Local LBP only, LBP + leg pain above the knee, LBP + leg pain below the knee, and LBP + leg pain and neurological signs had different prognoses, and (2) to determine if this was explained by measured baseline factors.Low back pain (LBP) patients with related leg pain have a more severe profile than those with local LBP and a worse prognosis. Pain location above or below the knee and the presence of neurological signs differentiate patients with different profiles, but knowledge about the prognostic value of these subgroups is sparse. The objectives of this study were (1) to investigate whether subgroups consisting of patients with Routine clinical data were collected during the first visit to an outpatient department and follow-ups were performed after 3 and 12 months. Patients were divided into the four subgroups and associations between subgroups and the outcomes of activity limitation, global perceived effect (GPE) after 3 months, and sick leave after 3 months were tested by means of generalised estimating equations. Models were univariate (I), adjusted for duration (II), and adjusted for all baseline differences (III).Local LBP had the least and LBP + neurological signs the most severe limitations at all time-points, although patients with neurological signs improved the most. Associations with GPE after 3 months were only significant in Model I. Subgroups were associated with sick leave after 3 months in model I and II, with sick leave being most frequent in the subgroup with neurological signs. No significant differences were found in any pairwise comparisons of patients with leg pain above or below the knee.A total of 1,752 patients were included, with a 76% 3-month and 70% 12-month follow-up. Subgroups were associated with activity limitation in all models (p < 0.001). Subgrouping LBP patients, based on pain location and neurological signs, was associated with activity limitation and sick leave, but not with GPE. The presence of neurological signs and pain in the leg both have prognostic implications but whether that leg pain without neurological signs is above or below the knee does not. It is widely believed that the identification of homogeneous subgroups of low back pain (LBP) patients is important for the optimal prediction of prognosis and care ,2. LBP pLBP-related leg pain has been subgrouped into pain above the knee, pain below the knee and leg pain with neurological signs . ClassifDifferentiation between leg pain above and below the knee and leg pain with and without neurological signs were suggested as diagnostic tools more than twenty years ago , but stiThe objective of the current study was to investigate whether the four QTF subgroups were associated with activity limitation after 3 and 12 months, global perceived effect after 3 months, or sick leave at 3 months follow-up in patients referred to a secondary care outpatient department, and whether observed associations could be explained by differences in measured baseline characteristics.The setting and baseline data collection have been previously reported in full detail . In shorAll patients aged 18 years or older who were referred with LBP as their main complaint and were seen in the Department between 10 October 2010 and 30 November 2011 were potential participants. Additional inclusion criteria were that data needed to be available from pain intensity scales, a pain drawing, and from the clinician’s neurological examination in SpineData.Baseline factors were chosen from the health domains of pain, activity limitation, psychology and work participation on the basis of their having evidence of a prognostic association with LBP ,8.Pain items were: duration (months), previous LBP episodes (yes/no), LBP intensity  on present LBP, worst LBP last 14 days and typical LBP last 14 days ), intensActivity limitation was measured with the 23-item Roland Morris Disability Questionnaire (RMDQ)  and calcWork participation was assessed as days on sick leave .Depressive symptoms were measured by the two PRIME-MD 1000 screening questions  using a General health was evaluated using the Euroqol health thermometer (Euroqol VAS) that measures self-reported health status today  .The four subgroups were formed using the following definitions.Local LBP only: The pain drawing only included local LBP, and the worst leg pain intensity in the preceding 14 days was zero .LBP + pain above knee: The pain drawing included pain in the anterior or posterior thigh but no pain in the calf or feet, and the worst leg pain intensity in the last 14 days was one or more .LBP + pain below knee: The pain drawing indicated pain in the calf and/or foot and the worst leg pain intensity in the last 14 days was at least one.(LBP + NRI): The pain drawing included pain below the gluteal folds or the groin, worst leg pain intensity was one or more, and at least one of the following findings was present on the painful side during the clinical examination: muscle weakness, impaired tendon reflexes, altered sensation to touch or pinprick, a straight leg raise test that provoked their familiar leg pain , or a positive prone knee bend test combined with pain to the anterior thigh (Reverse Laségue Test). The term ‘signs of nerve root involvement’ should be considered a label given to patients fulfilling these criteria rather than a definitive diagnostic entity.LBP with signs of nerve root involvement If classification was unclear, for example a patient reporting leg pain intensity to be zero but indicating leg pain on the pain drawing, the patient was excluded from the analysis. Such ambiguous reporting was not necessarily due to inaccurate answers since the intensity scale asked about the last 14 days, whereas patients were asked to indicate ‘where your pain is’ in the pain chart.Activity limitation was measured after 3 and 12 months by the RMDQ and converted to a proportional score .Global perceived effect was scored on a 7-point Likert scale (‘much worse’ to ‘much better’) at 3-month follow-up. This was not repeated after 12 months since self-assessment of effects that are based on recall seem to be problematic if asked about longer-term changes .Sick leave was defined as the proportion of those in the working population at baseline  who reported being on sick leave due to LBP at the time of the 3-month follow-up. Data on sick leave were not available at 12 months.Baseline characteristics were presented as proportions with 95% confidence intervals (95% CI), means with standard deviations (SD), or medians with interquartile ranges (IQR) depending on the data distribution of the variable.local LBP only as the reference category. In addition, absolute subgroup differences at each follow-up time point were tested for statistical significance in generalized linear models. The associations with global perceived effect and sick leave were tested by means of GEE . ‘Success’ on global perceived effect being defined as ‘much better’ or ‘better’ and all other categories as ‘failure’.An association between subgroup and activity limitation was primarily tested in a longitudinal model using population averaged generalised estimating equations (GEE)  which take into account that measures of activity limitation were repeated. The subgroup variable was introduced as a categorical variable in the analysis with dummy variables that had Associations are presented as unadjusted β-values/Odds ratios with 95% CI (Model I). In addition, estimates adjusted for duration of LBP at the first visit (Model II), and adjusted for duration and factors differing between subgroups at baseline (Model III) were calculated. Only covariates with p < 0.1 were kept in Model III with global perceived effect and sick leave as the outcomes because the number of cases was too low to allow for a larger model. Missing values on baseline variables used as covariates were imputed using multiple imputations by five chained iterations . Seventy-five per cent of patients had no missing data, and most imputed variables had less than 10% imputed data. However, 17% were imputed for pain irritability and 10% for self-reported general health.Model I was mainly considered relevant to the setting of the study, since differences in duration between subgroups were regarded to be a consequence of referral patterns to the Department rather than related to the condition. Model II answered whether the four QTF subgroups were associated with outcome, and Model III investigated whether an observed association could be explained by differences in measured baseline characteristics. Episode duration was categorised by being split into 25% quartiles since it had a non-linear relationship with the outcome measures.All analyses were performed using STATA/SE 12.1 using ‘mi’ functions for estimations based on multiple imputations.A total of 2,652 LBP patients above 18 years of age were registered in SpineData within the inclusion period of the study . From these 2,405 fulfilled the inclusion criteria and 1,752  could be classified in the pre-defined subgroups . Patients with LBP + NRI improved more than other subgroups in pairwise comparisons, and the estimated effect of being in the LBP + NRI subgroup on the course of activity limitation was largely unaltered after adjusting for duration and other covariates.Activity limitation from baseline to 12-month follow-up within the four subgroups is illustrated in Figure Local LBP had the least activity limitation at all time points and the LBP + NRI the most .Looking at absolute RMDQ scores, the subgroup with t Figure . PairwisLBP + pain below knee subgroup to 36% in the LBP + NRI subgroup. There were statistically significant associations between the subgroups and global perceived effect in Model I but the prognostic capacity in terms of AUC was low, and the association was not significant when duration was taken into account in Model II . At the 3-months follow-up 29% (95% CI: 25-33%) of these were currently on sick leave, with the distribution in the subgroups ranging from 19% in the Local LBP subgroup to 35% in the LBP + NRI subgroup (p = 0.02). A larger proportion of patients in the LBP + NRI subgroup were on sick leave at 3 months and subgroups were significantly associated with sick leave in model I and model II but not in model III  of the participating patients were in the working population  in the outcome activity limitation at an individual patient level and the predictive ability relating to sick leave was also low when measured by the AUC statistic. It is not uncommon in LBP that prognostic factors show statistically significant associations with outcome at a group level but little predictive value at an individual level  and therHowever, another potentially important result from prognostic research is the treatment implications of subgroup-targeted treatment. Classification tools such as the STarT Back Tool have shown that appropriate matching of treatment pathways to prognostic subgroups can result in better patient outcomes that are also cost-effective . It may In summary, the QTF classification was a prognostic factor at a group level but not very accurate at predicting outcome for individual patients. Therefore this classification should be considered as a factor to be included in multi-factor predictive models, though probably without the distinction of pain above and below the knee. Also, it remains to be investigated whether the QTF classification is a potential treatment effect modifier and its role as a predictor and/or treatment effect modifier may qualify it to be included in multi-dimensional subgrouping tools.The authors have no financial or non-financial competing interests to declare.AK and PK formed the study idea. All authors were involved in the design of the study, interpretation of data, revision of the manuscript, and gave final approval of the manuscript. AK performed the data analysis and wrote the initial draft of the manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/14/171/prepub


