & NA ; Adverse events in r and omized controlled trials of noninvasive , pharmacologic analgesics are frequently incompletely or inconsistently reported . A comprehensive reporting checklist is proposed to improve disclosure of adverse effects . & NA ; The development of valid and informative treatment risk – benefit profiles requires consistent and thorough information about adverse event ( AE ) assessment and participants ’ AEs during r and omized controlled trials ( RCTs ) . Despite a 2004 extension of the Consoli date d St and ards of Reporting Trials ( CONSORT ) statement recommending the specific AE information that investigators should report , there is little evidence that analgesic RCTs adequately adhere to these recommendations . This systematic review builds on prior recommendations by describing a comprehensive checklist for AE reporting developed to capture clinical ly important AE information . Using this checklist , we coded AE assessment methods and reporting in all 80 double‐blind RCTs of noninvasive pharmacologic treatments published in the European Journal of Pain , Journal of Pain , and PAIN ® from 2006 to 2011 . Across all trials , reports of AEs were frequently incomplete , inconsistent across trials , and , in some cases , missing . For example , > 40 % of trials failed to report any information on serious adverse events . Trials of participants with acute or chronic pain conditions and industry‐sponsored trials typically provided more and better‐ quality AE data than trials involving pain‐free volunteers or trials that were not industry sponsored . The results of this review suggest that improved AE reporting is needed in analgesic RCTs . We developed an ACTTION ( Analgesic , Anesthetic , and Addiction Clinical Trial Translations , Innovations , Opportunities , and Networks ) AE reporting checklist that is intended to assist investigators in thoroughly and consistently capturing and reporting these critically important data in publications OBJECTIVE To test a pathway through which a tailored , pain management education-coaching intervention could contribute to better  cancer pain control through the effects of patients ' communication about pain on physician prescribing of pain medication . METHODS Secondary analysis of data from a r and omized controlled trial that tested the effects of a tailored education-coaching intervention on pain control for patients with advanced cancer . The current analysis focused on a subset of the patients ( n = 135 ) who agreed to have their consultations audio-recorded . Patients ' active communication about pain ( e.g. , expressing questions , concerns , and preferences about pain-related issues ) was coded from audio-recordings . Change in pain medication was measured by patient self-report . Improvement in pain control was scored as the difference between baseline pain score and pain reported at 6 weeks . RESULTS Patients ' pain-related communication was a significant predictor of patient-reported changes in physician prescribing of pain medication ( p < .0001 ) and mediated the effect of baseline pain on medication change . Other predictors of change in pain medication were age ( younger ) and having participated in the intervention ( as opposed to usual care ) . Of the patients reporting adjustment in pain medications , 49 % experienced better pain control compared with only 27 % of patients reporting no change in pain management ( p < .02 ) . CONCLUSIONS Cancer patients who ask questions , express concerns , and state preferences about pain-related matters can prompt physicians to change their pain management regimen , which in turn may lead to better pain control . Future research should model pathways through which clinician-patient communication can lead to better cancer outcomes There is an increasing drive to make nursing care evidence -based . High quality evidence from systematic review s relevant to postoperative pain relief exists , yet pain after surgery remains poorly controlled for many patients . This study aim ed to assess whether implementing evidence -based pain management improved postoperative pain outcomes . Pain on a 0 - 10 scale was the primary outcome and analgesic consumption a secondary outcome . A baseline audit was undertaken on four surgical wards to establish whether there was a need for the study . A r and omized-controlled trial was then design ed to assess the effects of implementing an evidence -based approach to postoperative pain management .  The four wards were r and omized to receive the intervention or act as a control . Outcomes were assessed 3 months after the intervention on both intervention and control wards . The intervention ( implementation of an oral analgesic algorithm derived from systematic review s ) was then implemented on the control wards and outcomes reassessed after 3 months on the control wards . The intervention was design ed using an evidence -based approach to effective implementation . Four interactive sessions covered : ( 1 ) detailed feedback of baseline data and discussion ( utilizing audit and feedback ) , ( 2 ) why systematic review s , analgesic league tables and choice of drugs to develop an analgesic algorithm ( see Figure 1 ) , ( 3 ) principles of evidence based health care ( EBHC ) , including critical appraisal and ( 4 ) facilitation and change workshop . The findings revealed no significant differences in pain level