Rehabilitation following surgery: Clinical and psychological predictors of activity limitations Short running title: Activity limitations after surgery. Rachael Powell1, Marie Johnston2, W Cairns Smith3, Peter M King4, W Alastair Chambers5, Lorna McKee6, Julie Bruce7. 1 School of Psychological Sciences and Manchester Centre for Health Psychology, University of Manchester, Manchester, UK. 2 Health Psychology, University of Aberdeen, Aberdeen, UK. 3 School of Medicine and Dentistry, University of Aberdeen, Aberdeen, UK. 4 Department of Surgery, Aberdeen Royal Infirmary, Aberdeen, UK. 5 Department of Anaesthesia, Aberdeen Royal Infirmary, Aberdeen, UK. 6 Health Services Research Unit, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK. 7 Warwick Clinical Trials Unit, Division of Health Sciences, Warwick Medical School, The University of Warwick, Coventry, UK. Corresponding author: Dr Rachael Powell School of Psychological Sciences and Manchester Centre for Health Psychology, University of Manchester, Coupland 1 Building, Oxford Road, Manchester, M13 9PL UK Telephone: +44 121 204 4188 Email: rachael.powell@manchester.ac.uk 1 Abstract Purpose/Objective: Activity limitations following surgery are common and patients may have an extended period of pain and rehabilitation. Inguinal hernia surgery is a common elective procedure. This study incorporated fear avoidance models in investigating cognitive and emotional variables as potential risk factors for activity limitations at 4 months after inguinal hernia surgery. Research Design/Method: This was a prospective cohort study, predicting activity limitations 4 months postoperatively (T3) from measures taken before surgery (T1) and 1 week after surgery (T2). The sample size at T1 was 135; response rates were 89% and 84% at T2 and T3 respectively. Questionnaires included measures of catastrophizing, fear of movement, depression, anxiety, optimism, perceived control over pain, pain and activity limitations. Biomedical and surgical variables were recorded. Predictors of T3 activity limitations from T1 and T2 were examined in hierarchical multiple regression equations. Results: Over half of participants (57.7%) reported activity limitations due to their hernia at 4 months after surgery. Higher levels of activity limitation were significantly predicted by older age, higher pre-operative activity limitations, higher pre-operative anxiety, and more severe post-operative pain and depression scores. Conclusions/Implications: Interventions to reduce pre-operative anxiety and post-operative depression may lead to reduced 4-month activity limitations. However, the additional variance explained by psychological variables was low (ΔR2 = 0.05). Our models, which included biomedical and surgical variables, accounted for less than 50% of the variance in activity limitations overall therefore further investigation of psychological variables, particularly cognitions related specifically to activity behavior, would be merited. 2 Keywords Hernia surgery; inguinal hernia; activity limitations; functional limitations; depression; fear avoidance. Impact It has previously been demonstrated that some people experience delayed recovery and persisting activity limitations after hernia repair surgery, but little research has been conducted which incorporates psychological models in predicting such limitations. This study has identified pre-operative anxiety and post-operative depression as independent predictors of activity limitations four months after hernia surgery after accounting for pain, previous activity limitations and biological and surgical variables. Rehabilitation interventions targeting pre-operative anxiety and depressed mood in the acute postoperative period might assist in promoting postoperative rehabilitation and reduce activity limitations after hernia surgery. Nevertheless, the models utilized in the present study left much variance in activity limitations to be accounted for. A worthy direction for further research would be to investigate beliefs about activity. 3 Introduction Chronic post-surgical pain after hernia surgery has been associated with functional limitations and in this paper we investigate predictors of persistent limitations in order to inform rehabilitation programs. In 2009-2010, over 71,000 surgical repairs were completed for inguinal hernia in England alone; 93% of these were in men (The NHS Information Centre, 2010). Rutkow and Robbins (1993) reported that approximately 680,000 hernia repair operations were performed annually in the USA. However, a significant proportion of patients experience activity limitations and chronic post-surgical pain following hernia surgery, defined as pain persisting for at least three months (International Association for the Study of Pain Subcommittee on Taxonomy, 1986). In a review of 40 studies, Poobalan et al. (2003) found that prevalence of chronic pain after inguinal hernia surgery ranged from 0 to 54% depending upon the method and timing of assessment. Courtney, Duffy, Serpell and O’Dwyer (2002) followed up people with severe pain three months after hernia surgery and found that 71% still experienced pain two and a half years later. This persistent pain was reported to be disabling and to interfere with activities including walking and sleeping at all levels of severity, although the impact was greatest in those reporting severe pain. Bay-Nielsen et al. (2001) found 29% of patients reported pain one year after inguinal hernia surgery and for 11% this pain affected their work or leisure activity. As will be discussed below, psychological factors have been demonstrated to predict disablement in various health contexts. Psychological factors likely to be important include fear, anxiety and catastrophizing (as encompassed within fear-avoidance models), depression, control cognitions and optimism. Fear avoidance models could have important implications for individuals in the recovery and rehabilitation phase after surgery. These models suggest that the association between pain 4 and activity limitation is mediated by psychological variables (Kori, Miller, & Todd, 1990; Lethem, Slade, Troup, & Bentley, 1983; Philips, 1987). It is proposed that people who avoid activity that causes pain do not reduce their fear of pain through exposure to the pain stimulus. Reduced activity may then lead to physical consequences such as loss of muscle strength (Bortz, 1984). Thus, pain, activity and fear