Older patients often present with a long, complex history and a clinical picture that frequently includes co-morbidities. It is essential that health professionals caring for older patients become familiar with common age-related changes, and the specific clinical factors that complicate the diagnostic process. A case-based approach is taken in this article to explore the diagnostic challenges in caring for older patients. Three areas of focus are used: a) polypharmacy, b) cognitive issues such as delirium, dementia and depression, and c) increased odds of pathologies and chronic illnesses. One of the greatest challenges in caring for older adult patients is formulating an accurate and appropriate diagnosis ,2. OlderThe fastest growing subset of the US population is the 75+ age category  and currDue to this confluence of an aging world and the complex nature of geriatric health, it is essential that chiropractors thoroughly assess their older patients for concomitant health issues that may impact clinical decision making and patient prognosis. In this article a case-based approach will be taken to explore several important clinical problem solving examples. These cases are fictitious, based on an amalgam of previous clinical experiences, therefore no IRB or ethics approvals were required. The focus will be on three major confounding areas that create diagnostic challenges in managing older adult patients: Polypharmacy, cognitive issues, and increased risk of a co-morbid pathology or chronic illness.In spite of the frequency in which chiropractic patients present with a musculoskeletal pain complaint, there is no doubt that common age related changes impact older patients profoundly. Such changes include :➢A decline in all five senses ➢Lower muscle mass, bone density, and ligament elasticity➢Some amount of atherosclerosis➢Increased risk of co-morbid conditions ➢Greater likelihood of chronic disease, like heart disease and arthritis,➢Potential cognitive changesIt is with these changes in mind that examination of older patients should occur with a heightened vigilance for co-morbid conditions that may require medical care or concomitant care. One goal of a health professional in geriatric care should be to identify the diagnosis or to have a high index of suspicion of an important health concern.Sophie, age 80, has a little cold. She takes an over the counter fizzy tablet [as she describes it] She reports that it helps with her cold symptoms. Unfortunately, last night Sophie got up to go to the bathroom and she got dizzy and fell. She comes to see you because she twisted her back and hurt her wrist in the fall. A careful examination strongly suggests that Sophie did not break any bones, and her aching back and wrist appear to be simple strains. The dizziness concerns you, so, you ask a local pharmacist if the cold medication she took the night before may have dizziness as a side effect. The pharmacist cautions that this particular medication can increase the risks of falls in older patients. She suggests several alternate over the counter medications that would be safer for Sophie. Subsequently, you may manage this patient with gentle chiropractic care, if indicated.""According to Healthy People 2020, polypharmacy is the principle drug safety issue in the US, particularly in older patients . PolyphaIn the USA adverse drug events cause over 700,000 emergency department visits each year. Nearly 120,000 patients [all ages] each year need to be hospitalized for further treatment after emergency visits for adverse drug events. As more and more people take more medicines, the frequency of adverse events may increase. Older adults [65 years or older] are twice as likely as others to come to emergency departments for adverse drug events  and nearly seven times more likely to be hospitalized after an emergency visit ,24,25. CSeveral resources are available related to medication information ,24-26. Cacute confusion is fairly common in older adult patients and may be frightening for both chiropractor and patient. Delirium is common and is a transient state, and nearly always resolves once the cause is determined and underlying issue is addressed . A call is made to the prescribing doctor, and George is given the first available appointment. After a medical review and a change in the medications, George is back to his old self again in a few days and Bill is glad to have his brother back.One of the most common causes of delirium is medications. Both over the counter medications and medications taken as prescribed may become toxic in older patients, resulting in confusion ,28. The You witness a minor car accident up ahead, so you stop to see if anyone was hurt. An older gentleman rear ended a man in his 30’s who appears to be very upset about the damage to his newer car. He approaches the older driver angrily as you peek into the driver’s window. Hugh, who looks to be in his 80’s is looking around nervously in the car and fumbling with the door. You help him to open the door and you see that he has a bad cut on his forehead. He’s bleeding and when you ask him if he is okay, he speaks unintelligibly, something about a horse and then says he has to get some milk. He gets out of the car with some unsteadiness then starts to walk out into the street, despite oncoming cars. When you try to stop him, he curses and takes a swing at you.""Acute injury may result in acute confusion. For example, a minor bump on the head may result in delirium, and create a confused and maybe even violent and unpredictable patient. It is essential to get immediate emergency treatment for an injured older adult, and to be aware that acute confusion will regress once the injury is resolved. Patients who present for chiropractic care due to a musculoskeletal injury may be difficult to properly assess due to delirium.Bill’s family is concerned. Bill, at age 75, is normally a mentally sharp man. Lately, however, Bill seems confused and has also been complaining of a “back ache” for 2 weeks. During your history and exam, you determine that he has had no change in medications, and no recent injury, however Bill’s back pain seems to be more than just musculoskeletal pain. He has an achy vague pain in his back, pelvic area and lower abdomen. Since he is over 50, with a high fat diet, and has a family history of prostate cancer, you know he is also at increased risk for prostate cancer. Even though you had encouraged him to have a baseline Prostate Specific Antigen [PSA] blood test and prostate exam several years ago, he has not had one for years. You ask the related history questions: “Do you have any changes in urination, defecation or sexual function?” His wife, who is in the room with Bill, chimes in, reporting that Bill has been getting up to urinate several times a night, which wakes her up. Bill confesses to having some burning and frequency of urination. Urinalysis reveals a bladder infection, so you inform Bill and his wife and send a copy of Bill’s urinalysis results to his doctor. The doctor requests to see Bill that day, and Bill’s wife takes him in. One day after Bill starts taking his antibiotics, his urinary frequency and pain is resolved, along with the supra-pubic pain. His wife calls to tell you his confusion has completely gone away.""A simple bladder infection or respiratory infection may have a unique presentation in elderly patients. In fact, all other symptoms may be eclipsed by the erratic, confused behavior. In the case above Bill had a simple bladder infection, secondary to benign prostatic hypertrophy [BPH]. It is important to note that an estimated 50% of men demonstrate histopathologic BPH by age 60 years. This number increases to 90% by age 85 years . MissingDementia is a collection of symptoms including slow, gradual onset memory loss, intellectual impairment, loss of emotional control and problem solving ability. One type, Alzheimer’s Dementia [AD] leads to a progressive loss of mental functions, and often includes disruption of speech or difficulty finding words -32. It iHenry, age78, has been your patient for a decade, but you have noticed his mental sharpness has been in decline over the past few years. He remarks that he got lost coming to your office today, and he confesses that he got lost going to the grocery store twice in the past 2 months. As he speaks, he verbally wanders and seems to have difficulty finding the words to complete his sentences. He says he has good and bad days, but lately there have been more and more bad days. Henry becomes emotional as he tells you for the second time about getting lost today. He is noticeably shaken up. Henry has a history of cardiovascular health issues and does little, if any, physical activity.""While a chiropractor can potentially treat Henry for his musculo-skeletal problems, medical oversight is required to further assess his dementia. It is essential that his cardiac health be monitored, so it is important for the chiropractor to regularly take blood pressure and to make certain that Henry is regularly consulting his medical physician. Dementia can be devastating for both patient and family, so it is important that the family identify resources related to dementia such as the Alzheimer’s Association (USA) .Depression is a common mental health concern in older adults. One in 5–10 elderly adults suffer from depression and 80% of all depression is completely treatable, once detected. Detection is of utmost importance since suicide is one of the top 10 causes of death in older patients . SuicideIt is important that all health professionals caring for the older adults be aware of the diagnostic criteria for depression . FurtherAccording to World Health Organization statistics, heart disease is the number one cause of death worldwide, accounting for 7.2 million deaths annually . CerebroThe case below will illustrate why heart disease should be on the mind of chiropractors every day in practice. Nearly all chiropractors, if they are in practice long enough will have a patient present for chiropractic care while they are having a heart attack. It is essential that chiropractors be good diagnosticians, so as to avoid a delay in emergency care for patients experiencing a cardiac event.Inez is 65 years old. She cares for 3 of her grandchildren at home on a regular basis, getting two of them ready for school, and one to day care each morning. One morning, in the midst of her busy routine, Inez started feeling queasy and uncomfortable. By the time she dropped the 3rdchild off at daycare, Inez also started having neck and jaw pain. She headed straight to your chiropractic clinic, as she has been a patient there before for her occasional neck pain. Today, you examine her and decide to take her blood pressure and pulse since her blood pressure has increased over the past few years and she reported last year that her doctor had mentioned that she may need to go on medication. She is not currently taking any anti-hypertensives, but is taking oral medications for type 2 diabetes. Her blood pressure was high [150/100] and her pulse was fast. In evaluating her neck and jaw, movement did not make it worse. You ask her to march in place with high steps for 1 minute to see if exertion makes it worse, and sure enough, she has to stop due to “feeling sick”. You call for emergency services and arrange an ambulance. Inez was having a heart attack, and she calls you once she is out of the hospital to thank you for “saving her life.”""Heart attacks in women don’t always follow the rules. Heart attacks, after all, are supposed to present as crushing chest pain, and left arm pain. But, female heart attacks often result in vague pain, no pain, discomfort or just an uneasy feeling . While aAmong older adults, back pain is one of the leading causes of a trip to the doctor -10. It iIt is beyond the scope of this article to point out the specifics of care and assessment of patients with back pain, but excellent literature has been presented elsewhere including in this journal’s series on the elderly.For many younger patients, musculoskeletal pain may be a simple as a sprain or strain, including the common presentation of uncomplicated back pain ,13-15. I1. Arthritic changes2. Spinal stenosis [narrowing of the vertebral canal]3. Osteoporosis with possible compression fractures4. Pathologies 5. Organ dysfunction causing back pain symptoms The table below indicates some of the incidences of common health concerns in older adults using the United States as an example -43:All of these disease processes are more likely in the older adult -45. ThesThe odds of pathology are higher in the older patient than in any other age group. Sixty per cent of the metastases to the spine are from the prostate [almost exclusively in patients over 50] and another 25% of metastases are from the lung [also more common in older patients with a history of smoking.] Breast cancer metastases to the spine are also predominantly seen in older patients ,45.Recent imaging prior to initiating manual therapy for older patients may be useful to avoid damaging anatomical structures that contain underlying pathology. Although the definition of “older” in the case of routine imaging is controversial, with some now recommending 65 and older as the age of concern for low back pain . Incidenhttp://www.nia.nih.gov[http://www.healthinaging.org/agingintheknow/[In this article we have explored just a few cases that highlight the diagnostic challenges in the older adult patient. As the baby boomers reach their golden years, it is essential that all health professionals learn more about normal aging, and common health related concerns in older patients. Excellent resources for providers are available at the National Institute on Aging at a.nih.gov and the ntheknow/ These anThe author declares no competing interests or financial interests.