Introduction. A five-item Self-Assessment of Treatment (SAT) was developed to assess improvement and satisfaction with treatment associated with the application of a novel high concentration 8% capsaicin topical patch in clinical trials in patients with postherpetic neuralgia (PHN). This study evaluated the item performance and psychometric properties of the SAT. Methods. The SAT, Brief Pain Inventory, SF-36v2, Short-Form McGill Pain Questionnaire, and Patient and Clinician Global Impression of Change  scores were measured in two 12-week Phase 3 clinical trials. Factor analysis assessed the underlying factor structure, followed by examination of the reliability and validity of the multi-item domain. Results. Pooled data from 698 patients completing SAT after 12 weeks of treatment were analyzed. A one-factor model combining three of the five items emerged as the optimal solution. Internal consistency reliability of this treatment efficacy factor was high . Construct validity was demonstrated by moderate to high correlations with change in other study endpoints. SAT mean scores consistently discriminated between patient change groups defined by PGIC and CGIC. Conclusions. The measurement properties of the three-item version of SAT are valid and reliable for assessment of treatment with a high concentration capsaicin patch among patients with PHN. Postherpetic neuralgia (PHN) is a rare and debilitating complication of an acute herpes zoster (shingles) episode and is defined as pain that persists more than three months after the zoster skin lesions (rash) have healed . TypicalFor the past decade, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) have developed consensus reviews and recommendations for improving the design, execution, and interpretation of clinical trials of treatments for pain. At their first meeting in November 2002, agreement was reached on the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatment for chronic pain. The six recommended core domains were: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, 5) symptoms and adverse events, and (6) participant disposition [ symptomsPain relief and patient satisfaction are distinct concepts identified by IMMPACT as central to evaluating treatment of chronic pain. Pain relief measures are used to determine whether the patient has actually benefited from an intervention and provide valuable information on how effectively pain is being managed. In contrast, patient satisfaction measures capture the personal evaluation of the intervention provided . The AmeIn planning the clinical trials for this novel pain treatment, satisfaction surveys in pain were reviewed to evaluate whether an existing instrument could be used in clinical trials to measure the IMMPACT core domain of patient satisfaction. The APS Satisfaction Survey focuses on pain management in general practice, but is not directly related to satisfaction with medication. Another existing survey examined was the Pain Treatment Satisfaction Scale (PTSS) , which mThis lack of a suitable pain satisfaction instrument for use in trials that measure multiple domains of importance to patients supported the development of a new instrument. A recent IMMPACT survey  also ideTherefore, to measure the IMMPACT-recommended domains of participant-reported improvement and satisfaction with treatment and incorporate aspects of daily life, the five-item Self-Assessment of Treatment (SAT) questionnaire was developed for use in the clinical trials evaluating a high concentration 8% capsaicin topical patch . The SATThe primary objective of this study was to evaluate the psychometric properties of the SAT questionnaire as part of the validation of this instrument in patients with moderate to severe neuropathic pain secondary to PHN.2), for the treatment of PHN .This analysis used data collected as part of Studies C116 and C117, two Phase 3 randomized, double-blind, controlled, multicenter clinical trials conducted by NeurogesX to evaluate the efficacy, safety, and tolerability of a high-concentration 8% capsaicin topical patch  score for PHN-associated pain of 3 to 9, inclusive, on a scale of 0 = no pain and 10 = worst possible pain, during the screening period . Exclusion criteria included subjects with other pain conditions  or cognitive impairment that might interfere with judging PHN-related pain or completing pain assessments.2) patches for 12 weeks. Low-concentration capsaicin control patches were used in place of placebo patches to allow for effective blinding of the study, since topical capsaicin can produce a local erythema and a burning sensation. Study C116 included 52 centers in the US, and Study C117 was comprised of 61 study sites in the US and Canada.Patients received either the study medication or low-concentration capsaicin (3.2 mcg/cmThe primary objective of the two PHN studies (C116 and C117) were assessment of capsaicin patch efficacy over 12 weeks. The primary efficacy variable in each clinical trials was the percent change in “average pain for the past 24 hours” NPRS scores from Baseline to Weeks 2–8. The NPRS item is one of many other pain items in the Brief Pain Inventory (BPI). Percent change and proportion of subjects with 30% and 50% decreases in NPRS scores from Baseline to Weeks 2–8 and Weeks 2–12 were key secondary efficacy measures. Other efficacy measures included change in other BPI items, Short-Form McGill Pain Questionnaire (SF-MPQ) pain intensity rating, Medical Outcomes Study Short Form-36 Heath Survey, version 2 (SF-36v2), Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change (CGIC) scores from Baseline to Weeks 4, 8, and/or 12 (when measured at followup) and SAT at Week 12 (end of study).The BPI  providesworst in the last 24 hours; (2) pain at its least in the last 24 hours; (3) pain on average in the last 24 hours (NPRS item); (4) pain right now. An additional question asked subjects to rate the level on interference of their pain with general activity, mood, and other activities of daily living on a scale of 0 (does not interfere) to 10 (completely interferes). Pain interference was assessed in seven areas: (1) general activity; (2) mood; (3) walking ability; (4) normal work (includes both work outside the home and housework); (5) relations with other people; (6) sleep; (7) enjoyment of life.The BPI administered included four questions on pain levels, where subjects were asked to rate their pain on a scale of 0 (no pain) to 10 (worst possible pain) in response to (1) pain at its Data on the “pain now” item was collected at all study visits , Week 4, Week 8, and Termination Visit (Week 12)). Subjects also recorded NPRS scores for “average pain for the past 24 hours” daily in a take-home diary beginning on the evening of the Study Patch Application Visit (Day 0) through the evening before the Week 12 visit.The SF-MPQ  asks subThe SF-36v2 is an assessment of overall health and wellbeing rated in eight areas, including overall health, ability to perform various physical activities, emotional problems, social functioning, vitality, and pain in the previous 4 weeks , 16. ScoThe PGIC and CGIC addressed change in the severity of a patient's illness over a particular time interval. In the C116 and C117 clinical trials, the reference time period was “after receiving study treatment.”patient's impression of change in their condition since admission to the study. The PGIC was completed at all three visits  in Studies C116 and C117, following the Study Patch Application Visit.The PGIC was patient-reported, and asked the subject to “indicate how you feel now, compared to how you felt before receiving treatment in this study” on a 7-point scale of −3 (very much worse), 0 (no change), to +3 (very much improved). This rating scale permitted a global evaluation of the clinician's impression of change in the patient's condition since admission to the study. In Study C117, the CGIC was collected at all study visits after Baseline ; the CGIC was not completed in Study C116.The CGIC was completed by the study investigator, who was asked to compare “how the subject appears to you now, compared to how they appeared to you before receiving treatment in this study” on a 7-point scale of −3 (subject very much worse), 0 (no change), to +3 (subject very much improved). This rating scale permitted a global evaluation of the Subjects were asked to assess capsaicin patch treatment using the SAT questionnaire at the Termination Visit (Week 12). The SAT evaluation form included five questions with three- or five-point response options . The iteFor each question, the subject checked a box on a five-point scale, where the middle option (0) indicated a neutral response and the lower (−2) and higher (+2) options indicated a negative or positive response, respectively. For example, SAT Item 1 asked the patient “How do you assess your pain relief after treatment in this study?” with the response options of “I feel my pain is much worse” (−2), “somewhat worse” (−1), “no better and no worse” (0), “somewhat better” (1), and “much better” (2). In Study C116, Question 4 “Would you undergo this treatment again?” was administered to subjects with only three response options: “No, absolutely not” (−2), “Unsure” (0), and “Yes, definitely” (2).Post hoc analyses of the SAT and other PROs were performed on the intent-to-treat (ITT) population, which included all subjects enrolled in the C116 or C117 studies who were randomized, received the study drug, and had at least three days of nonmissing “average pain for the past 24 hours” NPRS scores for the calculation of the Baseline NPRS score. The analyses incorporated the patient population for whom Termination Visit (Week 12) data were available, as this was the only time in both studies that SAT data were collected. The schedule of visits and study measures used in this analysis are summarized in The psychometric analyses focused on the factor structure, reliability, and validity of the SAT in the C116 and C117 datasets. Psychometric properties of the SAT were first assessed using data from Study C116; replicability of the results for SAT psychometric properties was investigated using data from Study C117. Results from analyses using the pooled samples are presented herein, given the representativeness of this larger dataset and the replicated psychometric properties demonstrated by each individual study. SAS statistical software version 9.2  and MPlus version 5.21  were used to conduct the analyses. All statistical tests were two-sided and used a significance level of 0.05 unless otherwise noted.For the SF-MPQ and SF-36v2, missing data were handled per the instrument developer's scoring instructions. NPRS scores for average pain in the last 24 hours were based on a daily take-home diary; baseline and Week 12 scores were computed as the average NPRS pain rating for 7 days prior to the visit. Observed data were used for analyses, with no additional imputations for missing data unless otherwise specified. As part of the exploratory nature of the analyses of the SAT's measurement properties, individual SAT items were analyzed separately, and composite subscale scores were generated. Two subscales informed by the confirmatory factor analysis (CFA) results were evaluated, reflecting items relating to treatment success  and treatment satisfaction (SAT Items 4 and 5) computed as the arithmetic average of respective items' responses scores .Descriptive statistics , minimum, and maximum for continuous variables and frequencies for categorical variables) for patients in the pooled sample were reported. Age, gender, race/ethnicity, height, and weight were evaluated at screening. Descriptive statistics  for PRO subscale and component scores were examined for the overall sample. PRO measures included NPRS “pain now” and “average pain in the last 24 hours” ratings at screening and baseline (Week 0), average scores for the subscales of the SF-36v2 and SF-MPQ pain intensity at screening, BPI pain scores and composite pain interference scores at screening, SAT items and subscales, PGIC for Studies C116 and C117, and CGIC for Study C117 at Week 12.After examining