avoidance are linked in a negative spiral. People who catastrophize about pain, defined as those who have ‘an exaggerated negative orientation toward noxious stimuli’ (Sullivan, Bishop, & Pivik, 1995) are proposed to be more likely to experience pain-related fear and anxiety, to avoid activities that are associated with pain and thus to experience higher levels of disability (Leeuw et al., 2007; Vlaeyen, Kole-Snijders, Boeren, & van Eek, 1995). Archer et al. (2011) found that post-operative, but not pre-operative, fear of movement predicted post-operative disability in people undergoing spinal surgery. Negative emotions more generally have been demonstrated to predict slower recovery of activity. Negative affect was found to predict activity limitations in people recovering from stroke (Powell, Johnston, & Johnston, 2008) and may also be relevant when recovering from surgery. Higher levels of depression predicted worse activity limitations after coronary artery bypass graft surgery (Kendel et al., 2010). Depression measured before surgery predicted activity limitations two months after surgery, and depression two months after surgery predicted activity limitations at one year after surgery. Seebach et al. (2012) found that negative affect and depression measured six weeks after discharge following spinal surgery predicted disability at three months post-discharge. From a fear-avoidance perspective, it is likely that someone who perceives pain as controllable or manageable would be less anxious and fearful about activities that might lead to pain. Pain ‘coping efficacy’ has been associated with increased physical functioning at six 5 months after knee replacement surgery (Engel, Hamilton, Potter, & Zautra, 2004). It is, therefore, important to consider the role of perceptions of control over pain when investigating return to physical activity and function after surgery. Moving from pain-specific cognitions to a more general perspective, Scheier and Carver (1985) argue that generalized expectancies (optimism) are important because situations that people encounter may require complex solutions with multiple components rather than a specific behavior. Thus, generalized expectancies may be important in predicting response to a novel situation, where a person has no experience on which to base specific expectancies. For many, the process of surgery, recovery and rehabilitation is a novel experience, and there are a range of activity behaviors that an individual must regain. Optimism has predicted return to normal activity after coronary artery bypass surgery (Scheier et al., 1989) and recovery after various elective operations (Peters et al., 2007). There is emerging evidence that psychological factors contribute to activity recovery after elective surgery. This prospective study aimed to investigate predictors of activity recovery at four months after inguinal hernia repair surgery in order to determine whether a model incorporating psychological constructs alongside biological factors might improve our understanding of activity limitation during the rehabilitation period and to identify opportunities for intervention. In particular, we wanted to examine the impact of pre- and post-operative cognitive and emotional factors on activity recovery, independently of the impact of pain. We hypothesized that activity limitations at four months after surgery would be predicted by higher anxiety, depression, catastrophizing and fear of movement and lower optimism, perceptions of control over pain, and coping with pain by increasing activity. 6 Methods Design The study design was a prospective cohort study of people undergoing inguinal hernia surgery. Clinical and questionnaire data were collected at three time points: before surgery (Time 1,T1), one week after surgery (Time 2, T2) and four months after surgery (Time 3, T3). Questionnaires included measures of pain and emotion and cognitive variables which were used to predict T3 activity limitations. Participants People undergoing inguinal hernia surgery at two hospitals in North East Scotland between December 2006 and March 2008 were invited to take part. Recruitment packs were sent to 355 patients by hospital administrative staff approximately two weeks before surgery. This study was approved by Grampian Research Ethics Committee and NHS Grampian Research and Development. Measures Activity Limitations SF-36 Physical Functioning Subscale (SF-36 PF); Version 2, Acute Form (Ware, Kosinski, & Dewey, 2000) (All time points) The SF-36 is ‘the most widely-used health status questionnaire in the world’ (Ware et al., 2000, p6) and has received substantial psychometric evaluation since it was published in 1988 (Ware, 1988). The physical functioning subscale asks participants to indicate the extent to which their health limits them on ten activities e.g. ‘Vigorous activities such as running, lifting heavy objects, participating in strenuous sports’, ‘lifting or carrying groceries’ and ‘bathing or dressing yourself’. Participants indicate whether they are limited a lot, limited a 7 little or not limited at all for each item. The standard scoring procedures were followed, yielding scores on a scale from 0 to 100, where higher scores indicate fewer limitations. Pollard, Johnston and Dieppe (2006) classified SF-36 items according to the ICF definitions of impairment, activity limitations and participation (World Health Organisation, 2001). In the SF-36 PF subscale, all items were found to assess activity limitations with three items also assessing participation (details in personal communication from Pollard, 2010). The SF36 PF subscale has been used to assess postoperative activity recovery (e.g. Engel et al., 2004; Kendel et al., 2010). In the present data set, Cronbach’s alpha for SF-36 PF was 0.87, 0.89 and 0.88 for T1, T2 and T3 respectively. SF-36 PF was the primary outcome measure in all multiple regression analyses. Hernia Physical Functioning (Hernia PF) (All time points) The SF-36 PF detects all-cause activity limitation. In order to describe the activity limitation experienced by participants which they attributed specifically to their hernia, the Hernia PF measure was devised: a 10-item scale based on the SF-36 PF. Participants were asked to what extent they were limited by their hernia for the same activities as described by the SF36 PF. The response scale and scoring method described for the SF-36 PF were followed. Cronbach’s alpha = 0.87, 