There are several guidelines dealing with the management of low back pain (LBP), but only few studies on the quality of care provided within General Practices as judged against those guidelines.The objective of this study is to analyse the management of LBP in Italian General Practice and compare it with guideline recommendations.In this observational study, all patients visiting their General Practitioners (GPs) for treatment of LBP within a 8-week period were monitored for at least four weeks with regard to symptoms and diagnostic and therapeutic interventions. Management of LBP was judged by pre-defined quality indicators based on guideline recommendations.Twenty-five of 114 eligible GPs participated in the study, representing a total of 43,012 registered patients. Of the 475 patients complaining of LBP and monitored for four weeks, 55.8% were diagnosed as having acute lumbar pain, 13.5% chronic lumbar pain, 17.1% acute sciatica, and 12.6% chronic sciatica; 76.0% underwent no technical investigations, 21.7% underwent x-rays, 5.5% MRI and 4% CT scans; 20.4% were referred to secondary care; 93.3% of all patients received some medication. In those receiving a medication, in 88.3% it was an NSAID, in 6.3% Paracetamol, in 10.4% Paracetamol combined with Codeine, and in 9% a muscle relaxants. When physiotherapy was prescribed , it was mostly massage. Hardly more than 50% of GPs  followed locally established guidelines, while the remainder seemed not to follow guidelines at all.Our study reveals gross deviations of GP management of LBP from current guidelines and points to two different types of deviators: those who partially follow guidelines, and those who do not follow them at all. Further research should evaluate whether these two types of deviation are best addressed by different foci of education, i.e. on knowledge versus attitudes, respectively. Low back pain (LBP) is a common ailment among patients visiting GPs . The annHowever, there is still a lack of available data from primary care sources on the epidemiology of care for LBP -24.The aim of this paper is to show how LBP is managed within Family Practices in a gate-keeper system in South Tyrol in Northern Italy, focusing on diagnostic investigations and treatment, and comparing these procedures to actual guideline recommendations.every LBP patient consecutively visiting the practice. Additionally, GPs were phoned three times in this period of eight weeks to support a complete inclusion of all eligible patients.For this observational prospective cohort study, all 114 General Practitioners (GPs) based in Bozen  and the surrounding rural area were invited by post to participate. They were informed that this would include the monitoring of all patients coming in for LBP treatment during a defined period of time , and that they would receive 30 euros per patient. This “pay for inclusion” system was designed to ensure that the GPs taking part would include To be recruited to the study, GPs had to be working for at least four years in a practice so as to confine the study to the more experienced GPs, and thus arrive at a conservative estimate of guideline adherence. Financial constraints limited our sample to the first 25 GPs who applied to take part and fulfilled the inclusion criteria.All patients were monitored and documented by GPs for at least four weeks following their inclusion in the study. We report here data obtained in the first 4 weeks of monitoring of the included patients. For a subset of patients that we were able to monitor for at least 9 weeks (n = 198), we report the number of further visits with their GP.A more detailed account of the study methods and its epidemiological results has been reported elsewhere .The participating GPs were provided with the following definitions:Low back pain: Back pain from the low costal arch to the gluteal muscles which is not caused by any secondary condition .Acute low back pain: Pain lasting less than 12 weeks, or recurring LBP following a pain-free interval of at least 6 months.Chronic (recurring) low back pain: Pain lasting 12 weeks or longer or recurrences within less than 6 months.Lumbar pain: No neurological (senso-motor) deficits; Pain does not radiate below knee; pain not restricted to a specific dermatome.Sciatica: Dermatome-related pain to area below the knee; often more intense than in the lumbar region; pins and needles or numbness; occasional muscular weakness; reduced reflexes.Complex LBP (“red flags”): senso-motor deficits; pain due to tumour, metastasis, fracture or infection.included if they visited the practice with eitherPatients aged at least 18 years were to be a) acute LBP orb) chronic (recurring) LBP.excluded. Patients whose LBP was caused by a malignancy or fracture  were also excluded whenever this was detected, partly to arrive at a relatively homogenous sample and partly because this subgroup was expected to be very small, not allowing a subgroup analysis for these patients.Patients who had received treatment for their current condition prior to the study were GPs were issued a specifically designed questionnaire (spreadsheet in excel format) in which they documented each patient’s sociodemographic baseline data, type of LBP, pain level on a scale of 1 to 10 (score elicited from the patient), diagnostic procedures, therapeutic interventions and any referrals to secondary care. The questionnaires were to be filled out, at baseline and at each further visit. In order to keep workload low and participation / compliance high, GPs were only asked to document the patients they included. Naturally, patients with unobvious “red flags” were initially documented but excluded in the later course whenever the “red flags” became apparent.proportion of quality indicators reached). This assessment instrument follows the principles of “pay-for-performance” systems in use in the UK and discussed for example by the American College of Physicians [In order to define the extent to which GPs complied with guidelines, we developed an assessment instrument based on the main diagnostic and therapeutic recommendations  of the two guidelines in local use ,17. We aysicians .Our assessment instrument was based on the following five quality indicators and the required percentage of patients who should receive the care proposed:acute lumbar pain no more than 10% of patients should undergo an X-ray during their first visit.1 For acute sciatica no more than 10% of patients should undergo an X-ray, CT and/or MRT during their first visit.2 For lumbar pain or sciatica no more than 10% of patients should be referred to an orthopaedic specialist or neurosurgeon during their first visit.3 For lumbar pain or sciatica no more than 5% of patients should be given an intramuscular injection of a NSAID.4 For lumbar pain or sciatica not less than 30% of patients should be prescribed paracetamol alone or in combination.5 For Data are presented as percentages, while groups were compared using chi-square Pearson test. Statistical analyses were performed with STATA for Windows 10.0 .In Italy it is not necessary to secure ethical approval for the analysis of pseudonymized administrative data.Of the invited 114 eligible GPs in this region, the first 25 GPs applying for participation were chosen. They served a total of 43,012 registered patients. On average, there were 1,720 registered patients per GP . Responder analysis of the 25 participating GPs compared with the residual 89 GPs showed no difference with regard to gender, age, years of experience, or number of registered patients (data not shown).During the initial eight-week period, the 25 GPs recorded the visits of 487 patients complaining of LBP as defined by the inclusion criteria. In the course of the diagnostic workup, 2 patients with malignancies and 10 suffering from osteoporotic fractures had to be excluded from the sample (see exclusion criteria). The remaining sample (n) of 475 patients was monitored for the subsequent four weeks. Each GP enrolled on average between one and five patients per week.The average age of these patients with LBP was 55,3  years, and 57% of them were female. Overall, 72.5% of patients with LBP saw their GP only once within the initial four-week period, 22.3% visited twice, and 5.2% three times or more. In a subgroup of patients whom we were able to monitor for at least nine weeks (n = 198), only 16% visited their GPs again in the additional five weeks adjoining the 4 weeks monitoring period for all patients.Of the 475 patients 265  were diagnosed with acute lumbar pain -and 64  as chronic lumbar pain; 81 (17.1%) were diagnosed as acute and 60 (12.6%) as chronic sciatica, 5 (1%) were missings.Pain was assessed by the patient using an NRS . At the time of the first visit the average level of pain was 6.0 . Patients who visited their GP only once, i.e. at the first contact, rated themselves on average at a non-significant slightly lower pain level (5.6 on the NRS) than the rest of those who visited the GP several times. Of the 131 patients who saw their GP more than once during the four-week follow-up, the average level of pain fell to 3.2  over the period between first and second visit.Seventy-six percent (n = 361) of all patients received no technical (including laboratory) investigations during the four-week follow-up period. 21.7% underwent an x-ray, 5.5% an MRI scan and 4% a CT scan. Few patients received many tests; in those getting at least one test, the average number of tests was 1,2 .20.4% of the patients were referred to secondary care: 11.6% to an orthopaedic surgeon; 6.5% to a neurosurgeon, and 2.3% to a specialist doctor for physical therapy .acute sciatica (49.4%) were referred to secondary care and/or received diagnostic interventions than those with acute lumbar pain . The same trend held for chronic LBP when sciatica and lumbar pain were compared (data not shown).There were a number of differences between treatments of the two differential types of low back pain (lumbar vs. sciatic) with regard to diagnostic interventions and referrals Table . Signifiwith acute lumbar pain. Overall, 14% (37/265) of patients with lumbar pain were referred for an x-ray during their first consultation, but six GPs referred more than 20% (17/52) of their patients during the first consultation, including one who requested x-rays for 57% (3/5) of his patients. Five GPs, on the other hand, did not request an x-ray at all (0/30), and another five requested x-rays for fewer than 10% (5/84) of their patients (p = 0.004 for variability).A striking discrepancy among individual GPs was found in terms of referring patients The average levels of pain recorded by patients across all practices were statistically similar among these groups (data not shown).sciatica received a CT scan in 7.9% (6/81) and an MRI scan in 6.1% (5/81) of cases after the first consultation.Compared to patients with acute lumbar pain , patients with acute The discrepancies among GPs concerning the care of sciatica patients seemed remarkable: 15 did not refer any patients for a CT scan (0/38), while five did so in more than 30% (4/11) of cases during the first consultation; however, these differences did not reach statistical significance (p = 0.290). The average levels of pain among these two groups were statistically similar (data not shown), so differences in pain levels do not explain these discrepancies. Twenty GPs did not request an MRI scan for any of their patients (0/65), but five sent almost a third  of their patients with sciatic pain for an MRI scan (p = 0.063).Only 17.1% of all patients received any form of physical therapy. Of these, massageconstituted two thirds of all prescriptions for physiotherapy, significantly more than prescriptions for regulated exercise.Only 6.7% of all patients were prescribed no medications at all within the four-week monitoring period. Of those patients who were prescribed at least one medication, 88.3% received an NSAID, 6.3% paracetamol, 10.4% paracetamol in combination with codeine, 9% muscle relaxants, 5.2% steroids and 2.9% tramadol (Table acute sciatica were prescribed steroids (p < 0.05) and tramadol (p < 0.05) than patients with acute lumbar pain. The prescription rate of NSAIDs did not vary significantly (p = 0.71). 