the Spearman inter-item correlations to assess the extent to which the five SAT items correlated with each other, an exploratory factor analysis (EFA) and a CFA using a structural equation modeling (SEM) approach was conducted to evaluate the factor  structure of the SAT and fit of the items within the hypothesized scale. The EFA and CFA were performed using the five items comprising the SAT at Week 12. In the SEM approach, parameter estimates were generated based on analysis of the actual covariance matrices representing the relationships among SAT items and the estimated covariance matrices of the measurement model. Measurement models for one and two domains were developed, with each item loading on its respective scale. In addition, factor solutions with eigenvalues near or greater than 1.0 were examined, as well as the amount of variance accounted for by the resulting factor structure. The overall fit of each model was assessed, as well as the magnitude of the item factor loadings.In the CFA analyses, several fit statistics were used to provide information about the adequacy of the model to explain the data. In general, the model was considered to explain the data well if the comparative fit index (CFI) was ≥0.90. The standardized root mean residual (SRMR) measures the mean absolute difference between the observed and model-implied correlations; values <0.1 were considered acceptable . FinallyInternal consistency reliability is a measure of the consistency of results across individual items on the same instrument. Internal consistency reliability of the SAT was evaluated using Cronbach's alpha  to calcuConstruct validity refers to the extent to which the instrument measures what it is intended to measure . ConstruThe ability of the SAT items and composite and subscale scores to discriminate between groups of patients according to levels and changes of symptom severity was also evaluated. Discriminant or known-groups validity was assessed using analysis of variance (ANOVA). These analyses provided a test of whether there were significant differences in mean SAT scores for different amounts of change based on other PRO measures. The ANOVAs were performed comparing mean SAT items and composite and subscale scores for the relevant time points and by groups defined by the following variables: (1) patient- and clinician-reported change groups created by PGIC and CGIC using the seven levels of change, and (2) high (NPRS ≥ 7) and lower (NPRS < 7) pain patients at baseline .To evaluate concurrent validity of the SAT, all items and the composite and subscale scores were used. According to the SAT responses, three response levels were created: (1) patients who improved ; (2) patients with no change ; (3) patients who worsened . NPRS and other BPI item change scores were compared by SAT response groups using ANOVA models; average change scores from baseline to Week 12 in the pain reported by the NPRS pain now and average 24-hour pain and from screening to Week 12 for BPI worst and least pain items were evaluated.N = 349) and C117 (N = 349) were included in the current SAT analyses. Patient characteristics  for the patient population pooled across the two trials were similar between treatment groups , while their bivariate relationships with Items 4 and 5 were weaker, ranging from 0.35 to 0.60 (P < 0.0001). There was a moderate correlation between Items 4 and 5 .Spearman inter-item correlations assessed the extent to which the five items of the SAT correlated with each other and with the composite scores (data not shown). Items 1 (pain relief), 2 (activity level), and 3  were strongly correlated with each other, and moderately correlated with Items 4 (undergo treatment again) and 5 (compared to previous treatment). Correlations among the first three items ranged from 0.67 to 0.77  to evaluate item loadings and overall model fit . Factor Exploratory one- and two-factor models were evaluated to determine the factor structure of the SAT . The oneA two-factor exploratory model was also specified to evaluate the tenability of extracting a second factor . Eigenvaχ2(df = 5) = 92.83, P < 0.0001). Model fit statistics showed good fit (CFI = 0.95) and relatively low residuals (SRMR = 0.048); RMSEA suggested a slightly worse fit .Based on the EFA results, confirmatory models were performed to formally test the one- and two-factor structures . In the χ2(df = 4) =29.19, P < 0.0001). Model fit was very good (CFI = 0.99) with small residuals , indicating that the model adequately explained the data; RMSEA suggested a slightly worse fit than other fit indices. Loadings for the prespecified factor structure were generally large and consistent with the EFA results. Factor loadings for SAT Items 1, 2, and 3 with Factor 1 were 0.82, 0.85, and 0.93, respectively, and 0.59 for SAT Item 4 and 0.84 for SAT Item 5 on the second factor. Although the two factors were strongly correlated (r = 0.75), this two-factor solution created the best structure for interpretable SAT composite scale scores.In the second model, SAT Items 1, 2, and 3 were specified as loading on the first factor, and SAT Items 4 and 5 as loading on the second factor. The chi-square test of model fit for the two-factor CFA was significant . The SAT subscale comprised only of SAT Items 1 to 3  evaluating treatment effectiveness had excellent reliability, with an alpha of 0.89. A separate subscale made up of SAT Items 4 and 5  evaluating treatment satisfaction had an alpha of 0.66.Construct validity of the SAT was assessed by examining relationships between SAT items and subscale scores with conceptually-related outcome measures using Spearman correlation coefficients . OutcomeP < 0.0001). In Study C117, correlations with CGIC ranged from 0.48 to 0.85 . SAT Item 1 (pain relief) was the most strongly related to PGIC  and CGIC . Correlations between SAT Item 4 (undergo treatment again) with PGIC  and CGIC  were quite smaller, although moderate in magnitude and statistically significant.Moderate to large positive correlations were observed between SAT items and scores and PGIC and CGIC (Study C117 only) at Week 12 . These pr = 0.89, P < 0.0001) and clinician  assessments. The two-item subscale made up of SAT Items 4 and 5 was more weakly related to PGIC  and CGIC .Among SAT composite scale scores, the three-item subscale comprised of pain relief, activity level, and quality of life had the largest correlations with patient (P < 0.0001). Changes in BPI pain at worst  and at least  in the last 24 hours and SF-MPQ present pain intensity scores  showed a similar range of correlations with SAT items. As expected, SAT pain relief (Item 1) consistently showed the strongest relationships with pain change scores. Associations between SAT activity level (Item 2) and quality of life (Item 3) with changes in pain were slightly smaller. The weakest relationships were found with SAT items related to treatment satisfaction (Items 4 and 5). Weaker associations were observed between SAT items and changes in BPI pain interference with general activity, mood, and other activities of daily living and SF-MPQ pain intensity ratings for sensory and affective descriptors (data not shown). The majority of these correlations were small, with none larger in magnitude than −0.40.Overall, SAT was moderately correlated with changes in pain-related outcomes . StatistAmong the SAT composite scale scores, the treatment effect subscale  showed stronger relationships with changes in pain based on NPRS, BPI, and SF-MPQ items than the two-item treatment satisfaction subscale.r = 0.27 to 0.43, all P < 0.0001) than physical functioning  or vitality  subscales. Also, correlations between SAT treatment effect items  and changes in health status were consistently larger than with SAT items related to satisfaction . A similar pattern was obtained for SAT subscale scores with changes in SF-36v2 health status domains.SAT items were more related to SF-36v2 bodily pain  and low (NPRS < 7) pain groups.P < 0.0001).Significant differences in mean SAT items and scores between change groups based on PGIC and CGIC were identified. Results demonstrate an overall pattern of average SAT scores that differ as a function of response levels for global assessments of change . SAT shot-test comparisons, patients with less pain at Baseline had significantly higher scores than those with high pain on SAT Items 1 , 2 , and 3 .Some SAT scores showed evidence of ability to discriminate between patient pain level groups based on NPRS pain at Baseline . Mean SAConcurrent validity of SAT items and scores was evaluated using ANOVA models comparing average change scores from Baseline to Week 12 in pain reported by the NPRS pain now and average 24-hour pain, and Screening to Week 12 for BPI worst and least pain items by SAT response levels .P < 0.0001).The degree of change in NPRS scores between Baseline and Week 12 of the study concurred with the classification into change groups based on SAT scores . NegativP < 0.0001).Change in pain based on BPI pain at its worst and pain at its least also reflected differences based on SAT response levels . MagnituBecause the value and importance of therapeutic changes differ greatly among participants, as well as between patients and their clinicians , it is eThe SAT was designed for use in clinical trials to assess the IMMPACT-recommended domain of improvement of patients with PHN and their satisfaction with treatment using a high concentration 8% capsaicin patch. Psychometric properties of the SAT examined in this study demonstrated that the first three items assessing improvement of pain relief, activity level, and quality of life had a strong factor structure, high internal consistency reliability, and moderate to strong construct validity with change in other study endpoints. Moreover, the three-item SAT scores consistently discriminated between patient change groups defined by the PGIC response categories in both studies and the CGIC responses used in Study C117. Two additional SAT items querying whether patients would undergo the treatment again and how the study treatment compares to previous medication or therapies for the patient's pain did not demonstrate a strong structural relationship with the other three items, although both are key components to understanding satisfaction with this treatment. These two items assess important treatment-related concepts for patients who must determine whether the positive attributes of a treatment outweigh any potential side effects; this determination is key in understanding whether current and future patients will adhere to and continue with treatment .To provide useful and valid information, a satisfaction subscale needs to be reliable and valid, and should capture a meaningful concept. In this case, the measurement properties were weaker for the two-item satisfaction subscale in terms of internal consistency reliability and known-groups validity. The satisfaction subscale had lower construct and concurrent validity, and was also less responsiveness in detecting change. Moreover, although the factor analysis supported a two-factor solution, the magnitude of the second factor's loading did not support a clear and distinct concept.Despite the favorable psychometric results displayed by the five SAT items—and specifically the three-item treatment effects scale—there are several limitations to these SAT items. First, the patient's response to the SAT items requires a 12-week retrospective assessment by the patient, requiring each to somehow remember their condition  before initiating treatment, and to mentally subtract this assessment from their current state to select the most appropriate response . These rAlthough there is no publication describing the instrument development process for the SAT, these items assess key areas of treatment change  recommended by IMMPACT  and are The ability of the SAT questionnaire to measure improvements and satisfaction with treatment in PHN clinical trials was psychometrically evaluated, with recommendations for future use.