0.88, 0.82 for T1, T2 and T3 respectively. This measure was used descriptively and as an outcome measure for secondary, exploratory analyses. Emotional and cognitive variable measures Anxiety and Depression: Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983) (T1 and T2) The HADS was designed to assess anxiety and depression without being confounded by somatic symptoms indicating physical disorders. The scale contains 14 items, seven to assess depression and seven for anxiety. Good psychometric properties have been reported 8 (Johnston, Pollard, & Hennessey, 2000; Moorey et al., 1991; Zigmond & Snaith, 1983). Higher scores indicate higher anxiety or depression. In the present sample, the scales had acceptable internal consistency: Cronbach’s alphas were 0.87, 0.82 for Anxiety and 0.80, 0.79 for Depression at T1 and T2 respectively. Fear of Movement: Tampa Scale for Kinesiophobia (TSK-11) (Woby, Roach, Urmston, & Watson, 2005) (T1 and T2) The TSK was developed to assess pain-related fear, and the impact of that fear on movement. Woby et al. (2005) reduced the original TSK (Miller, Kori, & Todd, 1991) to an 11-item scale and demonstrated that its psychometric properties were similar to the original 17-item scale. As some people with a hernia experience little or no pain the scale was split into the eight items that do not assume the person to have pain (e.g. ‘Pain always means I have injured my body’) and the remaining three items that assume the individual is experiencing pain (e.g. ‘I wouldn’t have this much pain if there weren’t something potentially dangerous going on in my body’). All participants were asked to complete the eight items that do not assume pain; participants who were painfree were directed to skip the three items that assume pain. The reliabilities of the full, 11-item measure and the shortened, 8-item measure were compared: at T1 Cronbach’s alpha = 0.77 and 0.79; at T2 Cronbach’s alpha = 0.76 and 0.82 respectively. The correlation between the 11- and 8-item scales was extremely high at both time points (r=0.97 (T1), r=0.97 (T2), p<0.001 each time). The 8-item measure was used in all analyses.1 Higher scores indicate greater fear of movement. Catastrophizing: from Pain Coping Strategies Questionnaire (CSQ) (Rosenstiel & Keefe, 1983) (T1 and T2) 1 A sensitivity analysis was conducted, entering the full TSK-11 scores into the Stage 3 multiple regression with primary outcome SF-36 PF). Findings were similar with both measures. 9 The CSQ includes a 6-item subscale assessing Catastrophizing when feeling pain, e.g. ‘It is terrible and I feel it is never going to get any better’. Items were scored on a scale from 0 (never do that) to 6 (always do that). In the present data set, Catastrophizing yielded Cronbach’s alphas of 0.73 and 0.91. However, the data were highly skewed (T1 skew = 2.15, kurtosis = 5.2; T2 skew = 3.8; kurtosis = 17.9), with skew persisting after transformation. Inspection of the data showed that high numbers of participants scored 0 (62 of 117 preoperatively; 55 of 113 post-operatively). A bivariate Catastrophizing score was therefore calculated: participants who scored 0 were allocated 0 (non-catastrophizers), all other scores were allocated 1 (catastrophizers). The split was placed between scores of 0 and 1 on logical grounds as this separated those who responded ‘never do that’ to all items of catastrophizing from those who reported any degree of catastrophizing. Increasing Activity, Control, Ability to Decrease Pain (CSQ) (Rosenstiel & Keefe, 1983) (T1 and T2) In addition to the Catastrophizing sub-scale, the other sub-scales of the ‘Helplessness’ dimension of the CSQ questionnaire were used: Increasing Activity, Control of Pain and Ability to Decrease Pain. The Increasing Activity subscale consisted of 6 items assessing various activities as responses to feeling pain, e.g. ‘I do anything to get my mind off the pain’. Items were scored on a scale from 0 (never do that) to 6 (always do that). Higher scores indicate greater use of increasing activity as a pain coping strategy. In the present data set, Increasing Activity produced Cronbach’s alphas of 0.80 and 0.73 at T1 and T2 respectively. Control of Pain consists of a single item: ‘On an average day, how much control do you feel you have over your pain?’ with responses on a scale from 0 (no control) to 6 (complete control). Ability to Decrease Pain is also measured with a single item: ‘On an average day, how much are you able to decrease your pain?’ with responses from 0 (can’t decrease it at all) to 6 (can decrease it completely). 10 Optimism: Life Orientation Test (LOT, Scheier & Carver, 1985) (T1 and T2) Scheier and Carver (1985) designed the LOT to measure dispositional optimism. The fulllength scales consists of 8 items but items 4 and 8 may be used on their own (Johnston, Wright, & Weinman, 1995); these two items were used in the present study: 1:‘I always look on the bright side’ and 2: ‘I hardly ever expect things to go my way’. Responses are given on 5-point scales from ‘I agree a lot’ to ‘I disagree a lot’. Item 2 was reverse-scored and the two items were summed such that high scores indicate greater optimism. Correlations between the two items were r=0.30 and r=0.35 (p<0.001) for both correlations), T1 and T2 respectively. Pain McGill Pain Questionnaire (MPQ, Melzack, 1975) (T1 & T2) Psychometric properties of the MPQ were demonstrated by Melzack (1975). The present study used the measure Number of Words Counted (NWC) in analysis. NWC is derived by asking participants to select words that describe their pain from a list of 78 descriptors. Descriptors are divided into 20 subclasses; participants can only select a single word from any category therefore pain scores range from 0 to 20, with higher scores indicating greater pain. Use of painkiller medication (T2). Participants were asked whether they were taking pain-killer medication (Yes/No). Surgical variables 11 Medical records were checked to confirm the type of surgery (open or laparoscopic, primary or recurrent), surgery duration and anesthetic used during the procedure (general, local or both). The type of mesh was also recorded and categorized as ‘lightweight’ or ‘standard weight’. At T3, participants reported retrospectively whether or not they had experienced any complications after surgery. The following time period data were recorded: a) Completion of T1 questionnaire to operation; b) Operation to T2 questionnaire; c) Operation