17% of patients with acute sciatica were prescribed muscle relaxants  in more than 50% of all cases while another eleven GPs prescribed it in less than 10% of their patients (p =0.000).In 25.6% of all patients receiving NSAIDs at the first consultation these were administered as an intramuscular injection. A number of these patients received repeated injections. There were differences in the route of administration within each category of LBP. Patients with chronic LBP were much less likely to receive an intramuscular injection than those with acute symptoms (p < 0.05). Four GPs provided no intramuscular injections at all, while five others used this as the preferred application (more than 50% of primarily given NSAID) Table . Many GPnon-compliant with the guidelines.In applying our pre-defined assessment instrument in order to summarise the quality of care (see Methods), it was found that among the 25 participating GPs, three failed in all five of the quality indicators, and eight failed in four of them. We denominate these 11 GPs as fully compliant.The two GPs fulfilling all five quality indicators were denominated as intermediate in terms of their compliance with the guidelines (N = 12). The groups of fully or intermediately compliant GPs compared to those termed non-compliant did not differ significantly with regard to the following characteristics: age and gender of both GPs and patients; patients’ pain-scale scores, and number of patients cared for by a GP (data not shown).Another four GPs fulfilled three of the five quality indicators, and eight fulfilled just two. These were denominated as This study among a sample of 475 patients consecutively consulting their South Tyrolian GP with LBP demonstrated that hardly more than half of the participating GPs were likely to follow local guidelines on LBP whereas the other half seemed not to follow guidelines at all. For example, 21.7% of all patients underwent x-rays, 20.4% were referred to secondary care, and of the 93% who were prescribed medication, 88% received NSAID whereas the first-line recommendation paracetamol was given in only 10%.Our study confirms that in the studied group of GPs and their patients, repeated visits in the following month after consultation for low back pain are the exception rather than the rule. Other studies within General Practice have found higher rates of second or third consultations ,8,26. BuThe finding of low re-visiting rates suggests “minor” LBP episodes. But the opposite seems to be the case: The percentage of sciatica cases within the total number of patients with LBP is remarkably high (nearly 30%). Other studies have reported a much lower occurrence of sciatica, sometimes only 5% . But theThe constellation of low re-visiting rates on the one hand, and the high rate of sciatica (i.e. complicated LBP) on the other, is relevant to the interpretation of our results with regard to diagnostic and treatment measures. Considering the two relevant guidelines on LBP in local use, these findings make over-treatment more likely than under-treatment.acute lumbar pain and 16.7% with acute sciatica were referred for an x-ray during their first consultation. In addition, referrals for CT or MRI scans were requested in 7.9% and 6.1% respectively of the acute sciatica cases during the first consultation, which is also higher than expected, judging by the guidelines based on the epidemiology of symptomatic acutely-slipped discs truly warranting radiological imaging.In line with current guidelines, 76.0% of the study patients were not referred for technical diagnostic investigations. However, contrary to these guidelines, 14.3% of patients with Only a few GPs prescribed paracetamol, even though all guidelines in local use ,17 recomFurthermore, three quarters of all patients with low back pain received an NSAID. Most of those with high pain levels received intramuscular injections, which is not recommended in guidelines. One possible explanation for this adherence to obsolete treatment procedures is – referring to the results of a previous study in Germany  – that GWe identified five other studies on the treatment of LBP in general practice, employing a retrospective or prospective approach. One from Germany  had a hiApproximately half of the participating GPs in our study treated their patients more or less according to the guidelines, while the remainder provided care that was hardly or not at all compliant with local guidelines. In particular, some GPs relied too much on diagnostic imaging  during the first consultation – even for those patients who only suffered from lumbar pain. We also find this trend in the other studies cited above, but mostly to a lesser extent. Possible explanations include the wide time spans between the above cited studies and the different medical cultures within the countries where the studies took place.The other main finding of our study was that paracetamol was not prescribed often enough either alone or in combination with codeine, a phenomenon also found in the other five studies.Our study was unique in identifying the relatively high percentage of intramuscular NSAID injections prescribed. The other German study  did not Our finding that guidelines were not being followed could represent a more general scepticism on the side of the GPs towards guidelines, particularly in the area of LBP where more individualized care may be assumed to be necessary ,29. HoweThis observation suggests that the cultural concept or notion of LBP should be considered when compared to heart failure, for example. In most cases LBP cannot be regarded as the result of concrete physical injury – except “stress and strain”. Some authors regard LBP as a psychosomatic and culturally defined condition, or at the very least as an illness strongly influenced by psychosocial factors . AdditioIf this were true, a merely rational approach– as stipulated in the guidelines – is not sufficient to change the doctors’ behaviour. Rather, an approach that focuses more on the emotional aspects of the relationship between patient and doctor would seem more promising. Thus, we suggest evaluating educational interventions aimed at encouraging doctors to address perceived pressures and anxieties openly and to inform patients about the benign nature of the condition. In an interventional study aimed at changing the behaviour of GPs prescribing antibiotics for acute cough, such an approach was shown to be effective .all patients seen by their GPs in an attempt to reduce any selection bias. Another strength is the decision to provide criteria to GPs beforehand that defined the different kinds of LBP. Moreover, thanks to an intense data monitoring, rigorous phone tracking in case of missing data, and an extraordinary commitment of the participating physicians who know each other and cooperate well in this small community of GPs in South Tyrol, we achieved a high data quality (few missing data).One of the study’s strengths comes from our efforts to include One obvious limitation is that, due to financial constraints, our system of enrolling GPs – taking on only the first 25 who applied and fulfilled the inclusion criteria – could have favoured those who were most interested in the subject matter of our study and thus created a bias. Despite this, our results hardly draw a picture of perfect GPs happily following guidelines, and this probably suggests that in reality the average GP deviates even further from guideline recommendations than our findings suggest.Also, we cannot know for sure that the GPs included all consecutive patients with LBP. However, we did not attempt to control the inclusion process since we felt that this would be too much interference, if at all feasible, and eventually counter-productive.Further, our assessment instrument described in the Methods section was not a validated instrument since we could not identify one at the time. However, we found it to be a pragmatic and transparent approach for providing insights into what we consider the “right” or “wrong” courses of action, and it gives an approximate assessment of whether guidelines are followed. Its main shortcoming is that it fails to address questions relating to whether each individual patient is receiving the optimal treatment. But that would be difficult to judge without all the patients being seen again by a qualified “controlling physician” who could bring together the individual clinical situation with the corresponding recommendations of the study physician.Another limitation of our study is that we were only able to assess compliance to guidelines using plausible assumptions  and were therefore unable to analyse on the basis of individual “cases”.Our study reveals gross deviations of GP management of LBP from current guidelines, resulting in likely over-diagnosis with imaging techniques, over-treatment with NSAIDs, and over-utilisation of an obsolete mode of NSAID application, i.e. intramuscular injection. All three guideline deviations are potentially harmful.The data point to two different types of deviators: those who partially follow guidelines, and those who do not follow them at all. Further research should evaluate whether these two types of deviation are best addressed by different foci of education, i.e. on knowledge versus attitudes, respectively.CT: Computer tomography; GP: General practitioner; LBP: Low back pain; MRI: Magnetic resonance imaging; NSAID: Non-steroidal anti-inflammatory drugs.The authors declare that they have no competing interests.GP participated in the design, was the leading researcher in South Tyrol realizing the study and its data-analysis, and worked on the publication. AE arranged for the funding, participated in the conception and worked on the publication. DG worked together with GP on the realization of the study in South Tyrol. ES gave statistical advice and analysed data statistically. JidS participated in the conception of the study, contributed to the draft and finalised the manuscript. HHA conceived of the study, participated in its design, supervised both execution and analysis, and helped to draft the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2296/14/148/prepub