or drug use between the intervention and control wards . However , the control wards also changed during the control period . Possible explanations for this are discussed . When looking at changes compared with baseline , both intervention and control wards increased their use of algorithm drugs and reduced use of non-algorithm drugs during the study . No effects were found on pain in the intervention wards . Pain ratings at rest since surgery , on movement since surgery and worst pain on movement were significantly reduced compared with baseline in the control wards . Although there are many pressures to utilize a r and omized-controlled trial study design in the culture of evidence -based health care , there will be times , especially when implementing complex changes in practice that other types of design should be considered Introduction Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence -based psychological treatment in the Irish health service context . While the use of internet-delivered cognitive – behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain , there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy ( ACT ) programme among people with chronic pain . The current study will compare the clinical -effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain . Methods and analysis Participants with non-malignant pain that persists for at least 3 months will be r and omised to one of two study conditions . The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period . The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period . Participants will be assessed preintervention , postintervention and at a 3-month follow-up . The primary outcome will be pain-related functional interference . Secondary outcomes will include : pain intensity , depression , global impression of change , acceptance of chronic pain and quality of life . A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial . Ethics and dissemination The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Irel and Galway Research Ethics Committee ( 12/05/05 ) . The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer- review ed journals . Trial registration number IS RCT N18166896 PURPOSE : To determine the effectiveness of a clinical - practice intervention in improving the control of pain in out patients with cancer . METHOD : Between July 5 and September 30 , 1995 , a r and omized , controlled trial of 510 cancer out patients and 13 oncologists was conducted at 23 clinics in Indiana . All the patients completed assessment s of their pain , their pain regimens , and the degrees of relief received ; they were surveyed again by mail four weeks after their clinic visits . The intervention group 's clinical charts contained a summary of the completed pain scales ; the oncologists who treated these patients were instructed to review the summary sheet prior to an evaluation . This summary was not available for the oncologists treating the patients in the control group . Each patient 's pain management index ( PMI ) was calculated : the patient 's pain medication level was rated on a scale of 0 to 3 ; the patients 's pain level was rated on a scale of 0 to 3 and then subtracted from the first rating . A negative PMI was interpreted as representing insufficient treatment . Data were analyzed with several statistical tests . RESULTS : In all , only 320 patients who reported cancer-related pain were used in the analysis : 160 to 260 in the control group and 160 of 250 in the intervention group . The groups were similar with respect to demographics , cancer sites , and performance status . A significant difference ( p = .0162 ) in the physicians ' prescription patterns was found . In the control group , prescriptions for 86 % of the patients did not change , with no decrease in analgesic prescriptions ; for 14 % of the patients analgesic prescriptions increased . In the intervention group , analgesic prescriptions changed for 25 % of the patients , decreasing for 5 % and increasing for 20 % . A decrease in the incidence of pain described as more than life 's usual aches and pains was found for the intervention group ( p = .05 ) . No significant difference was found between the groups for the patients undertreated for pain , as measured by PMIs . CONCLUSION : Although analgesic regimens were altered significantly when the physicians understood more about the patient 's pain , cancer pain management remains a complex problem . Future studies should focus on the long-term systematic incorporation of simple pain- assessment tools into daily outpatient oncology practice s as well as on innovative ways to address other aspects of managing cancer pain PURPOSE  Pain and symptom management  is an integral part of the clinical practice of oncology . A number of guidelines have been developed to assist the clinician in optimizing comfort care . We implemented clinical guidelines for cancer pain management in the community setting and evaluated whether these guidelines improved care . PATIENTS AND METHODS Eighty-one cancer patients , aged 37 to 76 years , were enrolled onto a prospect i ve , longitudinal , r and omized controlled study from the outpatient clinic setting s of 26 western Washington-area medical oncologists . A multilevel treatment algorithm based on the Agency for Health Care Policy and Research Guidelines for Cancer Pain Management was compared with st and