to T3 questionnaire; d) Nights in hospital post-operatively. Individual biological baseline measures Participants reported their age, height and weight at T1. Height and weight were used to calculate Body Mass Index (BMI). Procedure The recruitment packs sent to participants two weeks pre-operatively included an information sheet, consent form and the pre-operative, T1 questionnaire. Participants also received a prepaid envelope with which to return the completed consent form and questionnaire to the research team. On sending out packs, administrative staff recorded the non-identifiable details of location of surgery (right, left, bi-lateral), gender, year of birth and age. A researcher posted follow-up questionnaires at one week (T2) and four months (T3) after the surgery date. Reminder questionnaires were posted two weeks after the first mailing for T2 and T3 questionnaires. Statistical Analysis In the event of missing data, following the instructions of the SF-36 manual (Ware et al., 2000), if participants answered at least 50% of the items in a scale, the average score across completed items in that scale for that respondent were calculated. If less than 50% of the 12 items were answered, the score for the scale was recorded as ‘missing’; otherwise, the mean of the remaining items was substituted for each missing item. This rule was followed across all measures except for the HADS where the scale’s publishers recommend substituting the mean of the remaining items if no more than 20% of data are missing (GL Assessment, 20072010). Final regression models using available data were compared with models using only those participants with complete data (with item substitution where appropriate). Data were checked statistically (Z>3.29) and visually for univariate outliers and skew as recommended by Tabachnick and Fidell (2007); Mahalanobis distances were used to check for multivariate outliers (Tabachnick & Fidell, 2007). Where appropriate, scales were subjected to log transformation. Multicollinearity of independent variables was assessed by examining the correlations between variables. This was a particularly pertinent issue as some independent variables were likely to be related and, following Tabachnick and Fidell’s (2007) recommendations, if two variables had a correlation greater than 0.70 we would not include both items. The variable with the lowest tolerance in regression would be removed and the regression model repeated. Bivariate analyses were non-parametric because skew persisted for some measures (NWC and T3 Activity Limitations). Mann-Whitney U was used to compare activity limitations at T1 and at T3. Regression analyses were conducted to identify a) T1 predictors of T3 activity limitations (primary outcome measure: SF-36 PF; secondary outcome measure: Hernia PF) and b) T2 predictors of T3 activity limitations (primary outcome measure: SF-36 PF, secondary outcome measure: Hernia PF.). For both a) and b), analyses were conducted in three stages: Stage 1: Spearman’s rho, Mann-Whitney U or χ2 were performed to identify associations between risk factors (at either T1 or T2) and outcome (T3 activity limitations). Predictors associated with outcomes at p<0.2 were carried forward to Stage 2 (Bendel & Afifi, 1977). Stage 2: Variables were grouped: 13 Group 1: Surgical variables: surgery type (open/laparoscopic); recurrent/primary hernia; mesh type (standard/lightweight); uni/bilateral hernia; anesthetic (local/no local); surgery duration; presence of complications; timings (from T1 to operation, operation to T3 as relevant). Group 2: Individual biological and behavioral variables: age; BMI; Pain (T1 or T2); Activity limitations (T1 or T2 using either SF-36 or Hernia PF to match outcome measure); painkiller use (T2). Group 3: Emotional and Cognitive Variables: Anxiety, Depression, CSQ Catastrophizing, CSQ Increased Behavioral Activities, CSQ Control, CSQ Ability to Decrease Pain, Optimism (each at T1 or T2 as appropriate). Multiple regressions were carried out for each group. Variables significantly predicting the outcome at p<0.2 were carried forward to Stage 3. Stage 3: Only independent variables that predicted risk factors at p<0.2 in Stage 2 were entered into hierarchical multiple regression equations. Pain at T1/T2 was always entered into the Stage 3 regression because it is an important potential confounding variable (Hosmer & Lemeshow, 2000). Surgical variables (Group 1) were entered first, then biological and behavioral measures (Group 2). Emotional and cognitive variables (Group 3) were entered in steps three and four respectively. At this final stage, the significance level p<0.05 was used. Results Response Rates The pre-operative questionnaire was completed by 140 respondents (39.4%). There were no significant differences between respondents and non-respondents for hospital location, location of surgery (right/left/bilateral) or gender. A trend was observed for age: nonrespondents were slightly younger (mean age: 52.0 years compared with 62.1 years for respondents, t(353)=1.89, p=0.06). Five of these pre-operative questionnaires were 14 completed after surgery; these responses were excluded leaving a total of 135 eligible participants. Seven participants were unavailable for follow-up: two did not return their contact details on the consent forms and five participants’ operations were cancelled or postponed beyond the study timeframe. Questionnaires were returned by 120 participants at T2 and 114 at T3 (88.9% and 84.4% of the total sample of 135 respectively). Descriptive Statistics The majority of participants (126) were male; six were female; three did not respond to this item. The mean age of participants was 61.5 years (SD=12.0) and mean BMI was 25.7 (SD=3.26). An open repair was conducted for 84.6% participants; 15.4% had laparoscopic surgery. Most operations (91.0%) were primary repairs using standard mesh (78.0%) and were unilateral (92.6%) Most procedures were conducted using both general and local anesthesia (77.7%); the use of general anesthesia only was reported for 8.5% and local only for 13.8% of procedures. Most participants (84.1%) did not report complications resulting from surgery. The median time from T1 questionnaire completion to the operation was 13 days (IQR: 6, 23); from operation date to T2 questionnaire completion was 9 days (IQR: 8, 11); from operation date to T3 questionnaire completion was 127 days (18.1 weeks; IQR: 125, 