P < 0.001 and 1.64 (1.02–2.65), P = 0.041, resp.). Fear of addiction was a greater barrier for those with OUDs as compared to those with non-opioid SUDs (OR (95% CI): 2.12 (1.04–4.30), P = 0.038) and no SUD (OR (95% CI): 2.69 (1.44–5.03), P = 0.002). Conversely, participants with non-opioid SUDs reported lower levels of worry about reporting pain to physicians than those with no SUD (OR (95% CI): 0.43 (0.24–0.76), P = 0.004). Participants with OUDs reported higher levels of worry about reporting pain than those with non-opioid SUDs (OR (95% CI): 1.91 (1.01–3.60), P = 0.045). Concerns about side effects and fear of addiction can be barriers to analgesic use, moreso for people with SUDs and OUDs.Attitudinal barriers towards analgesic use among primary care patients with chronic pain and substance use disorders (SUDs) are not well understood. We evaluated the prevalence of moderate to significant attitudinal barriers to analgesic use among 597 primary care patients with chronic pain and current analgesic use with 3 subscales from the Barriers Questionaire II: concern about side effects, fear of addiction, and worry about reporting pain to physicians. Concern about side effects was a greater barrier for those with opioid use disorders (OUDs) and non-opioid SUDs than for those with no SUD (OR (95% CI): 2.30 (1.44–3.68),  Chronic pain is commonly encountered in primary care , where tSeveral patient characteristics have been associated with attitudes that may result in more barriers to the use of analgesic medications  including non-White race, lower education, more physical symptoms , older aOur objective was to compare attitudinal barriers to analgesic use among patients with SUDs and those without, across three domains: concern about side effects, fear of addiction, and worries about reporting pain to physicians. We hypothesized that the majority of primary care patients with SUDs would have moderate-to-severe attitudinal barriers and that those with SUDs would have greater barriers in all three domains as compared to those without SUDs. We also explored whether two subcategories of SUDs—(1) current versus lifetime disorder and (2) OUD versus nonopioid SUD—report greater barriers. We hypothesized that people with lifetime SUDs as compared to current SUDs, and OUDs as compared to nonopioid SUDs, would have greater barriers in all three domains. We conducted a cross-sectional study of a sample of primary care patients with chronic pain. We recruited participants between February 2005 and August 2006 from waiting rooms of an academic, urban hospital primary care practice. We approached patients waiting for appointments and included patients who were 18–60 years of age, spoke English, had pain for three months or more, reported use of any analgesic medication (over-the-counter or prescription) in the prior month, and had a scheduled primary care appointment. Informed consent was obtained from eligible patients. Trained interviewers administered surveys. We compensated participants with $10. The Boston University Medical Center Institutional Review Board approved the study, and a certificate of confidentiality was obtained from the National Institutes of Health.The dependent variables of interest were the Barriers Questionnaire II (BQ-II) subscale scores. The BQ-II, a validated 27-item self-report survey, was originally designed to measure barriers to obtaining pain relief for cancer patients . We seleThe main independent variables of interest were mutually exclusive categories of substance use disorders identified using the Composite International Diagnostic Interview v. 2.1 Drug Use Disorder module, a well-validated interview instrument that yields current and past DSM-IV diagnoses , 21.We assigned participants into three mutually exclusive categories of substance use disorders: those with “OUDs” (which included opioid abuse and dependence), “nonopioid SUDs”  and no SUD. If a participant met criteria for more than one substance use disorder and one was opioids, we categorized them as “OUD.”We adjusted analyses for factors known to be associated with attitudinal barriers to analgesic use , 13–15, We compared the proportion of participants with moderate-to-significant barriers in each category of SUD using chi square analyses.We conducted a sensitivity analysis to examine the relationship between the nonmutually exclusive categories of lifetime (includes both current and past) and current SUDs, and prevalence of moderate-to-significant barriers. Because we did not detect large differences, we used lifetime disorders only for subsequent analyses.We conducted bivariate analyses using general linear models with the Duncan multiple range test for differences to examine the relationship between the independent variable of interest , and the BQ-II subscale scores. Because the three categories differed in their relationship to BQ-II subscale scores (data not shown), we maintained this variable as a three-part variable in further analyses.In bivariate analyses, the main independent variable impacted the subscales in opposite directions. We therefore examined the subscales separately. We first conducted bivariate analyses to examine the relationship between covariates and the barrier subscales. We then constructed three multivariable logistic regression models—one for each subscale—in order to examine the relationship between substance use category  and the odds of having moderate-to-significant barriers. Each model was adjusted for the main independent variable and all covariates. Tests for colinearity among the covariates were carried out using correlation coefficients and any colinear variables were eliminated.P = 0.04), less likely to take over-the-counter pain medication , and more likely to take opioid pain medication .Of 822 eligible patients, 597 (73%) enrolled and completed the research interview. Enrollees were more likely than those who declined enrollment to be black  and no SUDs . Participants with nonopioid SUDs less often reported moderate-to-significant worries about reporting pain to physicians than those with no SUDs .In the full sample, moderate-to-significant fear of side effects (60%) and concern about addiction (71%) were common while worry about reporting pain to physicians was relatively uncommon (27%). Participants with OUDs more often reported moderate-to-significant fears of addiction than those with no nonopioid SUDs , fear of addiction (83% versus 78%), and worries about reporting pain to physicians (23% versus 18%)).Unadjusted logistic regression analyses of moderate-to-significant barriers comparing substance use groups are presented in Multivariate logistic regression analyses of moderate-to-significant attitudinal barrier subscale scores among participants with OUDs, nonopioid SUDs, and no SUD are also shown in In our sample of 597 primary care patients with chronic pain, moderate-to-significant fear about side effects and concern about addiction was common, and more so for participants with OUDs and nonopioid SUDs than those with no SUDs. Conversely, moderate-to-significant worries about reporting pain to physicians were less common overall, and less so for participants with nonopioid SUDs. In adjusted analyses, participants with OUDs reported more concern about side effects and fear of addiction yet similar worries about reporting pain to physicians as those with no SUD. Participants with nonopioid SUDs reported lower worries about reporting pain to physicians than those with no SUD and those with OUDs. Interestingly, those with current and lifetime substance use disorders reported similar barriers with regard to all three subscales.Why might people with OUDs and chronic pain report a greater degree of attitudinal barriers to analgesic use than participants with nonopioid SUDs? In our study, there were no differences in baseline characteristics between those with OUDs and those with nonopioid SUDs, which suggests that there is something about the experience of the opioid itself  that is associated with increased barriers. Because relapse or worse addiction may be triggered by exposure to opioid medications, those with OUDs may have heightened concern compared to those with nonopioid SUDs, who may perceive less risk of addiction with exposure to opioids. This finding is consistent with other studies showing that HIV-infected patients with a prior injection drug use history are more concerned than their noninjection drug using counterparts about the addictive potential of pain medications .Greater attitudinal barriers among participants with OUDs are particularly interesting because this observation is in contradiction to the experience of many clinicians who describe patients with pain and opioid abuse as “drug seeking” . In factThe finding that attitudinal barriers were similar for those with current and lifetime opioid use disorders suggests that patients with past SUDs may harbor as many negative attitudes regarding concerns about side effects and fear of addiction potential as patients currently struggling with opioid addiction. This caution about taking pain medications in patients with past SUDs and chronic pain may be appropriate. While opioids may provide good short-term pain relief, chronic opioid use can produce a number of problems, including relapse . HoweverWhy might individuals with SUDs have lesser attitudinal barriers to reporting pain to doctors than individuals without SUDs? Patients in this study all suffered from chronic pain and may therefore have developed a certain level of comfort discussing pain. In addition, patients in our study also had ongoing relationships with regular primary care clinicians, a key characteristic identified by patients as essential to good communication and clinical decision making . FinallySeveral limitations apply to our findings. The sample was derived from a single academic urban hospital primary care practice and is therefore potentially subject to idiosyncratic practices, which may limit its generalizability. Nonetheless, the sample reflects a demographically heterogeneous group and is likely similar to patients in many other urban primary care practices in the US. In addition, the questions focused on possible side effects, addiction potential, and reporting of pain, and not about attitudes towards requesting or receiving prescriptions for opioid pain medications. Thus, we may have missed the potentially contentious part of the medical encounter: namely, the dispensation of opioid prescriptions. Finally, the questions did not explicitly delineate which classes of pain medications  to consider. We expect that most participants assumed questions were referring to opioid medications; indeed recent opioid prescription was common in our sample, suggesting that many participants had experience with prescription opioids.Despite these limitations, the study offers a preliminary look into the nature of patient attitudinal barriers to analgesic use in primary care patients with pain and addictions. It also offers an alternative perspective on patient-physician interactions than that previously described. Prior studies have demonstrated that the patient-physician interaction regarding pain medications is characterized by mutual mistrust and difficult communication . PrimaryIn summary, patients with opioid use disorders and chronic pain have greater attitudinal barriers to analgesic use than those without opioid use disorders. Patients with substance use disorders have lower attitudinal barriers to reporting pain to physicians. Given the substantial functional, social, and psychological consequences of undertreated pain, there is an imperative for physicians to work with patients who have comorbid pain and substance use disorders to address their attitudinal barriers to pain medications. This study highlights a modifiable barrier to effectively treating chronic pain in patients with SUD. Further clinical care and research should focus on addressing attitudinal barriers so that patients may have maximum pain relief without compromising recovery from addiction.