P = 0.64), treatment for nausea (P = 0.21), pruritus (P = 0.39), emesis (P = 0.35), or patient satisfaction (P = 0.29). There were no differences in pain and nausea scores over the measured time periods . In parturients receiving ITM for elective CD, IIIH block offers no additional postoperative benefit for up to 48 hours.The ilioinguinal-iliohypogastric (IIIH) block is frequently used as multimodal analgesia for lower abdominal surgeries. The aim of this study is to compare the efficacy of IIIH block using ultrasound visualization for reducing postoperative pain after caesarean delivery (CD) in patients receiving intrathecal morphine (ITM) under spinal anesthesia. Participants were randomly assigned to 1 of 3 treatment groups for the bilateral IIIH block: Group A = 10 mL of 0.5% bupivacaine, Group B = 10 mL of 0.5% bupivacaine on one side and 10 mL of a normal saline (NSS) placebo block on the opposite side, and Group C = 10 mL of NSS placebo per side. Pain and nausea scores, treatment for pain and nausea, and patient satisfaction were recorded for 48 hours after CD. No differences were noted with respect to pain scores or treatment for pain over the 48 hours. There were no differences to the presence of nausea ( The ilioinguinal and iliohypogastric (IIIH) block can be used as part of a multimodal analgesic regimen for postoperative pain in patients undergoing lower abdominal and inguinal surgeries –3, incluIn patients undergoing elective caesarean delivery (CD) under spinal anesthesia, intrathecal morphine (ITM) is routinely given to provide postoperative analgesia for up to 24 hours. However, a known side effect of ITM is pruritus with only a moderate reduction in pain scores and a modest increase in patient satisfaction. This study investigates if the supplemental use of the bilateral IIIH block given after spinal anesthesia with ITM can reduce postoperative pain for up to 48 hours after surgery.After local Institutional Review Board (IRB) approval and informed verbal and written consent, 51 study participants were planned to be enrolled . Parturients were eligible if they were having an elective CD with a low transverse incision under spinal anesthesia, were American Society of Anesthesiologists physical status 1 or 2, and had a singleton fetus >37 weeks of gestation. Parturients requiring an emergent caesarean delivery for maternal and/or fetal distress, and parturients with preeclampsia, eclampsia, history of substance abuse, progressive neurologic disease, infection at insertion site, or allergy to local anesthetics and narcotics were ineligible to participate in the study. μg). Intrathecal morphine was given to provide postoperative analgesia for up to 24 hours while intrathecal fentanyl was added to supplement the spinal block. Women were randomly assigned using a computer generated table to 1 of 3 treatment groups for IIIH block after CD: Group A = 10 mL of 0.5% bilateral bupivacaine IIIH Block, Group B = 10 mL of 0.5% bupivacaine IIIH block on one side and 10 mL of a normal saline (NSS) placebo block on the opposite side , and Group C = 10 mL of bilateral NSS placebo block. Study parturients received a standard spinal anesthetic comprising 0.75% hyperbaric bupivacaine (12 mg) plus morphine (0.15–0.2 mg) and fentanyl (10–20 The patient and anesthesia block provider (MV) were blinded to all study medications. After completion of surgery and cesarean delivery, all groups underwent bilateral US guided IIIH blocks in the postanesthesia care unit (PACU) while still under the affects of the spinal anesthetic. Using an aseptic technique, bilateral US blocks were performed with the patient supine with a 3–5 MHz Multilinear US Probe-A connected to an S-Nerve ultrasound machine  was measured on a 0 to 10 scale (0 = no pain/nausea and 10 = worst possible pain/nausea). Pain with ambulation was also assessed using the VRS when initiated by the patient. Data was collected at hourly intervals until PACU discharge, then every 4 hours while awake for the first 24 hours after surgery, and then every 8 hours while awake during the second day (48 hours). The study concluded 48 hours after surgery at which time patient satisfaction regarding postoperative pain control was assessed . Additional data collected included demographic, blood pressure, heart rate, respiratory rate, temperature, time of first ambulation, and supplemental narcotic requirement and dosage as per standard postcaesarean delivery protocol at our institution. Standard post-CD analgesic protocol at our institution is to provide ITM in the spinal anesthetic, followed by intravenous (IV) ketorolac (30 mg) every six hours for the first postoperative day followed by oral (po) pain medications  per patient preference. In order to compare the different types of postoperative pain medications used as part of our postoperative CD protocol, opioids were converted to morphine equivalents [P ≤ 0.05 is considered significant in the overall three group comparison tests, while all post hoc simultaneous intergroup comparisons are considered significant at P ≤ 0.02 to adjust for the multiple comparisons. Repeated measurements for pain scores, nausea scores, and patient satisfaction were analyzed using MANOVA. Nausea treatment was recorded binomially (yes/no) throughout the 48 hour observation. Group differences for nausea treatment were analyzed using chi-square. The study was powered to detect a mean difference of 3.0 in pain VRS between the control Group C and the bilateral block Group A. Assuming an equal standard deviation of 2.7 on the VRS scale, 17 patients are required per group to maintain 80% power and a 0.05 error rate. The process of enrolling, allocating, and analyzing the sample size is presented in Fifty-one patients were enrolled in the study. One patient was excluded due to study logistical data information which could not be collected due to multiple emergencies occurring in the labor and delivery suite .  No differences were noted with respect to demographic data , spinal block medications , surgical operative time, time spent in PACU, time to first ambulation, and overall patient satisfaction score . P = 0.64), treatment for nausea (P = 0.21), pruritus (P = 0.39), emesis (P = 0.35), and patient satisfaction (P = 0.29) among the three groups.No differences were noted with respect to median pain scores over the measured time periods  or postoP > 0.05). Proportional hazards survival analysis for time to first nausea treatment was also nonsignificant (P = 0.34).MANOVA showed no differences with respect to pain and nausea over the various measured time periods measured from PACU to 48 hours postsurgery  compared to a placebo block for up to 48 hours in patients receiving preoperative ITM. We found that the IIIH block with ITM does not improve postoperative analgesia nor decrease opioid side effects such as nausea, vomiting, and pruritus for up to 48 hours post CD.The ilioinguinal-iliohypogastric block (IIIH) is commonly used as a part of multimodal analgesia for lower abdominal, inguinal, and pediatric surgeries . Aasbø eThe ilioinguinal nerve arises from the first lumbar nerve and emerges from the lateral border of the psoas major just below the iliohypogastric nerve, passes obliquely across the quadratus lumborum and iliacus, perforates the transverse muscle above the iliac crest, and communicates with the iliohypogastric nerve between the transverse and internal oblique muscles . The posThe post-operative analgesic benefits of US-guided IIIH blocks have been demonstrated in CD , 5. BellThis study may have benefited with a control arm without the use of ITM. However, since ITM is considered the “standard of care” for CD under spinal anesthesia, we elected not to use a control arm without ITM but use a control group with a placebo block in keeping with current practice. Furthermore, multiple studies have determined that the use of ITM with the TAP offered no additional advantages, and we wished to determine if the IIIH block would be efficacious. Another limitation is that all patients got a standardized postoperative analgesic regimen consisting of intravenous ketorolac for the first 24 hours followed by oral pain medications for the next day. Patients were offered these medications regardless of their VRS pain score. We are unaware of any double blind, randomized controlled trial managing PONV, and postoperative CD pain using US-guided IIIH block as part of a multimodal postoperative analgesia. In conclusion, the IIIH block under ultrasound guidance does not improve postoperative analgesia or decrease opioid side effects such as nausea, vomiting, and pruritus in patients receiving spinal anesthesia with ITM for CD.