132 days). The median number of nights spent in hospital post-operatively was 0 (IQR: 0,1). Across all measures in the analysis, 42 data points were imputed at T1, 26 at T2 and 15 at T3. As not all missing data could be imputed, the sample sizes used in the final regressions were 101 and 92 (for T1 data predicting T3 activity limitations and T2 predicting T3 activity limitations respectively2. Scales log-transformed were: Pain, Anxiety, Depression (all time 2 Complete data were available for 67 participants and sensitivity analyses were conducted of the final regressions using the data from these participants only. In the T2 regression, there were changes in variables reaching significance (Pain and Depression reached significance with available data (p=.046, p=.050) but not 15 points) and SF-36 PF (T1 and T3; transformation worsened this distributions at T2). The time periods T1 to operation and operation to T3 and post-operative hospital stay were also transformed. The direction of effect of scales was maintained after transformation. Following transformation, the SF-36 PF still displayed signs of skew. Therefore, all exploratory analyses were carried out using non-parametric analyses (Spearman’s rho and Mann-Whitney U). On conducting multiple regression equations, the distributions of residuals were inspected to assess any impact of skewed measures on these equations, and to check the assumptions of linearity and homoscedasticity. Table 1 about here Table 1 displays descriptive statistics for questionnaire measures (non-transformed). Participants reported being significantly less limited in their activity four months postoperatively than preoperatively (Z=6.15, p<0.01, SF-36 PF; Z=7.62, p<0.01, Hernia PF). Activity limitations Pre-operatively, 109 of 129 participants who completed these items (84.5%) reported some degree of activity limitation due to their hernia (scores <100 on Hernia PF). At one week after surgery, 108 of 110 (98.2%) and, at four months, 64 of 111 participants (57.7%) reported some degree of limitation due to their hernia. On the SF-36 PF measure, 114 of 131 (87.0%) participants reported some degree of limitation at T1, 114 of 118 (96.6%) at T2, and 79 of 112 at T3 (49.8%). Predicting Activity Limitations with complete data, while CSQ Decrease Pain was significant with complete data (p = .025) but not available data. However, inspection of beta estimates, 95% CIs and visual inspection of scatter plots of estimates using complete and available data did not identify major deviations from a linear relationship using the two methods. Findings using the larger, ‘available’ dataset are therefore reported. 16 Predicting SF-36 Physical Functioning T3 from T1 measures. In bivariate equations, variables found to predict SF-36 PF were: Surgical variables: mesh type and unilateral/bilateral surgery. Individual biological and behavioral variables: age, BMI, Pain, SF-36 PF. Emotional and cognitive variables: Anxiety, Depression, Fear of Movement, CSQ Control and Optimism (see Tables 2 & 3). The variables from the Stage 2 group regressions that maintained significance at p<0.2 and were entered into the Stage 3 hierarchical multiple regression equations were mesh type, unilateral/bilateral surgery, age, BMI, SF-36 PF, Anxiety and Fear of Movement. Pain did not reach this level of significance β=0.06, p=0.46), but as per the analysis plan was forced into the final multiple regression. . Tables 2 & 3 about here In the final, stage 3 regression, younger age, higher baseline physical functioning and lower anxiety predicted higher activity levels at four months after surgery (T3) (Table 4; β=-0.21, p=0.02; β=0.50, p<0.01; β=-0.24, p=0.01). Table 4 about here Predicting SF-36 PF T3 from T2 measures. The bivariate T2 predictors of SF-36 PF at T3 carried forward to the group multiple regression equations were as follows (see Tables 2 & 3). Surgical predictors: mesh type and unilateral/bilateral surgery. Individual biological and behavioral variables: age, BMI, T2 Pain, T2 SF-36 PF and T2 painkiller use. Cognitive and emotional variables: Anxiety, Depression, Fear of Movement, CSQ Control T2, CSQ Decrease Pain T2 and Optimism T2. From Stage 2 group multiple regressions, the variables to be continued to the final hierarchical multiple regression equation were: mesh type, unilateral/bilateral surgery, age, 17 BMI, SF-36 PF T2, Pain T2 and Painkiller use. When examining the cognitive and emotional variables for multicollinearity, CSQ Control and CSQ Decrease Pain were found to correlate at r>0.7 (r=0.74). CSQ Control had the lower tolerance level and was therefore removed from the group regression. The cognitive and emotional variables that met the criteria to be taken forward from the Stage 2 group multiple regression equation were Depression and CSQ Decrease Pain. All other variables failed to meet the criterion for inclusion at Stage 3. The final hierarchical multiple regression equation showed that older participants were less active than younger participants, and those with higher levels of post-operative pain were less active at four months (β=-0.51, p<0.01; β=-0.19, p=0.046 respectively) (Table 5). CSQ Decrease Pain did not reach significance (β=0.14, p=0.12) but higher levels of depression at T2 marginally significantly predicted being more limited in activity at 4 months after hernia repair surgery (β=-0.20, p=0.050). Table 5 about here Predicting Hernia PF T3 from T1 and T2 measures Bivariate predictors of Hernia PF T3 are shown in Tables 2 and 3. In Stage 2 group regressions, the surgical group variables that significantly predicted Hernia PF T3 at p<0.02 were anesthetic and mesh type. In the T1 individual biological and behavioral variables group, BMI and Hernia PF T1 reached the p<0.2 criterion; T1 Pain did not (β=0.004, p=0.97) but as per the analysis plan was forced into the final multiple regression. None of the T1 emotional and cognitive variables met the p<0.2 criterion in the group regression. In the final, hierarchical regression for T1 variables, only Hernia PF at T1 was a significant predictor of T3 Hernia PF (β=0.46, p<0.01). As an individual variable, anesthetic also reached significance such that individuals who received no local anesthesia were more active 18 (β=-0.22, p=0.02) but Model 1, containing anesthetic, was not significant (ΔF = 0.05, p=0.11) (Table 6). Table 6 about here In T2 group regressions, BMI, T2 Hernia PF and Taking Painkiller all maintained