In 2009, 665 patients underwent total knee replacements (TKRs) at the Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH), representing nearly 1% of the national total. Pain control following the operation can be poor, and this can cause poor mobilization and potential long-term adverse events. Although high levels of pain are not associated with patient dissatisfaction, brief periods of pain may lead to neuronal remodeling and sensitization. Patient controlled oral analgesia (PCOA) may improve pain relief; however, the evidence to date has been inconclusive. Patient directed self management of pain (PaDSMaP) is a single center randomized controlled trial, which aims to establish if patient self-medication improves, or is equivalent to, treatment as usual and to create an educational package to allow implementation elsewhere.Patients eligible for a TKR will be recruited and randomized in the outpatient clinic. All patients will undergo their operations according to normal clinical practice but will be randomized into two groups. Once oral medication has commenced, one group will have pain relief administered by nursing staff in the usual way , whilst the second group will self manage their pain medication . Those recruited for self-medication will undergo a training program to teach the use of oral analgesics according to the World Health Organization (WHO) pain cascade and how to complete the study documentation. The primary endpoint of the trial is the visual analogue scale (VAS) pain score at 3 days or discharge, whichever is sooner. The follow-up time is 6 weeks with a planned trial period of 3 years. The secondary objectives are satisfaction with the management of patient pain post-operatively whilst an inpatient after primary TKR; overall pain levels and pain on mobilization; satisfaction with pain management information provided; global outcomes, such as quality of life (QOL) and activities of daily living (ADLs); time to mobilization and whether time to mobilization is associated with frequency of adverse events, improvements in QOL, ADLs and pain at 6 weeks after the operation; incidence of adverse events; quantity and type of pain medications used whilst an inpatient; the acceptability of PaDSMaP and/or TAU protocols for patients and the healthcare professionals involved in their care; to investigate the health-related costs associated with a PaDSMaP system; and to estimate the cost-effectiveness of PaDSMaP compared to TAU.Current Controlled Trials ISRCTN: 10868989 In the four years to 2007 to 2008, the number of primary total knee replacements (TKRs) increased by 163% to 73,455 in England and Wales. These figures are expected to continue increasing owing to the ageing demographic of the UK population[After a TKR operation, patients experience substantial pain but there is debate on the best way to manage it,4. PoorlThe World Health Organization (WHO) introduced the concept of the analgesic ladder. Under t• Step one: Non-opioid analgesics. For example aspirin, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs). If anticipation of pain can be abolished, it may not be necessary to step up to opioids. Give non-opioid regularly and use adjuvants if necessary.• Step two: Mild opioids. For example codeine, dihydrocodeine; with or without non-opioid.• Step three: Strong opioids. For example morphine (Oramorph); with or without non-opioid.The WHO guidelines for pain management state that the evidence now suggests that pain can be best managed when drugs are taken ‘by the clock’. HoweverIt is further proposed that a patient’s level of pain and satisfaction with care may be influenced by who delivers pain control medications, whether it is patient directed  or under nurse control . The ‘by the clock’ analgesia regimen may be more easily followed in patient controlled oral analgesic (PCOA) protocols. It is proposed that PCOA may also allow patients to vary their analgesia more easily according to pain and activity levels, for example in advance of mobilization. In addition, since pain is a combination of tissue damage and emotional state, it is hypothesized that being in control via self-medication may reduce the emotional component of pain. It is known that psychological resilience and preparedness make it easier to control pain,12.However, there is limited and divergent evidence for the efficacy and acceptability of PCOA. Two studies by Striebel,14 claimPatient understanding about analgesia is critical for adherence, since it has been found that patients take fewer analgesics than prescribed post-operatively, even if they report a high level of pain,17. PatiPost-operative pain management at the NNUH will be given by an initial ‘by the clock’ approach to medicating, to prevent pain before it resurfaces. Ongoing monitoring of the pain will take place to ensure there is no breakthrough pain and then either additional ‘as needed’ doses or downward titrations of the initial dosage, depending on pain levels, can be administered. This type of proposed schedule is consistent with the flexibility recommendations of the Agency for Healthcare Research and Quality (AHRQ).Therefore, the information provided to participants should cover issues of importance to them, includiThis study’s PaDSMaP intervention addresses the key aim of the Darzi Report: ‘An NHSTo investigate if PaDSMaP reduces pain at 3 days or on discharge, whichever is sooner, after primary TKR operation compared to TAU.To investigate whether the PaDSMaP and TAU groups differ in terms of:• Patient satisfaction with the management of their pain post-operatively whilst an inpatient after primary TKR.• Overall pain levels and pain on mobilization.• Satisfaction with pain control.• Satisfaction with pain management information provided.• More global outcomes, such as quality of life (QOL) and activities of daily living (ADLs).• Time to mobilization, and whether time to mobilization is associated with frequency of adverse events, and improvements in ADLs, QOL and pain at 6 weeks after the operation.• Incidence of adverse events.• Quantity and type of pain medications used whilst inpatients.Additional secondary objectives include: to investigate the acceptability of the PaDSMaP and TAU protocols for patients and the healthcare professionals involved in their care; to investigate the health-related costs associated with a PaDSMaP system; and to estimate the cost-effectiveness of PaDSMaP compared to TAU.This study has been approved by the Cambridgeshire 1 Research Ethics Committee approval Ref: 10/H0304/52. The study will be conducted in full conformity with the current revision of the Declaration of Helsinki , and in full conformity with relevant regulations and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guidelines for Good Clinical Practice, CPMP/ICH/135/95, July 1996.A research nurse from the study team will meet with the patient at the pre-operative assessment clinic (2 to 3 weeks prior to operation) and make a final check on trial eligibility. Written and verbal versions of the participant information leaflet will then be presented detailing the exact nature of the study. In particular, the research nurse will explain the randomized allocation element of the trial. It will be made clear that the patient is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal. The patient will be allowed as much time as they wish to consider the information and ask questions. If required, the research nurse will facilitate opportunities to question other members of the research team, the patient’s general practitioner (GP) or other independent parties, to decide whether the patient can participate in the study. This may mean that the research nurse has to arrange a subsequent home visit at a later date after prior agreement and arrangement with the patient.Written informed consent will be obtained by means of a participant dated signature and dated signature of the research nurse. These signatures will be obtained on the latest approved version of the informed consent form, before any study-specific procedures are performed. A copy of the signed informed consent will be given to the participant and a copy will be retained by the Trial Office at the University of East Anglia (UEA). The original signed form will be sent to the participant’s GP.For those participants recruited into the qualitative interview aspect of the trial, a further information sheet will be given and a consent form will subsequently be completed and signed. As above, a copy will be given to the participant and a second copy will be retained by the Trial Office at the UEA.All data will be handled in accordance with the Data Protection Act 1998, which requires data to be anonymized as soon as it is practical to do so. Each participant will have a case record file containing copies of consent forms, completed measures and demographic information. Case record files will be kept in a locked cabinet within a locked room at NNUH. Only the chief investigator (RG), the project lead (KD) and the research nurse will have access to these. Both RG and KD have extensive experience of clinical trials, and RG and KD are trained in the ICH and WHO Good Clinical Practice Standards for Clinical Trials.The trial staff will ensure that the participants’ anonymity is maintained. The participants will be identified only by initials and a participant ID number on case report forms and electronic databases. All documents will be stored securely and will only be accessible by trial staff and authorized personnel.This study uses a prospective, randomized, parallel-group design to compare PaDSMaP to TAU for patients undergoing a primary unilateral TKR at a teaching hospital, the NNUH. The analysis of clinical outcomes will be blinded. It will not be possible to blind the health economic data analysis.One hundred and forty-four patients who have just undergone TKR will be randomly assigned to the PaDSMaP or TAU groups pre-operatively. This study will investigate whether PaDSMaP improves levels of pain at 3 days or discharge, whichever is sooner, after a TKR operation, compared to TAU. It will also compare the two groups up to 6 weeks after the operation for pain levels, satisfaction with the control of pain, return to walking and normal activities, as well as any further problems. We will also interview a sample of 12 patients (six patients from each group) and 12 healthcare professionals involved in their care, to explore their experiences of the PaDSMaP and TAU protocols. Finally, we will measure the costs of PaDSMaP compared to those of TAU.In addition, the patients entered into this study will form a group that will be followed up in standard nurse-led remote follow-up clinics for up to 5 years, to determine the impact of pre-operative characteristics  and levels of post-operative pain control on the long-term success or failure of TKRs, as defined by the development of chronic pain, return to normal activities and impact on QOL.The primary outcome for PaDSMaP is pain levels at discharge or after 3 days, whichever is sooner, after primary unilateral TKR in patients, as measured by a 10 cm continuous visual analogue scale (VAS).Secondary outcome measures for the patients comprise:• Pain levels (pre-operative assessment clinic baseline (2 to 3 weeks prior to operation), Days 1 to 3 and 6 weeks post-operatively).• Pain after mobilization (3 times a day for Days 1 to 3 post-operatively).• Satisfaction with pain levels (Days 1 to 3 and 6 weeks post-operatively).• Satisfaction with Information about Medicines Scale (SIMS) (Day 3 and 6 weeks post-operatively).EuroQoL EQ-5D questionnaire (EQ-5D) .• Oxford Knee Score (OKS) .Time to mobilization (inpatient notes).