ard- practice ( control ) pain and symptom management therapies used by community oncologists . The primary outcome of interest was pain ( Brief Pain Inventory ) ; secondary outcomes of interest were all other symptoms ( Memorial Symptom Assessment Scale ) and quality of life ( Functional Assessment of Cancer Therapy Scale ) . RESULTS Patients r and omized to the pain algorithm group achieved a statistically significant reduction in usual pain intensity , measured as slope scores , when compared with st and ard community practice ( P < .02 ) . Concurrent chemotherapy and patient adherence to treatment were significant mediators of worst pain . There were no significant differences in other symptoms or quality of life between the two treatment groups . CONCLUSION This guideline implementation study supports the use of algorithmic decision making in the management of cancer pain . These findings suggest that comprehensive pain assessment and evidence -based analgesic decision-making processes do enhance usual pain outcomes Background Unrelieved pain among nursing home ( NH ) residents is a well-documented problem . Attempts have been made to enhance pain management for older adults , including those in NHs . Several evidence -based clinical guidelines have been published to assist providers in assessing and managing acute and chronic pain in older adults . Despite the proliferation and dissemination of these practice guidelines , research has shown that intensive systems-level implementation strategies are necessary to change clinical practice and patient outcomes within a health-care setting . One promising approach is the embedding of guidelines into explicit protocol s and algorithms to enhance decision making . Purpose The goal of the article is to describe several issues that arose in the design and conduct of a study that compared the effectiveness of pain management algorithms coupled with a comprehensive adoption program versus the effectiveness of education alone in improving evidence -based pain assessment and management practice s , decreasing pain and depressive symptoms , and enhancing mobility among NH residents . Methods The study used a cluster-r and omized controlled trial ( RCT ) design in which the individual NH was the unit of r and omization . The Roger ’s Diffusion of Innovations theory provided the framework for the intervention . Outcome measures were surrogate-reported usual pain , self-reported usual and worst pain , and self-reported pain-related interference with activities , depression , and mobility . Results The final sample consisted of 485 NH residents from 27 NHs . The investigators were able to use a staggered enrollment strategy to recruit and retain facilities . The adaptive r and omization procedures were successful in balancing intervention and control sites on key NH characteristics . Several strategies were successfully implemented to enhance the adoption of the algorithm . Limitations /Lessons The investigators encountered several method ological challenges that were inherent to both the design and implementation of the study . The most problematic issue concerned the measurement of outcomes in persons with moderate to severe cognitive impairment . It was difficult to identify valid , reliable , and sensitive outcome measures that could be applied to all NH residents regardless of the ability to self-report . Another challenge was the inability to incorporate advances in implementation science into the ongoing study Conclusions Method ological challenges are inevitable in the conduct of an RCT . The need to optimize internal validity by adhering to the study protocol is compromised by the emergent logistical issues that arise during the course of the study OBJECTIVE To assess the reliability of an augmented SF-36 instrument , the Treatment Outcomes in Pain Survey  ( "  TOPS  " ) , in patients treated in two pain management programs , and present norms for initial values and treatment-related improvements . DESIGN Prospect i ve case series at two sites with longitudinal follow-up . SETTING Multidisciplinary , comprehensive outpatient pain treatment centers in university hospitals in Salt Lake City and Boston . PATIENTS Nine hundred and forty seven adult out patients with a range of socioeconomic , demographic , and ethnic characteristics , all referred for evaluation and treatment of chronic pain . INTERVENTIONS Usual practice multidisciplinary pain treatment . OUTCOMES MEASURES TOPS prior to pain treatment and 5-week nominal follow-up . Means and st and ard deviations of baseline and follow-up results . Psychometric results for reliability ( Cronbach alpha ) , validity ( item discriminant validity , validity coefficients ) , and related statistical precision measures for group and individual design s. RESULTS Several measures were precise enough to permit following individual patients in st and ard clinic treatment , of which the Total Pain Experience dimension was the most powerful . Similar psychometrics were observed in the Boston and Salt Lake City sites . The Pain Symptom , Objective Family/Social Disability , Objective Work Disability , and Upper Body Functional Limitations scales were vali date d. DISCUSSION The TOPS was design ed to satisfy several models of clinical pain treatment . It successfully monitored treatment based on those models . Not all patients improve with treatment , but most do . The TOPS can