significance at p<0.2 in the individual biological and behavioral variable group. T2 Pain did not meet this criterion (β=-0.04, p=0.69) but was forced into the Stage 3 equation as per the planned analyses. When examining the cognitive and emotional variables for multicollinearity, CSQ Control and CSQ Decrease Pain were found to correlate at r>0.7 (r=0.72). CSQ Control had the lower tolerance level and was therefore removed from the group regression. The cognitive and emotional variable that met the criterion to be taken forward from the Stage 2 group multiple regression equation was CSQ Decrease Pain. In the final hierarchical equation, only T2 Hernia PF significantly predicted T3 Hernia PF (β=0.24, p=0.048) (Table 7). Table 7 about here Discussion We used a prospective cohort study design to investigate the contribution of psychological and clinical variables in predicting activity limitations persisting 4 months after inguinal hernia repair surgery. We found that, at four months after surgery, 58% of participants continued to report some degree of activity limitation due to their hernia (50% on more general SF-36 measure of limitations), although levels of activity had increased from before surgery. A bias may have occurred such that participants who were more limited were more likely to respond at four months. However, if the more conservative full sample denominator 19 is considered (135 participants), it is still the case that almost half of the sample report being limited because of their hernia at four months post-operatively (47.4%). Pre-operative predictors of activity limitations (when controlling for concurrent pain) were being older, having a greater degree of pre-existing activity limitations and higher anxiety levels. Post-operative predictors were older age and more depressed mood (marginally significant, p=0.050). Depression predicting later activity limitations is consistent with previous research (Kendel et al., 2010 (a surgical context); Powell et al., 2008 (recovery from stroke)). Only post-operative depression score was predictive – pre-operative depression was not. In participants undergoing surgery on the spine, Seebach et al. (2012) found that post-operative depression (at six weeks) predicted disability at 3 months but pre-operative depression did not. In contrast, Kendel et al. (2010) found depressive symptoms measured pre-operatively predicted activity limitations 2 months post-operatively in individuals undergoing coronary surgery. It might be that the role of depression differs according to the type of surgery. In the case of hernia surgery, individuals may be generally in a good state of health, with low levels of pain and the ability to perform many normal activities. After surgery, these individuals are likely to then experience acute postoperative pain and activity limitation. We assessed depression using the Hospital Anxiety and Depression Scale which asks participants how they have been feeling in the past week. Our post-operative questionnaire was presented one week after surgery, thus individuals were asked to report how they felt in the immediate post-operative period. It may be that it is how a person feels at the start of the recovery process that is important in predicting the recovery of activity, rather than how they feel at a time when the impact of the surgery on the individual is, as yet, unknown. 20 Pre-operative anxiety was a significant predictor of 4-month activity limitation. There is good evidence that higher anxiety before surgery predicts worse post-operative pain, with evidence for its impact on other recovery variables being less clear (Munafò & Stevenson 2001). The present study showed post-operative pain to predict 4-month activity limitations; it may be that anxiety impacted on 4-month activity limitation by increasing post-operative pain. In a systematic review and meta-analysis, Johnston and Vögele (1993) demonstrated that pre-operative preparation techniques designed to reduce anxiety, such as relaxation and procedural information, reduced post-operative pain and also lead to improvements on other health outcomes. The present findings suggest that such interventions may yield benefits for regaining activity in the longer term, as well as in the shorter-term recovery after hernia surgery. As predicted by biomedical models such as the WHO ICIDH model (World Health Organisation, 1980)3, post-operative pain appeared to influence activity limitations at four months after surgery. The presented analyses do not test a second model: that post-operative pain predicts 4-month pain, and it is this 4-month pain that affects 4-month activity limitations. However, in a parallel study with this data set, we found that pain at four months was predicted by lower pre-operative optimism and lower perceptions of control over pain post-operatively rather than post-operative pain (Powell et al., 2011). Future research could usefully examine two mediational models of activity limitation, with either post-operative pain, or 4-month pain tested as a mediator in a predictive relationship between psychological variables and recovery of activity after surgery. In both models, the impact of psychological variables on 4-month activity limitations was a ‘small’ effect (Cohen, 1992). In the context of rehabilitation after hernia repair surgery, 3 The WHO ICIDH model (1980) has been replaced by the ICF model which has a biopsychosocial framework (WHO, 2001). However, the ICF model makes no predictions and so cannot be used as a predictive model. 