• Adverse events (Days 1 to 3 and 6 weeks post-operatively).• Medication usage .• A health resource use questionnaire .• Qualitative evaluation of patients’ and health professionals’ experiences .See TableThe study is aimed at patients who are about to undergo a primary unilateral TKR. We will recruit patients referred to the orthopaedic clinics for TKR at the NNUH.• All adult patients aged over 18 years undergoing a primary TKR operation.• Meet the NNUH self management of pain criteria.• Are expected to require standard step 1 to 3 oral analgesics post-operatively• Post-operatively, patients must be awake and breathing independently, able to answer questions and follow commands to continue in the protocol.• Are English speaking and literate. • Patients may have received regional blocks or epidural analgesia and will start PaDSMaP or TAU as soon as they begin oral analgesia.• Expected to require intensive care.Known, or suspected to be, opioid tolerant or dependent.• Regular users of any modified release opiate preparation during the 2 weeks prior to TKR.• Recent history of drug or alcohol abuse.• Lack competence to consent by reason of dementia or any other reason.• Any patient who does not self-administer at home.These inclusion and exclusion criteria are in line with the NNUH’s drug self-administration policy.Patients eligible for a primary TKR will be given an information sheet and consent form at the outpatient clinic where the patient is added to the TKR waiting list (approximately 6 weeks prior to operation). In addition, any potential participant who is missed from this clinic, but is placed on the TKR waiting list, will also be sent an information sheet and consent form by post.A phone call from the research nurse will be made to eligible patients approximately 1 week prior to the pre-operative assessment clinic. The purpose of this phone call is to determine if the patient is interested in participating in the PaDSMaP study. The phone call will not be regarded as confirmation of patient consent to participate in the study; consent will be taken during the clinical appointment. The purpose of the call is to ensure that the research nurse is available to appropriately conduct consent and carry out baseline measures and education on the PaDSMaP protocol, as appropriate.Six patients from each group will be purposively sampled to participate in interviews to assess the acceptability of the PaDSMaP and TAU protocols. The patients will be purposively selected according to pre- and post-operative characteristics that may have had an impact on their experience of the pain control protocols .The selected patients will be sent separate information sheets and consent forms for this section of the research protocol at least 1 week prior to their 6 week follow-up outpatient appointment by the research nurse. At this appointment the research nurse will explain the interview process, the arrangements for the interview and ensure the patient understands the patient information leaflet for interview detailing the exact nature of the interviews. Again it will be made clear that the patient is free to withdraw from the study at any time for any reason without prejudice to future care, and with no obligation to give the reason for withdrawal. The patient will be allowed as much time as they wish to consider the information and ask questions. If consent is given, the research nurse will organize an appointment for the interview. The interview can take place at the patient’s home or in a private room at the hospital, whichever is the patient’s preference. Should the patient withdraw from the interview at the time it is undertaken, the data will not be used. Once an interview transcript has been received by the patient for checking they will then have a 2 week period to withdraw from this section of the study, or it will be presumed that that the transcript can be used.Twelve healthcare professionals, representative of the team that looks after patients after a TKR, will also be purposively selected to participate in interviews to investigate their views on the PaDSMaP and TAU protocols. These interviews will be held after the majority of patients we aim to recruit have passed through the PaDSMaP protocol. The healthcare professionals will be sent information sheets and consent forms. The research nurse will then contact them to ask if they would be willing to participate in the interview.If they indicate they are willing, an appointment will be made to meet with the research nurse during working hours in a private room at the hospital. The research nurse will explain the interview process, the arrangements for the interview and ensure the healthcare professional understands the healthcare professional information leaflet detailing the exact nature of the interviews. It will be made clear that the healthcare professional is free to withdraw from the interview at any time for any reason and with no obligation to give the reason for withdrawal. If written consent is provided, the interview will proceed. Withdrawal from the study will be on the same basis as the patient interviews.When consent has been obtained the research nurse will collect baseline data from patients. The research nurse will be trained in administering questionnaires in a standardized way. The majority of the outcomes will be self-completed by the patients. The research nurse will regularly visit the orthopaedic wards to encourage completion of the questionnaires by patients in both arms of the trial. The following information will be obtained.Pain levels will be measured using a 10 cm continuous VAS bounded by the phrases ‘no pain’ and ‘worst possible pain’. PatientsPain VAS for the previous 4 hours will also be measured at a variety of time points , the Data Monitoring and Ethics Committee (DMEC) chair (Dr Sanders) and, where appropriate, with the governance lead for the Trust. Adverse events will be recorded from the point patients are entered into the study (at randomization in the pre-operative assessment clinic) to the point at which they leave the study (the 6 week follow-up clinic).All medications that are used by the participants in the study will be documented. At baseline, all medications and dosages currently taken by the patient will be recorded, particularly those used for pain relief. During the hospital inpatient stay participants in the PaDSMaP group will be asked to note the type of pain relief medication they took, the dose and the exact time at which they took it on the inpatient prescription chart. Digital illuminated clocks will be provided in the drug boxes for the PaDSMaP group. Nurses looking after patients in the TAU group will be asked to note the exact time of delivery of the analgesic drugs on the inpatient prescription chart. At the 6 week follow-up, patients will be asked to report their current medication usage.In line with guidance from the National Institute for Health and Clinical Excellence (NICE), costs wThe following measures regarding the character of the recruited population will also be collected at baseline. These will inform assessments of the generalizability of the study, the success of the randomization process and may help to identify some potential confounding factors:• Age (years).• Gender.• Ethnicity.• Whether there will be someone to assist the patient on discharge (for example spouse or carer).• Whether the residence the patient will be discharged to has stairs.• Level of education.• Socioeconomic status (estimated using participants’ postcodes).• Body mass index .• Duration of knee pain.• Current level of knee pain (VAS).• Previous experience of orthopaedic surgery (what and when).• Expectation of level of pain post-operatively at Days 1 to 3 and week 6 (VAS).• Medication profile .• Comorbidities.• Other musculoskeletal problems.• Surgical procedures undertaken in TKR .• Hospital Anxiety and Depression Scale (HADS).• Beliefs about Medications Questionnaire (BMQ).Surgical procedure questions will be gathered as part of standard practice for the National Joint Registry (NJR). They wiThe HADS identifiThis BMQ will be 1. General harm (G-H) that is, the intrinsically harmful properties of medications .2. General overuse (G-O) of medications by healthcare professionals .3. General sensitivity (G-S) to adverse events from medications .4. General benefit (G-B) that is, the intrinsically beneficial properties of medications .The research nurse will check patient eligibility and consent against a checklist. Authorized research nurses will each be allocated a six-digit personal identification number (PIN) for use when randomizing patients. The research nurse will telephone the independent randomization service at the Clinical Research and Trials Unit (CRTU) at the UEA. The system will request the PIN and will only proceed if a valid PIN is entered via the telephone keypad.On entry of a valid PIN, the system will generate a unique study code and randomly allocate the patient to either the PaDSMaP or TAU arm of the trial. The study code and allocation will be reported back to the caller verbally and will also be sent in a confirming email to: a) the caller, b) other nominated trial staff and c) the trial database manager. The study code and allocation will be stored in the trial database on the secure CRTU server at UEA.A computer generated randomization list will allocate patients in a 1:1 ratio to PaDSMaP or TAU groups. Randomization is unstratified. To ensure a reasonably even distribution of patients in the two arms throughout the course of the trial, patients will be allocated in randomly distributed blocks of four and six.At the pre-operative assessment clinic, patients that have expressed an interest in participating in the PaDSMaP study will go the CRTU after their clinic appointment. At CRTU they will be consented and randomized. The baseline assessments will be conducted and patients instructed on how to complete the trial inpatient outcome measures. It is anticipated that this will take about 1.5 hours in total.Patients in the TAU group will receive the standard general information sheet and DVD outlining the TKR operation and recommendations for both pre- and post-operative exercises.The study is a pragmatic trial and as such normal variations in pre- or post-operative anaesthetic are part of what will be examined. The patient’s initial post-operative analgesic care will be under the direction of the anaesthetists and this normally lasts for 12 to 24 hours post-operatively. Oral analgesia will be initiated prior to pain resurfacing after, for example, the epidural has worn off. Patients’ oral post-operative analgesia on the wards will be dispensed as usual by the nursing team to the TAU group.We expect that the majority of patients recruited to this study will receive the Modified Caledonian Technique (MCT) Norwich Enhanced Recovery Program (NERP). This program aims to enhance the recovery of patients having primary knee replacements by a multimodal program, which facilitates early mobility and discharge. The NERP focuses on the provision of safe and effective analgesia with minimal side-effects, which then enable early mobility. Of note, gabapentin is included because it is an opioid-sparing medication and reduces opioid-related side-effects.Centers in the UK and abroad adopting the enhanced recovery program have reduced patients’ length of stay significantly. It is likely that the exact details of the NERP will develop over the course of the trial. It should also be noted that individual patients will always be offered the most suitable protocol for their particular circumstances, so some patients will not follow the NERP protocol. Again this does not prove an obstacle, since the study is a pragmatic trial and variations in care are part of what is to be examined.Enhanced recovery programs are multimodal and focus on the following elements:1. Educating GPs and community support services.2. Patient education and support.3. Pre-operative physiotherapy, and occupational therapy assessment and education.4. Pre-operative anaesthetic and surgical assessment.5. Utilizing surgical and anaesthetic techniques, which facilitate early mobility.6. Excellent post-operative analgesia allowing early patient mobilization.7. Intensive post-operative physiotherapy.8. Early discharge with appropriate back-up and follow-up.