be administered in a variety of ways , but we found paper and pencil administration with computer scanning of results quick and efficient for making the data available to clinicians as part of treatment . CONCLUSIONS The accuracy of the TOPS is sufficient to monitor the response of individual patients during multidisciplinary treatment of chronic pain . The TOPS provides needed documentation ( e.g. , to third-party payors ) of the aggregate value of multidisciplinary outpatient treatment of chronic pain as well as its benefit for individual patients 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 Background The hallmark of sickle cell disease ( SCD ) is pain from a vaso-occlusive crisis . Although ambulatory pain accounts for most days in pain , pain is also the most common cause of hospitalization and is typically treated with parenteral opioids . The evidence base is lacking for most analgesic practice in SCD , particularly for the optimal opioid dosing for patient-controlled analgesia ( PCA ) , in part because of the challenges of the trial design and conduct for this rare disease . Purpose The purpose of this report is to describe our Network ’s experiences with protocol development , implementation , and analysis , including overall study design , the value of pain assessment s rather than ‘ crisis ’ resolution as trial endpoints , and alternative statistical analysis strategies . Methods The Improving Pain Management and Outcomes with Various Strategies ( IMPROVE ) PCA trial was a multisite inpatient r and omized controlled trial comparing two PCA-dosing strategies in adults and children with SCD and acute pain conducted by the SCD Clinical Research Network . The specified primary endpoint was a 25-mm change in a daily average pain intensity using a Visual Analogue Scale , and a number of related pain intensity and pain interference measures were selected as secondary efficacy outcomes . A time-to-event analysis strategy was planned for the primary endpoint . Results Of 1116 individuals admitted for pain at 31 participating sites over a 6-month period , 38 were r and omized and 4 withdrawn . The trial was closed early due to poor accrual , reflecting a substantial number of challenges encountered during trial implementation . Limitations While some of the design issues were unique to SCD or analgesic studies , many of the trial implementation challenges reflected the increasing complexity of conducting clinical trials in the inpatient setting with multiple care providers and evolving electronic medical record systems , particularly in the context of large urban academic medical centers . Lessons learned Complicated clinical organization of many sites likely slowed study initiation . More extensive involvement of research staff and site principal investigator in the clinical care operations improved site performance . During the subsequent data analysis , alternative statistical approaches were considered , the results of which should inform future efficacy assessment s and increase future trial recruitment success by allowing substantial reductions in target sample size . Conclusions A complex r and omized analgesic trial was initiated within a multisite disease network seeking to provide an evidence base for clinical care . A number of design considerations were shown to be feasible in this setting , and several pain intensity and pain interference measures were shown to be sensitive to time- and treatment-related improvements . While the premature closure and small sample size precluded definitive conclusions regarding treatment efficacy , this trial furnishes a template for design and implementation considerations that should improve future SCD analgesic trials 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 & NA ; Reliable and valid measures of pain are essential for conducting clinical trials of pain treatments . Perhaps the most important aspect of a pain measure 's validity is its sensitivity , or ability to detect changes in pain over time and due to treatment . Several factors may affect a measure 's sensitivity , including the complexity of the rating task for the measure , the number of pain intensity levels assessed by the measure , the dimension of pain assessed ( e.g. pain intensity vs. pain relief ) , and the number of individual ratings ( e.g. single rating vs. composite score ) used to create the measure . The purpose of this study was to compare the relative sensitivity of three measures of outcome and a composite made up of all three measures for detecting analgesic effects in two sample s of persons participating in a r and omized controlled trial . One hundred and twenty‐three patients who had undergone knee surgery and 124 women who had undergone a laparotomy were given one of three medications in the day after their surgery : morphine , ketorolac , or placebo . Two measures of pain intensity ( a visual analog scale ( VAS ) and a 4‐point verbal rating scale ( VRS ) ) were administered at baseline , and these measures plus a 5‐point VRS of pain relief were administered at 16 additional time points up to 24 h following surgery . As predicted , we found variability in the sensitivity of the outcome measures used in these studies , with the 4‐point VRS showing less sensitivity than the VAS or relief ratings . However , contrary to our prediction , a composite measure of outcome made up of all three measures was