21 behavior-specific cognitions could be better at predicting activity outcome than the more general and pain-related constructs that are encompassed within fear avoidance models, and the broad construct of optimism. Social Cognitive Theory (Bandura, 1977, 1982) emphasizes the importance of control cognitions – self efficacy – in determining behavior. People who are more confident that they can perform a behavior are more likely to persist with attempts to do so. While it is not inconsistent with this model that someone with higher perceptions of control over their pain would be more likely to persist with an activity, a more sensitive approach to predicting activity would be to ask people about their self-efficacy to do that activity, rather than their self-efficacy in controlling their pain. Avoidance of activity after surgery is not necessarily driven by fear or by focusing on the negative consequences of pain. People may believe (appropriately or inappropriately) that avoiding activity will facilitate and promote more effective tissue and wound healing. In qualitative interviews conducted with people as they progressed through the experience of anticipating and recovering from hernia surgery, we found that participants tended not to be overly concerned about experiences of pain – they regarded pain as a natural consequence of surgery rather than something of which to be fearful (Powell, McKee, King & Bruce, 2013). Pain was sometimes regarded as a marker of when they were doing too much, but the extent to which individuals returned to activity seemed to be associated with the extent to which they perceived the risk that activity could lead to damage at the hernia site. At four months after surgery, we found a dissociation between pain and activity, with some individuals still limiting activity despite being pain-free to ensure that the hernia site was protected, rather than out of pain-related fear or a desire to avoid pain (Powell et al. 2013). These findings suggest that a focus on thoughts and beliefs about activities might be a better predictor of activity outcome in this context than a measure of fearfulness. 22 It has been proposed that combining a biomedical model with a model focused on beliefs about behavior, such as the Theory of Planned Behavior (Ajzen, 1991), will lead to better prediction of activity limitations than the biomedical model alone (Johnston, 1996). The combined model has been found to account for more variance in activity limitations in people with pain, awaiting joint replacement surgery, than can pain severity alone (Dixon, Johnston, Rowley, & Pollard, 2008). Similar findings were seen following surgery (Quinn et al., 2012) and also in community residents (Dixon, Johnston, Elliott, & Hannaford, 2012). With a focus on beliefs about behavior, rather than beliefs and concerns about pain, this may be a useful model in future research investigating psychological risk factors for poor recovery of activity after surgery. While much variance in activity limitations outcome has yet to be accounted for, from current findings there may be value in attempting to identify those individuals who may be at greatest risk of experiencing functional limitations after surgery. As discussed above, pre-operative preparation may be beneficial for those experiencing pre-operative anxiety. Few centers currently implement prolonged treatment or rehabilitation after hospital discharge for minor surgical procedures such as inguinal hernia repair. Older patients with depressed mood might benefit from postoperative rehabilitation to facilitate return to functional activity. Interventions could be targeted to reduce pre-operative anxiety post-operative depressed mood, for example by using brief cognitive behavioral therapy methods (Westbrook, Kennerley & Kirk 2007). Exploratory analyses were conducted with ‘Hernia PF’ as the outcome measure: an as yet unvalidated measure designed to assess activity limitations the participant believes to be specifically due to the hernia rather than all-cause activity limitation. The only variables to significantly predict activity limitations due to the hernia at 4-months were activity 23 limitations pre-operatively and immediately after surgery. Further research on the measure is needed to understand this finding. For example, participants were asked to rate to what extent they were limited ‘by their hernia’; it is unclear whether participants interpreted this as their original, pre-operative hernia, or took a broader view, incorporating the surgical and recovery processes when considering the hernia’s impact on activity limitations. Limitations Our response rate was not high at 39.4%. This might be expected from a postal survey attempting to sample people just as they are preparing to undergo surgery, many of whom are of working age. However, this does limit the extent to which results may be generalized. The comparative analyses between responders and non-responders were encouraging, with the only difference between the groups being a trend effect for non-participants to be younger. Our findings were also limited by the low internal consistency of the optimism measure. We used a brief version of the LOT because of questionnaire length; a fuller questionnaire may be more valuable in this context. It was not possible to use the catastrophizing measure as the authors intended; instead of using it as a continuous independent variable we were obliged to convert this to a binary measure because of the floor effect. The lack of findings for ‘catastrophizing’ may result from this unusual way of operationalizing the construct which may have resulted in reduced sensitivity. However, it may be that, in the context of hernia or post-operative pain, individuals actually tend not to catastrophize, or to catastrophize only at low levels. Our qualitative interviews with individuals undergoing hernia surgery suggested that pain or discomfort was accepted as a natural and expected consequence of having a hernia or having had surgery (Powell et al. 2013). As such, it may be that these individuals 24 catastrophize less in this situation than in contexts where pain is more severe or unexplained, and where the expected timeline for duration of pain is uncertain. Nevertheless, although many studies have reported the incidence of chronic pain after hernia repair surgery, few studies have investigated the risk factors associated with postoperative activity limitations. While activity limitations had reduced at four months compared with before surgery, a large proportion of participants had persistent activity limitations due to the hernia suggesting that further rehabilitation strategies and treatments are necessary to optimize outcomes beyond the immediate short-term. This study explored psychological predictors in a longitudinal approach, adjusting for pain intensity. The rigorous epidemiological design used standardized measures and had a low attrition rate at four months (84% completion). Conclusions Although inguinal hernia surgery is a very common elective procedure, often considered relatively ‘minor’, we found that activity limitations were experienced by up to 58% of participants at four months after surgery. While postoperative pain and surgical factors explained some variance in activity limitations, much variance remained unaccounted for, leaving scope for further research into beliefs about the behavior under investigation. There was some evidence that pre-operative anxiety and depressed mood immediately following surgery predicted poorer activity levels at four months and it may be possible to design interventions to minimize these effects. There is also scope for testing alternate rehabilitation strategies to improve and expedite functional recovery. 