• Gabapentin 300 mg orally (2 hours before operation or can be given the night before).• Single shot spinal 2.5 to 3.0 ml bupivacaine plus total continuous infusion (TCI) of propofol for sedation .• Ondansetron 4 mg intravenous (IV).• Paracetamol 1 g IV.• Dexamethasone 8 mg IV.• Diclofenac 75 mg IV, if tolerated.• Tranexamic acid .• No opiates.• No urinary catheter.• Limit fluids to approximately 1 litre intra-operatively, if possible.• Surgeon infiltrates joint space with 150 to 200 ml of 0.2% ropivacaine .• Surgeon places clearly labeled catheter into the joint space (periarticular catheter).• Infusion set up with McKinley pump of ropivacaine 0.2%, 200 ml.• Give 20 ml bolus and set pump at 5 ml per hour.• Gabapentin 300 mg twice a day for 5 days.• Paracetamol 1 g orally four times a day.• Ibuprofen 400 mg three times a day, if patient is able to tolerate.• Oxycodone (OxyContin) 10 to 20 mg twice a day for 3 to 5 days.• Morphine (Oramorph) 5 to 20 mg as needed up to every 2 hours for breakthrough pain.• Ondansetron 4 mg twice a day IV as needed.• Providing that the patient’s systolic blood pressure is within 10% of its pre-operative reading, the patient will be mobilized 4 hours after surgery (Day 0). If a patient feels dizzy on attempting to mobilize, or their blood pressure drops to below 80 mmHg systolic, oral ephedrine 30 mg  is given and mobilization is attempted again after 30 minutes.The patient will be mobilized three times on the first post-operative day. Once the patient is stable on crutches without support, they will be encouraged to mobilize independently. The patient will receive physiotherapy three times a day until discharge.If appropriate, the patient will be discharged on Day 3 to 4. The discharge criteria will be:• Able to mobilize independently.• Pain is well controlled on oral analgesics.Patients will be discharged with 14 days of oral analgesics and informed that they must visit their GP for a further prescription. The patient will be telephoned at home on Day 7 post-discharge.Effective treatment of pain requires individually tailored care pathways and treatment strategies. The PaDSMaP package will be developed by members of the research team in conjunction with relevant clinical and lay experts. This will result in a comprehensive, structured, evidence-based training manual with associated information in a range of appropriate formats, capable of being tailored according to individual needs, and designed for delivery by a trained research nurse and the post-operative ward team. Patients in the TAU group will receive the PaDSMaP patient information sheet, but all other aspects of their care before, during, and after their TKR operation will be TAU.Patients will get a short break after the consent process and baseline assessments are completed before they receive training in the PaDSMaP protocol. Patients will receive an information sheet and a DVD, which in addition to the standard information on the operation and pre- and post-operative exercises, will include information on the PaDSMaP self-medication protocol. The research nurse will then take 20 minutes to explain how to self-monitor their pain and medicate it appropriately. Patients will receive protocols outlining how to maximize analgesia, how they can adjust their analgesic levels, and receive information prior to the operation about appropriate pain control and why pain control is important .The PaDSMaP information sheet covers the issues identified by Kastanias as impor• Expectations of the pain experience itself.• What the analgesic plan is and what to do if it does not work.• Other ways of dealing with pain in addition to medicine ,18.• Side-effects of analgesics, both what to expect and how to manage side-effects.Patients in the PaDSMaP group will be in charge of their post-operative oral analgesia. The patients will have a lockable drugs cabinet at their bedside that is easily accessible to them. The drugs cabinet will contain 14 days’ supply of all of the drugs a patient is prescribed for self-medication . The drug boxes will be resupplied on a daily basis to ensure 14 days’ supply is available. The usual prescribed regimen will be as for TAU post-operative oral analgesia:• Gabapentin 300 mg twice a day for 5 days.• Paracetamol 1 g orally four times a day.• Ibuprofen 400 mg three times a day, if patient is able to tolerate.• Oxycodone (OxyContin) 10 to 20 mg twice a day for 3 to 5 days.• Morphine (Oramorph) 5 to 20 mg as needed up to every 2 hours for breakthrough pain.Some drugs, such as oxycodone (OxyContin), are not approved for self-medication protocols at NNUH owing to their being scheduled drugs. In the event that a scheduled drug is prescribed, it will be delivered by the ward nurse as part of their usual drug rounds. The scheduled drug(s) will be the only drug(s) that patients receive from the ward nurses; patients will self-medicate with all other drugs.Patients will be discharged with 14 days’ supply of drugs. This will not usually include morphine (Oramorph) or oxycodone (OxyContin).The WHO guidelines for pain management state that the evidence now suggests that pain can be best managed when drugs are taken ‘by the clock’ and patients in the PaDSMaP arm will be encouraged to do so. However, patients will also be encouraged to follow a pre-specified protocol to treat breakthrough pain, that is a combination of ‘by the clock’ and ‘as needed’ protocols. Policy documents repeatedly state that adequate monitoring of pain levels is a key principle of pain management and so PaDSMaP patients will be encouraged to monitor their pain hourly. Thus, our plan is an initial ‘by the clock’ approach to medicating (to prevent pain before it resurfaces), ongoing monitoring of the pain to ensure there is no breakthrough pain, and then either additional ‘as needed’ doses or downward titrations of the initial dosage, depending on pain levels. This type of proposed schedule is consistent with the flexibility recommendations of the AHRQ.The ward nurses and pharmacists will also receive appropriate training to support patients who are self managing their pain.Baseline measures of efficacy will be repeated at 6 weeks post-operatively. This time-frame reflects the usual outpatient follow-up clinic time point. The research nurse will ensure completion of all self-assessment scales at this outpatient clinic.Primary and secondary outcomes will be compared between intervention and control groups using t-tests, non-parametric tests or chi-squared and Fisher’s tests, as appropriate. Where differences are observed between outcome measures, demographics and patient characteristics at baseline, adjusted effect sizes will be estimated using linear models.To assess external generalizability, demographic and clinical characteristics of participants’ responses at the baseline phase of the study will be compared with participants who are subsequently randomized, and participants who are screened but not randomized. The specific criteria by which participants are excluded from randomization will be tabulated.t-test. Dahlen[Seventy-two patients in each arm are sufficient to detect a between-group difference of 0.5 standard deviations in the VAS pain intensity with 80% power using an independent samples . Dahlen reportedTwelve patients from each arm and 12 healthcare professionals will be interviewed to investigate acceptability. The patients will be purposively selected according to pre- and post-operative characteristics that may have an impact on their experience of the pain control protocols . Team members will be selected to represent the spectrum of healthcare professionals that come into contact with patients after a TKR .In 2009, 665 patients had TKR operations at the NNUH. The trial requires recruitment of 144 patients over 24 months, which represents approximately 11% of this population, to meet the requirements of the power calculation. In order to determine if this rate of recruitment was feasible, a mock recruitment was conducted, asking patients that would be eligible for the PaDSMaP trial whether they would consider participation as part of their pre-operative clinic interviews.Allowing for patients being excluded, the planned recruitment rate is six patients per month over a 24 month period. This target will be reviewed after 6 months.The efficacy of the intervention on the primary outcome (pain VAS) will be assessed by comparing outcomes at discharge or 3 days post-operatively, whichever is sooner, between the two groups. Adjusted estimates will be obtained by identifying baseline variables, which differ between the groups and which are related to the outcome, and incorporating these into a regression analysis.Both intention to treat (ITT) and per-protocol (PP) analyses will be performed. The ITT analysis set will comprise all patients who have been randomized to each intervention, irrespective of their compliance with the planned course of treatment. This is the primary analysis and will be used for evaluation of all endpoints. The PP set will include patients that have not deviated from the protocol in such a manner that the assessment of efficacy endpoints may be biased. Appropriate adjustments will be made in the statistical analyses for potential confounding factors. These include age, gender, socioeconomic status, level of knee pain pre-operatively, levels of anxiety and depression.The aim of the economic evaluation is to assess whether PaDSMaP represents a cost-effective use of scarce NHS resources when compared to TAU.In line with NICE guidance, costs will be calculated from the perspective of the NHS and personal social services, and encompass those costs that are potentially related to the intervention in question. Thus, for all patients we will monitor the levels of resource use associated with the inpatient stay (including medication use), any re-admission to hospital and other healthcare contacts .Patient resource use will be obtained from responses to a health resource use questionnaire at baseline and 6 weeks post-randomization. Appropriate unit costs,36 will The measure of effectiveness employed in the economic analysis will be measured by the EQ-5D. This isThe subjective nature of the self-report instruments used for evaluation of the intervention is accepted and every effort will be made to minimize potential bias owing to this dynamic. In particular, patients may over- or under-report their health status depending on the trial arm to which they have been assigned.We will estimate both the mean overall cost and mean overall effect associated with PaDSMaP, compared to TAU. If one of these options is shown to be less costly and more effective than the other, then this would suggest that it ‘dominates’ the other and represents a cost-effective use of scarce resources. Alternatively, the incremental cost-effectiveness ratio associated with PaDSMaP will be estimated and assessed in relation to a range of cost-effectiveness thresholds . The asAll patients will be asked to rate their satisfaction with the information provided to them. A phenomenological assessment of the two protocols will be conducted using in depth semi-structured interviews undertaken with a purposively selected subsample of patients (n = 12). In addition, healthcare professionals involved in delivering the intervention will be interviewed to explore their perceptions of the process of using PaDSMaP (n = 12). The aim of these interviews will be to:• Obtain insights into patients’ and health professionals’ experiences of using the pain relief protocols .