Low back pain (LBP) is common and costly. Development of accurate and efficacious methods of diagnosis and treatment has been identified as a research priority. A diagnosis-based clinical decision guide  has been proposed which attempts to provide the clinician with a systematic, evidence-based means to apply the biopsychosocial model of care. The approach is based on three questions of diagnosis. The purpose of this study is to present the prevalence of findings using the DBCDG in consecutive patients with LBP.Demographic, diagnostic and baseline outcome measure data were gathered on a cohort of LBP patients examined by one of three examiners trained in the application of the DBCDG.Data were gathered on 264 patients. Signs of visceral disease or potentially serious illness were found in 2.7%. Centralization signs were found in 41%, lumbar and sacroiliac segmental signs in 23% and 27%, respectively and radicular signs were found in 24%. Clinically relevant myofascial signs were diagnosed in 10%. Dynamic instability was diagnosed in 63%, fear beliefs in 40%, central pain hypersensitivity in 5%, passive coping in 3% and depression in 3%.The DBCDG can be applied in a busy private practice environment. Further studies are needed to investigate clinically relevant means to identify central pain hypersensitivity, poor coping and depression, correlations and patterns among the diagnostic components of the DBCDG as well as inter-examiner reliability and efficacy of treatment based on the DBCDG. Low back pain (LBP) affects approximately 80% of adults at some time in life  and occuOne of the reasons often given for the meager benefits that have been found with various LBP treatments is that these treatments are generally applied generically, without regard for specific characteristics of each patient, whereas the LBP population is a heterogeneous group, requiring individualized care . DevelopIn recent years there has been a movement away from the biomedical model for understanding the LBP experience toward a biopsychosocial model -15. ThatA diagnosis-based clinical decision guide (DBCDG) has been proposed for the purpose of guiding clinicians in applying biopsychosocial concepts to the diagnosis and management of patients with LBP . This haCohort studies documenting the outcome of treatment of subsets of LBP patients have been published and the results appear promising -20. HoweThe study protocol was approved by the Institutional Review Board of New York Chiropractic College (protocol #09-04). It was also reviewed by the Health Insurance Portability and Accountability Act (HIPAA) compliance officer of the facility at which the data were gathered and was deemed to be in compliance with HIPAA regulations. All subjects signed informed consent forms, agreeing to have their data included in the study.Data were gathered prospectively in consecutive patients seen at the Rhode Island Spine Center between 2/7/08 and 2/26/09.Patients were included in the study if they 1) had LBP  were age 18 years or older; 3) provided informed consent; 4) were able to communicate well in English; 5) had a Bournemouth Disability Questionnaire (BDQ) score of 15 or higher.All examinations were carried out by one of two chiropractic physicians, one with over 20 years experience and the other with over 9 years experience, or by a physical therapist with over 10 years experience. All had a minimum of 50 hours of postgraduate training in the McKenzie method. The physical therapist also had 80 hours of postgraduate training in manual therapy. Several discussions between the examiners took place over the course of five years prior to commencing data gathering on the application of the DBCDG. This occurred in the form of monthly clinical meetings in which the application of the DBCDG in particular patients was discussed as well as recent developments in the literature related to the evaluation and management of patients with LBP. History and examination were performed according to the usual course of patient care at the Rhode Island Spine Center.Details of the DBCDG are published elsewhere ,17 but t1. Are the symptoms with which the patient is presenting reflective of a visceral disorder or a serious or potentially life-threatening disease?The purpose of this question is to identify signs and symptoms suggestive of non-musculoskeletal problems for which LBP may be among the initial symptoms. Gastrointestinal and genitourinary disorders are included in addition to such "red flag" disorders as infection and malignancy.2. From where is the patient's pain arising?With this question the clinician investigates distinguishable characteristics of the pain that may allow treatment decisions to be made. In most cases, the exact tissue of origin cannot be unequivocally determined, however several studies have found that patients can be distinguished based on historical and examination characteristics -27 and t3. What has gone wrong with this person as a whole that would cause the pain experience to develop and persist?With this question the clinician attempts to identify factors that may serve to perpetuate the ongoing pain experience. These factors may involve somatic, neurophysiologic or psychological processes .Following each new patient encounter the answers to the three questions of diagnosis were documented on a standardized form  standard history and examination procedures were used. In cases in which it was warranted, special tests such as radiographs, MRI or blood tests were ordered.In seeking answers to the second question of diagnosis (source of the pain), four signs were considered ,17:1. Centralization signs, detected through historical factors that are associated with disc pain  and by u2. Segmental pain provocation signs, detected through historical factors that are associated with lumbar facet or sacroiliac pain  and thro3. Neurodynamic signs, detected through historical factors associated with radiculopathy and neurodynamic tests designed to provoke nerve root pain -34.4. Myofascial signs, detected through palpation of myofascial tissues . These sIn seeking answers to the third question of diagnosis (perpetuating factors), three factors were considered :1. Dynamic instability, detected through clinical tests of motor control for the lumbopelvic spine -43.2. Central pain hypersensitivity, detected through observation of pain behavior in response to stimuli as well as through Waddell's nonorganic signs . A thres3. Psychological factors. Fear beliefs were measured using the 11-item Tampa Scale for Kinesiophobia (TSK) . A scoreEach patient completed the full BDQ  and the Treatment was left to the discretion of the primary treating clinician based on the diagnosis, and in general a "team approach" was taken. In the context of the DBCDG, these are the treatments that were applied:In response to the findings or the second question of diagnosis (source of the pain):Centralization signs: End range loading maneuvers in the direction that produced centralization . BecauseSegmental pain provocation signs: As joint manipulation has been shown to have both neurological  and biomNeurodynamic signs: In the acute stage, anti-inflammatory measures were pursued via referral. This was in the form of non-steroidal anti-inflammatory medications, oral steroids or epidural steroid injections , dependiMyofascial signs: Myofascial therapies such as ischemic compression and post-isometric relaxation  were useIn response to the third question of diagnosis (perpetuating factors):Dynamic instability: Patients diagnosed with dynamic instability were treated with stabilization exercise ,62.Central pain hypersensitivity: Education was provided regarding the nature of pain for the purpose of helping the patient understand that the intensity of pain was not related to extensive "tissue damage" ,64. In aFear, catastrophizing, passive coping, depression, poor self-efficacy: Education was provided for the purpose of correcting misperceptions regarding the nature of pain . In addiThe treatment algorithm can be found in Figure Descriptive statistics were used to characterize the study population. Frequencies, percentages, and 95% confidence intervals were computed for categorical variables; means, standard deviations, medians, and ranges were computed for continuous variables. Data management and statistical analyses were conducted with Microsoft Excel and SAS .Data were gathered on 264 patients, 63% of whom were female. The mean BDQ score was 40 and the mean pain intensity was 7/10. Baseline characteristics are presented in Table Regarding the first question of diagnosis , 2.7% of patients were positive. Data regarding the second (source of the pain) and third (perpetuating factors) questions of diagnosis are provided in tables In recent years, spending on the diagnosis and management of patients with LBP has dramatically increased, yet this has not resulted in improved outcomes in terms of patient suffering and disability rates . As suchCentralization signs were found in 41% of patients. This is similar but slightly lower than the 45-50% prevalence of this sign found in other studies of patients with LBP ,69,70. IThe prevalence of segmental signs involving the SI joint was 27%. This is similar to the 31% reported by DePalma, et al  but subsThere were three factors under the third question of diagnosis (perpetuating factors) for which the prevalence was quite low. Only 5% of patients were identified to have central pain hypersensitivity and only 3% were identified to have each of passive coping and depression. As these factors have been found to be significant in the development of chronic LBP -80, it istrategies and depression. Other important psychological factors that are of importance in patients with LBP, such as catastrophizing , poor seThis study had several limitations. First, the sample size was only 264 patients. A larger sample would have increased the study's scientific rigor. In addition, all data were gathered at a single clinic and thus it is not known whether the information is generalizable. Also the design was observational and the practitioners were not blinded to the findings on each patient. Finally, because this was a pragmatic study in which data were gathered during the normal course of clinical care detailed information regarding psychological factors was not obtained as this would have required patients to fill out several questionnaires. On the other hand, the fact that this study was carried out in a real-world environment may be a strength, in that it suggests that the information applies to the environment in which patients are most commonly cared for as opposed to the controlled environment of a research center.Future studies will seek to determine correlations and patterns among the various diagnostic factors, the utility of the coping strategies and depression questions that were used, the inter-examiner reliability of the diagnostic strategy, and ultimately efficacy of the approach. Preliminary data suggests that outcomes in select patients groups may be favorable -20,93, bThe DBCDG can be applied in a private practice setting. It appears that patients with LBP can be distinguished on the basis of the findings of this approach, and treatment plans can be formulated based on the diagnosis by utilizing this strategy. Future research is needed to investigate the validity of the questions used in this study to identify problematic coping strategies and depression and to seek improved means of identifying central pain hypersensitivity. Further research is also needed to investigate correlations between the diagnostic findings, reliability of the diagnoses and efficacy of treatment based on the DBCDG.The authors declare that they have no competing interests.DRM originally conceived of the study and served as an examiner. He was also the main writer of the manuscript. ELH was responsible for statistical analysis and writing and editing the manuscript. Both authors read and approved the final manuscript.Standardized form on which the answers to the three questions of diagnosis were documented.Click here for file


Pain is a clinically significant symptom in children with JIA. The patients at our outpatient clinic rarely spontaneously report pain as an obstacle for functional ability.To systematically screen for pain and functional disability due to pain in patients with JIA aged10-19.All patients aged 10-19, visiting the Paediatric Rheumatology outpatient clinic at Skane University Hospital, Lund, Sweden, in February to April 2010 were asked about presence of pain and how pain affected their functional capability.Pain was measured with Visual Analogue Scale (VAS), 0-100 mm.Impact of pain on functional capability in daily life was measured with Functional Disability Inventory (FDI). FDI consists of fifteen questions and a score is calculated where 0 indicates no, and 60 maximum impact on functional capability.A total of 139 patients took part in the survey. Seventy-five of those had JIA, 45 girls and 30 boys. The results from this JIA-group are reported in this abstract.The mean age of the patients was 15 years (range 10-19). Median pain measured on a VAS was 7 mm (range 0 to 84). 65% of the patients estimated pain between 0 and 25 mm on VAS. 23 patients (31%) reported no pain (VAS=0).The mean value for FDI was 3 (range 0-22).The two items in the FDI, which were scored highest, were participation in gymnastic lessons and to run 100 meters.A majority of the patients with JIA reports a low grade of pain, less than 25 mm on VAS 0-100 mm. Thirty-one percent of patients report no pain at all. This indicates a lower prevalence of pain as compared to other reports.Taking part in physical activities seems to bee the area which is most affected by pain, according to FDI. Further studies should focus on factors that might influence the perception of pain in JIA such as subtype of disease, disease duration, age or gender.