25 Acknowledgements This research was funded by a research fellowship to RP at the University of Aberdeen from the Chief Scientist Office of the Scottish Government Health Directorates. 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Acta Psychiatrica Scandinavica, 67, 361-370. 31 Table 1 Data from questionnaire measures (non-transformed data) T1 T2 Median n (IQR) Median (IQR) T3 n Median n (IQR) Pain 4 (1, 7) 135 5(2, 9) 120 -------------- SF-36 PF 80 (70, 95) 131 50 (35, 70) 118 95 (85, 100) 112 Hernia PF 85 (70, 95) 129 50 (30, 66.3) 110 95 (90,100) Anxiety 3 (1, 6) 135 3 (1, 6) 118 --------------- ---- Depression 2 (1, 4) 135 3 (1, 6) 118 --------------- ---- Fear of Movement 18 (15, 20) 131 18 (15, 21) 118 --------------- ---- CSQ Increasing Activity 11.5 (6, 17) 118 14 (9, 17.5) 113 --------------- ---- CSQ Control 4 (3, 5) 123 4 (3, 5) 115 --------------- ---- CSQ Ability to decrease pain 4 (3, 5) 120 4 (3, 5) 106 --------------- ---- Optimism 6 (5, 8) 130 6 (5, 8) 117 --------------- ---- %Y %N 53.0 %Y %N Catastrophizing 47.0 117 51.3 48.7 Taking painkillers ------- ------- ---- 57.8 42.2 %Y ---- 111 %N 113 ------ ------ ---116 ------ ------ ---- Y = Yes, N = No, PF = Physical Functioning. 32 Table 2 Correlations between predictor variables and Four-month (T3) activity limitations measures SF-36 PF T3 (tr) Hernia PF T3 (tr) rs p rs p Duration 0.08 0.45 0.03 0.79 T1 to operation (tr) 0.10 0.28 0.05 0.61 Operation to T3 (tr) -0.09 0.33 -0.15 0.13 Age -0.35 <0.01 -0.03 0.78 BMI -0.17 0.08 -0.17 0.09 Pain T1 (tr) -0.12 0.20a -0.21 0.03 SF36 PF T1 (tr) 0.58 <0.01 0.35 <0.01 Hernia PF T1 (tr) 0.41 <0.01 0.45 <0.01 Anxiety T1 (tr) -0.26 0.01 -0.24 0.01 Depression T1 (tr) -0.29 <0.01 -0.26 0.01 Fear of Movement T1 -0.29 <0.01 -0.23 0.02 CSQ Increasing Activity T1 0.03 0.77 0.01 0.93 CSQ Control T1 0.23 0.02 0.25 0.01 CSQ Decrease Pain T1 0.12 0.24 0.17 0.09 Optimism T1 0.20 0.04 0.19 0.05 Pain (T2 (tr)) -0.27 0.01 -0.30 <0.01 SF36 PF T2 0.34 <0.01 0.35 <0.01 Hernia PF T2 0.31 <0.01 0.43 <0.01 Anxiety T2 (tr) -0.22 0.02 -0.22 0.03 Depression T2 (tr) -0.31 <0.01 -0.22 0.03 Fear of Movement T2 -0.18 0.07 -0.26 0.01 CSQ Increasing Activity T2 -0.07 0.47 -0.10 0.32 CSQ Control T2 0.25 0.01 0.34 <0.01 CSQ Decrease PainT2 0.23 0.03 0.22 0.03 Optimism T2 0.15 0.12 0.05 0.60 Note. tr = transformed; PF = Physical Functioning. Italicization and bold type indicate significance at p<0.2.a: p=0.197. 33 Table 3 Bivariate predictors of Activity Limitations at T3: Mann-Whitney U (p) SF36 PF T3 (tr) Type of surgery U Z 919.5 0.93 629.5 Hernia PF T3 (tr) p U Z p 0.35 966.0 1.44 0.15 0.74 0.46 612.0 0.64 0.52 1309.0 2.27 0.02 1211.5 1.69 0.09 481.0 1.39 0.16 478.5 1.46 0.15 465.0 -0.47 0.64 347.5 -1.70 0.09 672.5 -1.06 0.29 653.5 -1.19 0.24 1141.0 -0.53 0.60 1088.5 -0.75 0.46 1046.5 -1.73 0.08 1163.0 0.79 0.43 948.0 -2.37 0.02 904.0 -2.64 0.01 (0 = open, 1 = laparoscopic) Primary/recurrent surgery (0 = primary, 1 = recurrent) Type of mesh (0 = standard, 1 = lightweight) Uni-/Bilateral (0 = uni-, 1 = bilateral) Anesthetic (0 = no local, 1 = local) Complication (0 = no complication, 1 = complication) Catastrophizing T1 (0 = no catastrophizing, 1 = catastrophizing) Catastrophizing T2 (0 = no catastrophizing, 1 = catastrophizing) Painkillers T2 (0 = no painkillers, 1 = painkillers) Note. tr = transformed; PF = Physical Functioning. Italicization and bold type indicate significance at p<0.2. 34 Table 4 Hierarchical regression equation. Independent variables: T1 variables, baseline measures and surgical variables. Dependent variable: T3 Activity Limitations (SF-36 PF). T3 SF-36 Physical Functioning (tr) Model 1 Model 2 Model 3 β p β p β p Mesh type 0.20 0.05 0.10 0.22 0.11 0.18 Uni/bilateral surgery 0.11 0.26 -0.03 0.75 0.02 0.84 Age -0.19 0.03 -0.21 0.02 BMI -0.15 0.07 -0.13 0.12 SF-36 PF (T1, tr) 0.54 <0.01 0.50 <0.01 Pain (T1, tr) 0.09 0.30 0.17 0.06 -0.24 0.01 0.00 1.00 Anxiety (T1, tr) Fear of Movement (T1) ΔR2 0.05 0.37 0.05 ΔF 2.59 (p=0.08) 14.91 (p<0.01) 4.14 (p=0.02) Note. Model 3: F = 10.07, Adj R2 =0.42, N=101, p<0.001. PF = Physical Functioning; tr = transformed. 35 Table 5 Hierarchical regression equation. Independent variables: T2 variables, baseline measures and surgical variables. Dependent variable: T3 Activity Limitations (SF-36 PF). T3 SF-36 Physical Functioning (tr) Model 1 Model 2 Model 3 β p β p β p Mesh type 0.26 0.02 0.15 0.11 0.13 0.14 Uni/bilateral surgery 0.09 0.41 0.05 0.56 0.09 0.32 Age -0.51 <0.01 -0.52 <0.01 BMI -0.12 0.19 -0.09 0.30 SF36 PF (T2) 0.08 0.44 0.00 0.97 Pain (T2, tr) -0.25 0.01 -0.19 0.05a Taking painkiller -0.18 0.05 -0.11 0.24 -0.20 0.05b 0.14 0.12 Depression (T2, tr) CSQ Decrease Pain (T2) ΔR2 0.08 0.33 0.05 ΔF 3.60 (p=0.03) 9.44 (p<0.01) 3.57 (p=0.03) Note. Model 3: F=7.61, Adj R2=0.40, N=92, p<0.001. PF = Physical Functioning; tr = transformed. a: p=0.046; b: p=0.050. 36 Table 6 Hierarchical regression equation. Independent variables: T1 variables, baseline measures and surgical variables. Dependent variable: T3 Activity Limitations (Hernia PF). T3 Hernia Physical Functioning (tr) Model 1 β Model 2 β p p Mesh type 0.14 0.16 0.14 0.12 Anesthetic -0.17 0.09 -0.22 0.02 -0.14 0.14 Hernia PF (T1, tr) 0.48 <0.01 Pain (T1, tr) 0.04 0.66 BMI ΔR2 0.05 0.22 ΔF 2.29 (p=0.11) 9.70 (p<0.01) Note. Model 2: F = 6.98, Adj R2 =0.23, N=101, p<0.001. PF = Physical Functioning; tr = transformed. 37 Table 7 Hierarchical regression equation. Independent variables: T2 variables, baseline measures and surgical variables. Dependent variable: T3 Activity Limitations (Hernia PF). T3 Hernia Physical Functioning (tr) Model 1 Model 2 Model 3 β p β p β p Mesh type 0.25 0.02 0.13 0.25 0.11 0.30 Anesthetic -0.16 0.12 -0.15 0.16 -0.17 0.11 -0.13 0.22 -0.14 0.18 0.24 0.05 0.24 0.05a Pain (T2, tr) -0.06 0.62 -0.02 0.87 Taking painkiller -0.14 0.21 -0.08 0.47 0.17 0.13 BMI Hernia PF (T2) CSQ Decrease Pain (T2) ΔR2 0.08 0.12 0.02 ΔF 3.67 (p=0.03) 3.00 (p=0.02) 2.41 (p=0.13) Note. Model 3: F=3.25, Adj R2=0.16, p=0.01 N=87. PF = Physical Functioning; tr = transformed; a: p=0.048. 38