not consistently superior to the individual measures for detecting treatment effects . Finally , we found that pain relief ratings were related to , but also distinct from , change in pain intensity as measured by changes in pain intensity ratings from baseline to each postmedication assessment point . These findings have important implication s for the assessment of pain in clinical trials Background Many HIV/AIDS patients experience pain often due to advanced HIV/AIDS infection and side effects of treatment . In sub-Saharan Africa , pain management for people with HIV/AIDS is suboptimal . With survival extended as a direct consequence of improved access to antiretroviral therapy , the prevalence of HIV/AIDS related pain is increasing . As most care is provided at home , the management of pain requires patient and family involvement . Pain education is an important aspect in the management of pain in HIV/AIDS patients . Studies of the effectiveness of pain education interventions for people with HIV/AIDS have been conducted almost exclusively in western countries . Methods / design A r and omised controlled trial is being conducted at the HIV and palliative care clinics of two public hospitals in Malawi . To be eligible , patient participants must have a diagnosis of HIV/AIDS ( stage III or IV ) . Carer participants must be the individual most involved in the patient ’s unpaid care . Eligible participants are r and omised to either : ( 1 ) a 30-minute face-to-face educational intervention covering pain assessment and management , augmented by a leaflet and follow-up telephone call at two weeks ; or ( 2 ) usual care . Those allocated to the usual care group receive the educational intervention after follow-up assessment s have been conducted ( wait-list control group ) . The primary outcome is pain severity measured by the Brief Pain Inventory . Secondary outcomes are pain interference , patient knowledge of pain management , patient quality of life , carer knowledge of pain management , caregiver motivation and carer quality of life . Follow-up assessment s are conducted eight weeks after r and omisation by palliative care nurses blind to allocation . Discussion This r and omised controlled trial conducted in sub-Saharan Africa among people living with HIV/AIDS and their carers will assess whether a pain education intervention is effective in reducing pain and improving pain management , quality of life and carer motivation . Trial registration Current Controlled Trials IS RCT N72861423 Pain is a ubiquitous phenomenon , but the experience of pain varies considerably from person to person . Advances in underst and ing of the growing number of pathophysiologic mechanisms that underlie the generation of pain and the influence of the brain on the experience of pain led to the investigation of numerous compounds for treating pain . Improved knowledge of the subjective nature of pain , the variations in the measurement of pain , the mind-body placebo effect and the impact of differences in the conduct of a clinical trial on the outcome have changed approaches to design and implement studies . Careful consideration of how these concepts affect the choice of study population , the r and omization and blinding process , the measurement and collection of data , and the analysis and interpretation of results should improve the quality of clinical trials for potential pain therapies . Patients accepting r and omization in a r and omized controlled trial ( RCT ) may not be representative of the clinical population from which they are drawn , calling into question the generalizability of study findings . Comparison of r and omized and non-r and omized inpatient and outpatient sample s at baseline and in treatment outcomes up to one year was made to determine whether the findings of the RCT generalized to non-r and omized patients in the same treatment program . One hundred and twenty one patients with intractable pain , r and omized between inpatient , outpatient and waiting list control , were compared with 128 who elected for either inpatient or outpatient treatment .  Treatment was a group-based multidisciplinary cognitive-behavioral treatment program aim ed at enabling patients to return to more normal function despite persistent pain , delivered to mixed groups of r and omized and elective patients , and outcome was measured by physical performance , pain impact on function , mood , and drug use . Agreement to r and omization was a function of travelling distance from home to hospital . Non-r and omized patients largely resembled their r and omized counterparts before and after treatment . In order to indicate the clinical significance of results , analyses were conducted using numbers needed to treat ( NNTs ) . NNTs estimate the number of patients required in the treatment condition for one of them to achieve the specified outcome who would not have achieved it in the comparison condition . Across a range of measures at one month follow-up , comparison of in patients with out patients gave NNTs between 2.3 and 7.5 , and comparison of in patients with waiting list controls gave NNTs between 2.3 and 3.6 . At one year in patients showed greater likelihood than out patients of maintaining these treatment gains
Presentation of relative effects regarding pain will facilitate interpretation of treatment effects
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 .