Although back complaints are common among older people, limited information is available in the literature about the clinical course of back pain in older people and the identification of older persons at risk for the transition from acute back complaints to chronic back pain.The aim of this study is to assess the course of back complaints and identify prognostic factors for the transition from acute back complaints to chronic back complaints in older people who visit a primary health care physician.The design is a prospective cohort study with one-year follow-up. There will be no interference with usual care. Patients older than 55 years who consult a primary health care physician with a new episode of back complaints will be included in this study.Data will be collected using a questionnaire, physical examination and X-ray at baseline, and follow-up questionnaires after 6 weeks and 3, 6, 9 and 12 months.The study 'Back Complaints in the Elders' (BACE) will take place in different countries: starting in the Netherlands, Brazil and Australia. The research groups collaborate in the BACE consortium. The design and basic objectives of the study will be the same across the studies.This consortium is a collaboration between different research groups, aiming to provide insight into the course of back complaints in older people and to identify prognostic factors for the transition from acute back complaints to chronic back complaints in older persons. The BACE consortium allows to investigate differences between older people with back complaints and the health care systems in the different countries and to increase the statistical power by enabling meta-analyses using the individual patient data. Additional research groups worldwide are invited to join the BACE consortium. Back pain is the most common musculoskeletal complaint seen in primary care. A systematic review of prevalence studies on low back pain found a point prevalence ranging from 12% to 33% . The mosAlthough there are reports on the course of acute or subacute back complaints, few studies distinguished between younger adults and older persons -12. EvenIt is important to assess the course of back complaints in older adults, because older age is frequently reported as a prognostic factor for the transition from acute back complaints to chronic back complaints . This maIf patients seek medical care for their back complaints, this usually takes place in a primary care setting. The GP evaluates the patient and decides whether further diagnostics and referral to secondary care or other health care providers are required. The diagnostics are, as recommended by several guidelines, mostly based on the presence of the 'red flags' as indicators of possible underlying pathology . HoweverThis cohort study will be set-up and conducted in different countries. Therefore, we established the BACE consortium to standardize methods regarding eligible patients and measurements. The consortium will allow us to compare the course and prognostic factors of back pain across different countries, and investigate the influence of healthcare systems on the treatment of back complaints. Meta-analysis using individual patient data will lead to more precise estimates of associations and opens the possibility to study outcomes in pre-defined subgroups of older patients with back pain.The primary objectives of the cohort study are:1) To determine the duration, severity and clinical course of back pain in older people who visit the GP with a new episode of back pain.2) To identify possible prognostic factors for the transition from acute back complaints to chronic back complaints in older people.Secondary objectives are:1) To determine the level of functional disability, quality of life and productivity loss present in older people visiting their GP with back pain.2) To establish the diagnostic value of the 'red flags' examined at baseline.3) To determine the prevalence and prognostic value of the separate signs of vertebral degeneration and osteoporotic fractures in older people with back pain.4) To determine the prevalence of underlying pathology  identified by the GP, in older people with back pain.5) To determine the medical consumption of older people with back complaints, visiting their GP.Additional objectives BACE consortium:1) To identify differences regarding the course and prognostic factors of older people with back complaints visiting a GP in the different countries joining the BACE consortium.2) To determine the impact of the different healthcare systems on the management of back complaints in older people.3) To determine if prognostic factors found by national BACE studies can be validated in the BACE consortium.4) To determine if meta-analysis using individual patient data of the different BACE studies leads to more precise estimates of associations.5) To identify subgroups of older people with back complaints.This study will be a prospective cohort study with a follow-up period of one year. Data will be collected using questionnaires, physical examinations and X-ray examination. This study will be observational, meaning that there will be no interference with the care given by the GP or other healthcare providers with respect to advice, diagnostics or treatment. Before starting the study, the research protocol needs to be approved by the appropriate ethics committee of the different research groups joining the BACE consortium. This protocol has already received ethical approval from the Medical Ethics Committee of the Erasmus Medical Center, the Netherlands and the Ethic Committee in Research of Federal University of Minas Gerais, Brazil. Figure Patients aged >55 years will be included in the BACE cohort when they consult a GP for a new episode of back complaints. All back complaints, defined as pain in the region from the top of the shoulder blades to the first sacral vertebra, will be included. An episode is considered 'new' if the patient has not visited a G P during the preceding 6 months for the same back complaint.Patients who are unable to fill in the questionnaires as a result of language problems or a cognitive disorder will be excluded from the study, as are patients unable to undergo the physical examination (e.g. wheelchair-bound patients). An anonymous record will be kept of the number of patients who choose not to participate, as well as the number of the excluded patients and the reason for exclusion.Participating GPs will be asked to refer all patients with a new episode of back pain, aged >55 years, to the BACE study. They will inform patients either during consultation or in writing within 2 weeks of their consultation. The GP will ask for the patient's permission to sent his/her contact information to the researchers. The researchers will contact the patients, answer any questions of the patient and make an appointment for the physical examination of those who verbally consent to participate. The informed consent procedure will be completed during the physical examination. The appointment for the X-ray examination will be made after the physical examination.A standardized protocol for the physical examinations has been developed by the researcher (JS) and two senior researchers with ≥ 10 years of experiences in both physiotherapy and research (SB-Z and PL). Trained research assistants will conduct the physical examination. Standardization of the examinations among the research assistants will be accomplished by a series of training sessions before commencing recruitment and will be repeated during the recruitment period. An instruction video and protocol will be available to ensure standardization between the different research groups joining the BACE consortium. The physical examination will be conducted as close to the GP consultation date as possible. During the physical examination some of the red flags will be measured. Other red flags will be assessed in the baseline questionnaire. Recorded red flags are based on the literature -23 and aThe examination will consist of the following parts: 1) history taking e.g. pain location, severity of the pain, radiation of the pain and history of back pain, 2) inspection of the body e.g. palpation, neuropathic pain diagnostic questionnaire (DN4), ankle tendon reflex, knee tendon reflex and hypesthesia or hypalgesia of the foot and toes, 3) range of motion and additional diagnostic tests, e.g. test of Lasègue, finger-floor distance, muscular strength of the quadriceps muscle and the bone quality of the heel, measured with a quantitative ultrasound system (the Lunar Achilles InSight) ,25. TablAn X-ray will be made of the lumbar spine from both the anterior-posterior view and the lateral view. If patients have complaints of the thoracic spine, both X-rays will also be made of the thoracic spine. The X-rays and the radiologic report(s) will be requested at the hospital. The X-rays will be scored on the following features:1) Disc degeneration will be evaluated using the grading system proposed by Lane et al. , based o2) Spondylolysthesis will be scored if the intervertebral sliding is > 2 mm .3) Osteoporotic fractures will be evaluated using the system designed by Genant et al. Using this system, fractures are subdivided into 3 grades depending on the percentage of height reduction of the vertebrae: grade1 = mild, grade 2 = moderate and grade 3 = severe . All fra4) Degenerative scoliosis will be defined as a lateral spinal curvature with a Cobb angle of 10° or more .The baseline questionnaires will be filled in by patients before or just after the physical examination. The follow-up questionnaires will be sent  at 6 weeks and at 3, 6, 9, and 12 months after the patient completed the baseline questionnaire. The questionnaires include outcome measures and prognostic factors, and are based on the recommendations presented in the Multinational Musculoskeletal Inception Cohort Study (MMICS) Statement .Table The outcome measures included in the study will be global perceived effect, severity of back pain, recurrence of the back complaint, disability, quality of life, productivity loss during follow-up, medical consumption, and final diagnosis given by the GP.Global perceived effect (GPE) will be measured on a 7-point scale, ranging from 'completely recovered' to 'worse than ever' ,32.Severity of back pain will be measured on an 11-point numerical rating scale (NRS)  in whichDifferent measurements will be used to gain insight into the recurrence of back complaints: the duration of the complaint (in days) and the duration of the pain-free period (in days). To define recurrence of back pain the definitions proposed by Stanton et al. and De Vet et al. are used ,35: a reAll patients with a paid job will also complete the Productivity and DISease Questionnaire (PRODISQ) , which iTo determine medical consumption, we will record back pain medication and the number of consultations with different healthcare professionals.To determine the presence of serious pathologies, which can become apparent over time, GPs are asked to fill in a short questionnaire about the diagnosis of the back complaints at one-year follow-up.The following potential prognostic factors will be measured in the questionnaires: 1) demographic characteristics e.g. age and gender, 2) characteristics of the compliant e.g. duration of the complaint, the perceived cause, pain response to activity and position, 3) baseline functional disability (RDQ), 4) lifestyle e.g. smoking and alcohol use, 5) comorbidity (Self-administered Comorbidity Questionnaire), 6) psychological factors e.g. kinesiophobia, pain catastrophizing, back beliefs, expectations of recovery, emotional well-being, 7) work-related factors e.g. physical workload, job satisfaction and co-workers' support and 8) received treatment due to the back complaints e.g. medication and number of consultations. We will also measure characteristics of the national health system of the different countries joining the BACE consortium .Based on the literature, 26-45% of the older adult population with acute low back pain will develop chronic persistent back complaints ,12,40,41To identify prognostic factors by means of multivariate regression analysis, 750 older adults with a new episode of back pain need to be included. This group consists of about 225 patients (0.3 * 750) that will have chronic back complaints. A minimum of 10 patients with chronic back complaints are needed to produce stable estimates for each prognostic factor. The estimated size of 225 subjects with chronic complaints, allows for multivariate regression analysis including 22 variables. These sample size calculations concern the individual national BACE studies. Combining the cohort data will obviously increase the statistical power of the analysis.Insight into the duration, severity and clinical course of back pain in the elders will be provided using descriptive statistics. Furthermore, descriptive statistics will provide insight into the level of functional disability, quality of life, productivity loss, medical consumption and prevalence of underlying pathology and X-ray findings. To evaluate the diagnostic value of the 'red flags', the sensitivity and specificity of the red flags will be calculated.To identify prognostic factors for the transition from acute back complaints to chronic back complaints, we will first assess which factors of the baseline questionnaire and the physical examination are associated with chronic back complaints. A binary logistic regression analysis will be performed with these factors. Chronic back complaints are defined as back complaints lasting more than 3 months ,43. GlobThe BACE study will be conducted in different countries: starting in the Netherlands, Brazil and Australia. The aims of this collaboration are: to perform individual patient data meta-analyses, to validate prognostic models, to investigate the effects of cultural, economic and health care system differences on the clinical course of back pain, and to investigate cross-cultural differences in the treatment of back complaints in older people. The design will be the same across the studies, and a common set of outcome measures and possible prognostic factors will be used. The physical and X-ray examinations will be standardized. Same recruitment strategies will be implemented and the same inclusion and exclusion criteria will be used. All statistical analyses will be performed with the data of the different research groups separately and, if applicable, also together.The BACE study in the Netherlands (BACE-D [Dutch]) started recruiting patients in 2009 and plans to end recruiting in September 2011. The Brazilian study (BACE-B) has been funded and is currently in preparation and starts recruitment of patients in September 2011. The Australian study (BACE-A) is applying for research funding.The Consortium aims to assist other international research groups in the use of this proposed protocol to allow further cross-cultural comparisons and increase statistical power by enabling meta-analyses using individual patient data.A recent Australian cross-sectional study described that older people reporting pain and pain-related disability were more likely to have fallen in the past 12 months than people not reporting pain . TherefoThe additional objectives are:1) To establish the two-year incidence of falls, loss of independence, hospitalization, and institutionalization in back pain patients.2) To identify prognostic factors for falls, loss of independence, hospitalization and institutionalization in back pain patients.The BACE-D study will extend the follow-up period to five years. The additional long-term follow-up questionnaires will be sent at the 2, 3, 4 and 5-year follow-ups and will be the same as the 12-month questionnaire. After 5 years of follow-up anterior-posterior and lateral X-rays will be made of the lumbar spine. X-rays of the thoracic spine will only be made if the patient has complaints in the thoracic spine at follow-up; these will be scored in the same way as the baseline X-rays.This cohort study will provide insight into the course of back complaints in older people visiting their GP and aims to identify prognostic factors for the transition from acute back complaints to chronic back complaints in the elders. Research groups in the Netherlands, Australia and Brazil already collaborate in the BACE consortium. This collaboration will allows to investigate cross-cultural differences between older people with back complaints and to increase the statistical power by enabling meta-analyses using the individual patient data. It will also allow us to investigate the influence of the national health care systems on the course and treatment of patients with back complaints. People’s health can be influenced by several factors such as guidelines, availability of health care, form of insurance and insurance costs .We invite other research groups worldwide to join the BACE consortium, if interested.The authors declare that they have no competing interests.PAJL, SMAB-Z, WCP, MWvT, AMB, MYB and BWK developed the original concept of the study and developed the design of the national BACE-D cohort study. BWK and CGM conceived the idea of an international BACE Consortium. CGM and MLF developed the design of BACE-A and BACE-B. JS participated in the design of the BACE-D cohort study, is the coordinator of BACE-D and prepared the manuscript. All authors have read and approved the final version of the article.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2474/12/193/prepub


Inguinal hernia repair is one of the most common surgical procedures worldwide. This procedure is increasingly performed with endoscopic techniques (laparoscopy). Many surgeons prefer to cover the hernia gap with a mesh to prevent recurrence. The mesh must be fixed tightly, but without tension. During laparoscopic surgery, the mesh is generally fixed with staples or tissue glue. However, staples often cause pain at the staple sites, and they can cause scarring of the abdominal wall, which can lead to chronic pain. We designed a trial that aims to determine whether mesh fixation with glue might cause less postoperative pain than fixation with staples during a transabdominal preperitoneal patch plastic repair.The TISTA trial is a prospective, randomized, controlled, single-center trial with a two-by-two parallel design. All patients and outcome-assessors will be blinded to treatment allocations. For eligibility, patients must be male, ≥18 years old, and scheduled for laparoscopic repair of a primary inguinal hernia. One group comprises patients with a unilateral inguinal hernia that will be randomized to receive mesh fixation with either tissue glue or staples. The second group comprises patients with bilateral inguinal hernias. They will be randomized to receive mesh fixation with tissue glue either on the right or the left side and with staples on the other side. The primary endpoint will be pain under physical stress, measured at 24 h after surgery. Pain will be rated by the patient based on a numeric rating scale from 0 to 10, where 10 equals the worst pain imaginable. A total of 82 patients will be recruited . This number is estimated to provide 90% power for detecting a pain reduction of one point on a numeric rating scale, with a standard deviation of one.Patients with bilateral hernias will receive two meshes, one fixed with glue, and the other fixed with staples. This design will eliminate the inter-individual bias inherent in comparing pain measurements between two groups of patients.NCT01641718ClinicalTrials.gov: Inguinal hernias are the most common hernia; they account for 90% of all spontaneous hernias. Moreover, inguinal hernia repair is the most frequently performed procedure in general surgery. In Germany, more than 200,000 inguinal hernias are repaired annually,2. The sMany factors determine whether patients experience postoperative pain, including the type of intervention, the presence of complications, patient age, and individual tolerance. In particular, the type of mesh fixation employed for the hernioplasty has a strong influence on postoperative pain,17. In aThis study protocol describes a two-by-two trial design that will be used to compare the two fixation methods in two groups of randomized patients; one group with unilateral hernias and the other group with bilateral hernias. The latter group will allow a comparison of the two methods in a single patient. This design will eliminate the inter-individual bias that may influence the unilateral hernia group. This study focuses on early postoperative pain, particularly during the first two postoperative days. In many other studies, pain is first measured one month after surgery.The aim of this trial is to investigate early and late postoperative pain after laparoscopic hernia repair with the TAPP technique, using either fibrin glue or staples for mesh fixation.The study was planned according to the updated Consolidated Standards of Reporting Trials (CONSORT) statement. The study design is in compliance with the Declaration of Helsinki, the Guidelines of Good Clinical Practice issued by ICH, and the requirements of Swiss regulatory authorities-27.This trial is a double blind, randomized, controlled trial with a two-by-two design, conducted at a single institution. The study aims to compare pain after mesh implantation, when fixed either with staples or glue, in a superiority analysis. The CONSORT diagram of the trial is depicted in Figure Patients scheduled for elective laparoscopic primary inguinal hernia repair at the Department of Surgery, Kantonsspital St. Gallen, will be screened for enrollment in the trial. Informed consent will be obtained, at the latest, on the day before surgery, after ascertaining that the patient meets the eligibility criteria.Patients that match the following criteria are eligible for inclusion in the clinical trial:• age, 18 years or older• male gender• primary hernia repair (no re-operations for a recurrent hernia)• no chronic pain• no acute pain that requires analgesics, other than paracetamol or more than a single dose of non-steroidal anti-inflammatory drug treatment within 48 h before surgery• no current treatment with psychopharmaceutical drugs• good compliance can be expected• no mental incapacity• no known incompatibility  with Tisseel compounds• informed consentUnder the following circumstances, patients will be excluded from the trial:• hernia is inoperable with TAPP, due to the size, previous abdominal surgery (assuming a damaged peritoneum), or expected adhesions• repair requires an intra-operative change to another hernia repair technique (e.g. open access methods)• the patient wishes to stop further trial participationWhen the patient refuses further participation after receiving surgery, the patient will receive a safety check-up during a one-month follow-up. Otherwise, the patient will not receive the study treatment and will not require a study-related safety follow-up.The primary objective of this trial is to show that after TAPP repair for unilateral and bilateral inguinal hernias the acute postoperative pain caused by mesh fixation with tissue glue is less than with staple fixation.The primary efficacy endpoint of the TISTA trial is pain under physical stress at 24 h after surgery. Pain will be rated by the patient using a numeric rating scale (NRS). The NRS ranges from 0 to 10 in steps of one, with 0 representing no pain at all and 10 the worst imaginable pain. The NRS is comparable to the visual analogue scale (VAS) where the degree of pain is marked on a 10 cm long line. In practical terms, average NRS and VAS scores (in cm) can be considered equivalent. The patient is first asked to rate the pain at rest and then to rate it after physical stress. Physical stress is induced by a 90° bending of the hip joint on the operated side(s). The secondary endpoints of the trial and their definitions are summarized in Table Patient intra- and peri-operative care will be standardized and maintained identical for each patient, except for the mesh fixation technique. The patients will receive combined neuraxial and general anesthesia.The abdomen will be accessed and the pneumoperitoneum will be achieved with standard laparoscopic techniques. The preperitoneal space will be exposed transabdominally with a sharp incision, followed by bluntly stripping the peritoneum that overlies the inguinal anatomy. An Ultrapro® mesh  will be deployed and fixed in place with either staples or glue, and then the peritoneum will be returned to its anatomical position.At an umbilical site, a Veress needle