• Consider which elements of the PaDSMaP and/or TAU were perceived as being most and least helpful.• Explore the participants’ perceptions of the effect that they think PaDSMaP and/or TAU protocols has had on them.• Uncover any potential barriers and roadblocks to using the PaDSMaP and/or TAU protocols.• Explore how the PaDSMaP and/or TAU protocols could be refined and enhanced.An interview schedule will be used for consistency and to ensure coverage of all areas above deemed important. Participants will be prepared for an interview of approximately 30 minutes. Following consent, the first interviews will be conducted by the research nurse and take place at patients’ homes and other appropriate venues . All interviews will be audio-recorded, transcribed verbatim and sent to the participants for corroboration. Interviewees will be able to adjust the transcript so that it reflects their views appropriately. Confirmed transcripts from all of the interviews will then be analyzed using the principles of framework analysis to organize the data and identify emerging categories and key themes or concepts using NVivo v.8. If the We will start selecting patients for interview after recruiting 25% of the target number of patients for the study, that is after the first 36 patients. All patients interviewed will have been randomized to the PaDSMaP self-medicating arm of the study. The logic behind the criteria is:• Gender can influence the relative efficacy of analgesics, may represent differing attitudes to being in pain and to taking medications to control pain.• Pain expectation may predict post-operative pain levels.• Length of stay as a representation of a combined measure of pain levels, activity and mobility, and ability to cope relatively independently after the operation.• Age may influence the activities that one returns to, for example work or retirement. This may influence decisions to have the operation in the first place, expectations of functionality afterwards and activities likely to be undertaken.Healthcare professionals will be recruited following the patient interviews and will include ward sisters, ward nurses, physiotherapists, pharmacists and members of the pain team. We aim to recruit 12 staff. They will all have treated at least one patient in the PaDSMaP arm and one in the TAU arm. Owing to the difficulty of retaining anonymity of comments in such a small pool of professionals we will refer to staff as either being nurses or allied health professionals (AHPs) in publications.The project will take place over 3 years (36 months) including preparation and write-up/dissemination time.The Research Ethics and Research Governance approvals process will start 6 months before the start of the study to allow all approvals to be secured before the study starts.Research set-up (minus 6 months to start) will include preparing and submitting ethics and research and development (R&D) applications, refining and finalizing research protocols (minus 6 months to start), recruiting and training the research nurse in the protocol and consent procedures, and setting up research sites (Months 1 to 4).One hundred and forty-four patients will be identified for the study by the surgical consultants (approximately 6 weeks prior to surgery), and given information sheets and consent forms. They will then be recruited to the study, consented, randomized and baseline information taken by the research nurse at the pre-operative assessment clinic in one 90 minute session per patient (approximately 2 to 3 weeks prior to surgery). Patients allocated to the PaDSMaP arm will also be educated in self-administration of analgesia at this clinic (20 minutes). After surgery, the patients will be given appropriate intervention and assessed daily for 3 days post-operatively or until discharged home, whichever is sooner. The patients will be followed up at the post-operative clinic (6 weeks post-surgery) and the final data will be collected in 30 minute interviews per patient by the research nurse (patients will be recruited in Months 1 to 24).Thirty minute one-to-one interviews will be conducted by the nurse researcher with a subsample of 12 patients from the PaDSMaP arm and 12 healthcare professionals. Patient interviews will be conducted in their homes after the 6 week post-operative clinic has been conducted (Months 3 to 24) and healthcare professional interviews will occur after the majority of participants have passed through the protocols (Months 20 to 26) in a private room at the hospital.Reports and dissemination will include publication of the trial protocol (Month 0), a newsletter to trial participants summarizing the trial’s results, attendance at conferences and publication in relevant peer-reviewed medical journals (Months 34 to 36). The trial will be reported in line with Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines.Patients in this cohort will continue to be followed up, as is standard practice, and their pain (VAS), ADL (OKS) and QOL (EQ-5D) will be audited up to 5 years post-operatively. Nurse-originated clinical research leading to a randomized clinical trial is unusual. PaDSMaP is such a trial and although involves orthopaedic patients, it is very much clinical nurse research in emphasis. Whilst the primary outcome for PaDSMaP is pain levels at discharge or after 3 days, whichever is sooner, the secondary outcomes and associated information gained from the study will have important implications for patient care. PaDSMaP is more than just a study looking at the levels of pain relief and comparing self-medicating patients with nurse drug rounds; it is also about understanding the views of all the stakeholders on the acceptability of self-medication. The study aims to show whether patients’ management of pain improves QOL and time to mobilize.The idea that patients should self-medicate in hospitals raises a number of concerns by staff, especially with ward nurses and pharmacists. The main concerns are patients overdosing on opiate analgesics, as well as their ability to look after themselves following a major operation. In certain specialties where self-medication is already in place, overdosage is not a reported problem. Following an operation, self-medication is delayed until the patient is alert and well enough to do so. The new enhanced recovery programs for surgery include anaesthetic techniques designed to minimize delirium, as well as nausea and vomiting to allow early (day of operation) mobilization. In addition, patients are expected to self-medicate at home, and the ward environment is an excellent place to check on the correct usage and understanding of the medications patients take home.Regardless of the qualitative outcomes, self-medication may not be acceptable to an NHS with reduced resources, unless it proves itself to be cost-effective, for example in terms of a reduced need for medication, or has a positive effect on length of stay, time to mobilization and adverse effects. The range of measures used in this study aim to give a rounded view on the efficacy of self-administration from both economic, patient and staff perspectives. The qualitative interviews aim to uncover the blocks to implementing this change and will provide valuable insight into the appropriate patient groups where self-medication can be a successful intervention.Developing the PaDSMaP study has already resulted in the creation of standard operating procedures (SOPs) in self-medicating for the pharmacy and wards, plus instructional booklets on self management of pain and the various drugs involved. This package can be used in other settings where self-administration may be proposed and provides a template for similar packages for other medical conditions.The trial does have a problem with generalizability. It is a single hospital, single ward study in a mainly rural area with an overwhelmingly English-speaking population. It is also focused on patients undergoing TKR, which was chosen because of the longer length of stay and higher pain levels than total hip replacement or unicompartmental knee replacement. However, it is the nature of the NHS that developments occur all the time. The NERP was introduced soon after the inception of this study and this has shortened the inpatient stay. It is also used for the majority of patients and again this affects the generalizability. NERP standardizes care and so may reduce the advantages (or otherwise) of self-medication. It does, however, reduce the variation in pain management, which was typical only 2 or 3 years ago.The single center randomized controlled PaDSMaP trial is designed to look at the efficacy and safety patient self-medicating analgesia following TKR. The trial includes a qualitative element and aims to create a package that can be used to roll out the process in other hospitals.Recruitment started in July 2011. The study is recruiting to time and target, with recruitment closure anticipated for May 2013.ADLs: activities of daily living; AHRQ: Agency for Healthcare Research and Quality; AHPs: allied health professionals; BMI: body mass index; BMQ: Beliefs about Medications Questionnaire; CONSORT: Consolidated Standards of Reporting Trials; CRTU: Clinical Research and Trials Unit; DMEC: Data Monitoring and Ethics Committee; EQ-5D: EuroQoL EQ-5D questionnaire; GP: general practitioner; HADS: Hospital Anxiety and Depression Scale; ICH: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; ITT: intention to treat; IV: intravenous; MCT: Modified Caledonian Technique; NERP: Norwich Enhanced Recovery Program; NHS: National Health Service; NICE: National Institute for Health and Clinical Excellence; NIHR: National Institute for Health Research; NJR: National Joint Registry; NNUH: Norfolk and Norwich University Hospitals NHS Foundation Trust; NSAIDs: non-steroidal anti-inflammatory drugs; OKS: Oxford Knee Score; PaDSMaP: patient directed self management of pain; PCA: patient controlled analgesia; PCOA: patient controlled oral analgesia; PIN: personal identification number; PP: per-protocol; PROMs: patient reported outcome measures; QALY: quality-adjusted life year; QOL: quality of life; R&D: research and development; RfPB: Research for Patient Benefit; SIMS: Satisfaction with Information about Medicines Scale; SOPs: standard operating procedures; VAS: visual analogue scale; TAU: treatment as usual; TCI: total continuous infusion; TKR: total knee replacement; UEA: University of East Anglia; WHO: World Health Organization.The authors declare that they have no conflicts of interest in this protocol and study.All authors were involved in the development of the protocol. CD conceived the research idea. KD was the coordinator and reviewer. LS provided the statistical advice. GB provided the health economics advice. PB provided the qualitative expertise. RG provided nursing, protocol development and trial management expertise. SD provided the orthopaedic perspective and expertise in conducting clinical trials in a secondary care setting. All authors read and approved the final manuscript.