is inserted to induce a pneumoperitoneum, and then the needle is replaced with a 10 to 12 mm optical trocar. Next, two 5 mm trocars are positioned bilaterally on the umbilical line in the iliac fossa. An incision is made in the peritoneal wall, starting at the level of the superior margin of the internal inguinal ring and at the level of the epigastric vessels. The incision is extended medially, up to the residue of the umbilical artery, and then laterally, 3 to 4 cm past the inguinal ring; the total incision length is 7 to 8 cm. In the presence of a direct hernia, the hernial sac is directly isolated and reduced. In the case of an indirect or femoral hernia, the preperitoneal parapubic adipose tissue is carefully dissected medially to expose the horizontal pubic ramus and Cooper’s ligament. Accurate dissection of the preperitoneal retrovesical tissue facilitates positioning the mesh. The internal inguinal ring is explored, and the hernial sac is isolated and reduced; this maneuver is performed to reveal the presence of perihernial lipomas, which can then be removed. Once the spermatic cord is freed from the peritoneal wall, a macroporous, partially absorbable Ultrapro mesh (Ethicon) is positioned. This type of mesh allows the surgeon to view the underlying structures, which facilitates positioning the mesh. The mesh is cut to 10 × 13 cm and placed in the preperitoneal space such that it is in medial contact with the paravesical area, it covers Cooper’s ligament, it rests on the inguinal region, and it extends laterally over the epigastric vessels.For this procedure, the mesh is fixed with an Endopath Multifeed Stapler with a 10 mm shaft and helical titanium staples . The technique that we adopted involves positioning two metal clips at the level of Cooper’s ligament and the pubic tubercle. Additionally 4 staples are placed laterally at the level of the deep inguinal ring medially and laterally to the inferior epigastric vessels with absorbable staples . The peritoneal flap is then closed with four additional absorbable staples.For this procedure, the mesh is anchored with 2 mL of fibrin glue . Tisseel is applied to both anterior and posterior sides of the mesh with a dedicated laparoscopic tool  inserted into a 5 mm trocar. To obtain optimal bonding between the Tisseel on the mesh and the peritoneal wall, slight pressure is applied to the mesh with the Duplotip. The Tisseel is applied to the entire perimeter of the mesh, and in particular, at the level of the superior margin, the “triangle of disaster,” in proximity of the prevesical fat, to assure good adhesion. The peritoneal flap is then closed with small, continuous, absorbable 2/0 sutures.To reduce bias, the postoperative regime is standardized for the study. All patients will receive the same intra- and perioperative care, except for the mesh fixation technique. The postoperative care will also be uniformly administered, and changes will only be made when the patient’s comfort or safety is compromised. All patients will be mobilized as soon as possible during the postoperative period. All patients will receive paracetamol (three 1 g doses per 24 h), administered either intravenously (early postoperative course) or orally (late postoperative course).Additional analgesia will be provided as required according to the following scheme:• First line reserve: metamizole, maximum 4 g/24 h• Second line reserve (if necessary): morphine, 1-2 mg, delivered intravenouslyThe use of additional analgesics will be documented.Patients will be randomized according to the following scheme:Primary arm 1: Patients with a unilateral inguinal herniasecondary arm 1: mesh fixation with tissue gluesecondary arm 2: mesh fixation with staplesPrimary arm 2: Patients with bilateral inguinal herniassecondary arm 1: right side, tissue glue; left side, staplessecondary arm 2: right side, staples; left side, tissue glueThe patients will be randomly assigned to the treatment, and the patients will be blinded to the assigned treatment. In primary arm 2 , the bias of individual pain perception can be eliminated, because a single individual decides (blindly) which side is more painful.The treatment assignment will be based on a block randomized list (one for each primary arm) with variable block sizes (between 2 and 6 patients per block). After each patient signed the informed consent, his name will be entered into the study database. At the beginning of surgery, the patients scheduled for unilateral repair will be examined laparoscopically to determine whether the other side also requires repair. The final decision for uni- or bilateral repair can only be made after this intra-operative examination. Thus, randomization will occur during surgery by contacting the study nurse to receive the treatment allocation. In the absence of the study nurse, the data manager can provide the allocation information. The data manager generates the randomization list and maintains a secured copy of the assignment list. The pain scores are obtained by nurses or physicians that are not aware of the treatment assignment (observer blinding).In the case of unforeseen postoperative complications, the treating physician (surgeon) will know the treatment assignment and can be reached by phone. Furthermore, the data manager can unblind the assignment when necessary. Any unblinding will be recorded in the study documentation.The sample size was calculated under the hypothesis that either glue fixation or staple fixation is superior for the primary endpoint (= pain after 24 h). Lovisetto reported a mean VAS pain score of 1.9 for glue fixation and 2.6 for staple fixation one month after TAPP repair. The obsBased on these assumptions, we calculated that 23 patients per arm would be required for unilateral hernias (t-test for two independent samples with common variance). Assuming a drop-out rate of 20%, the total number of patients needed per arm is 29, resulting in a total of 58 patients with unilateral hernias. For the second arm with bilateral hernias we calculated that 19 patients would be required (t-test for paired samples), assuming an intra-individual correlation of 0.2 . With a drop-out rate of 20%, a total of 24 patients with bilateral hernias would be required, resulting in a total of 82 patients for the entire study.With an annual case load of approximately 100 in the previous years, we estimate that patient recruitment should be achieved within one or two years.The statistical analysis will be performed with SPSS Statistics for Windows . A two-sided p-value <0.05 will be considered statistically significant. Descriptive statistics will be used to analyze the baseline characteristics. For the superiority analysis of pain intensity at 24 h after surgery, the Mann−Whitney U and Wilcoxon tests will be applied, as appropriate. To adjust for multiple testing, the Hochberg procedure will be applied.Pain measurements performed at 4, 8, 12, 24, 36, 48 h after surgery by patients with unilateral and bilateral hernias will be analyzed in one mixed model to assess the mean ranks of the NRS scores with adjustments for time, treatment, and unilateral versus bilateral hernias. To compare other continuous secondary endpoints , the Mann−Whitney U and Wilcoxon tests will be applied, as appropriate. Chi-square statistics will be used to compare categorical secondary endpoints . Auxiliary, non-confirmatory analyses will be performed to assess the influences of baseline patient characteristics and treatment characteristics on the primary and secondary outcomes.Intermittent missing values will be replaced by linear interpolation . No interim analysis is planned for this study. Data from patients withdrawn from the study will be disregarded, unless exclusion is based on a postoperative patient request, and the patient agrees to the use of existing documented data.The confirmatory analysis will be performed based on an intention-to-treat (ITT) design, and it will adhere to ITT principles. When a protocol violation occurs, a per protocol analysis (PP) will be performed for comparison.This study will be conducted in agreement with either the Declaration of Helsinki  or the local laws and regulations of the country, whichever provides the greatest protection for the patient. This protocol, the patient information sheet, and the patient consent form have been reviewed and approved by the local Ethics Committee (EKSG 12/080) and by Swissmedic (TpP_I_2012_003) prior to enrolling any patients in this trial.All patients will be informed of the aims of the study, the possible adverse events, the procedures and possible hazards to which they will be exposed, and the mechanism of treatment allocation. They will be informed about the strict confidentiality of their patient data and told that their medical records may be reviewed for trial purposes by authorized individuals other than their treating physician. The signed consent document will be maintained by the investigator. A copy of the signed consent document will be given to the patient or the patient’s legally authorized representative.It will be emphasized that participation is voluntary, that the patient is allowed to refuse further participation in the study at any time, and that any refusal will not influence the patient’s subsequent care. Documented informed consent must be obtained for all patients included in the study before they are registered or randomized in the study. Registration and randomization will be conducted in accordance with the national and local regulatory requirements.Maintaining patient confidentiality is the responsibility of the investigator. During the trial, the patients will be identified solely based on an individual identification code. The trial findings will be stored in accordance with local data protection law/ICH GCP Guidelines, and they will be handled in the strictest confidence. For the protection of these data, organizational procedures have been implemented to prevent distribution of the data to unauthorized individuals.The investigator will maintain a personal subject identification list (screening numbers with the corresponding subject names) to ensure the records can be identified when necessary.This study was designed as a randomized trial with a two-by-two, parallel design. We aimed to compare patients with unilateral hernias that received mesh implants, fixed with either tissue glue or staples and to evaluate patients with bilateral hernias that received mesh implants fixed with tissue glue on one side and staples on the other side. In the latter group, the same patient will rate the pain associated with both methods; these ratings will not be influenced by inter-individual biases present in the unilateral hernia arm. To further reduce biases, both patients and observers  will be blinded to the assigned treatment.We expect that mesh implants fixed with tissue glue will be associated with less postoperative pain, shorter hospital stay, and a shorter sick leave after the operation compared to implants fixed with staples. In addition to enhancing patient comfort, the tissue glue fixation will also have an economic impact, by reducing health care costs. Because we can evaluate both inter-individual and intra-individual biases in pain perception, this study will provide important insights for future studies that aim to investigate pain. This study will therefore provide novel information that is currently lacking in the literature.st, 2013, and recruitment is ongoing.The trial began on February 1TIsseel versus STAples); VAS: Visual analogue scale (for pain measurement).CONSORT: Consolidated Standards of Reporting Trials; GCP: Good clinical practice; ICH: International Conference on Harmonisation; ITT: Intention to treat; NRS: Numeric rating scale (for pain measurement); PP: Per protocol; TAPP: Transabdominal preperitoneal patch plastic; TEP: Total extraperitoneal (repair); TISTA: This study’s acronym (The authors declare that they have no competing interests.SAM and IT developed the original study design. SAM, UB, and IT developed the research protocol. RW and IT performed the sample size calculations. SAM, BMS, CL, and IT are responsible for the clinical input. SAM, RW, IT, and UB drafted the manuscript. All authors have approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2482/14/18/prepub