Hemorrhoidal disease (HD) is the most common proctological disease in the Western countries. However, its real prevalence is underestimated due to the frequent self-medication.The aim of this consensus statement is to provide evidence-based data to allow an individualized and appropriate management and treatment of HD. The strategy used to search for evidence was based on application of electronic sources such as MEDLINE, PubMed, Cochrane Review Library, CINAHL, and EMBASE.These guidelines are inclusive and not prescriptive.The recommendations were defined and graded based on the current levels of evidence and in accordance with the criteria adopted by American College of Chest Physicians. The recommendations were graded A, B, and C. These guidelines were based on the last Italian Society of Colorectal Surgery  clinical practice guidelines for the evaluation and management of hemorrhoidal disease (HD) published in 2015 , the presence of primary and secondary outcomes, study methodology , English language, and the evaluation of papers published only in indexed journals with impact factor. Prospective randomized-controlled trials and meta-analyses were given preference in developing these guidelines.Directed searches of the embedded references from the candidate articles were also performed.The recommendations were defined and graded based on the current levels of evidence and in accordance with the criteria adopted by the American College of Chest Physicians Table  2].Tabl.Tabl2].TThree evidence levels were defined. The recommendations were graded A, B, and C.Members of the SICCR were invited to contribute to the production of these guidelines and final recommendations were reviewed by the entire Clinical Practice Guidelines Committee. SICCR Clinical Practice Guidelines are updated every 4 years.The target users of guidelines are coloproctological surgeons, gastroenterologists, general practitioners, nurses, and other medical specialists who treat anoperineal diseases.The guidelines may be used to inform clinical decisions and standards of care. The guidelines are also intended to inform patients about the possible alternatives for the management of their condition.HD is the most common proctological disease with an estimated prevalence rate of 4.4%, with a peak in individuals between 45 and 65 years of age . FurtherSymptoms of HD may overlap with those of other anorectal conditions such as skin tags, abscesses, fissures, polyps, inflammatory bowel disease (IBD), and anorectal neoplasms. The most common presentation of HD is painless rectal bleeding that occurs during or immediately after defecation. Usually, it is mild–moderate bright red bleeding which the patient observes on the feces or staining the toilet paper –7. RecurPain is rare in case of uncomplicated HD. In fact, its presence may indicate other simultaneous painful conditions . Acute edema and thrombosis of external hemorrhoids (TEH) are responsible for acute anal pain irrespective of bowel movements. Although several HD symptom scores have been proposed so far –12, to dHD classifications should meet the need to choose the most suitable therapeutic approach as well as to have shared parameters for trials and guidelines.Internal hemorrhoids are classified according to the presence and severity of prolapse as in the Goligher Classification .Unfortunately, the Goligher classification has several limitations, because it does not consider the associated symptoms and their impact on quality of life, the etiopathogenesis of the disease, and specific clinical conditions such as circumferential prolapse or single prolapsed pile.Therefore, it may not reflect the true severity of the disease and the effect of HD on the patient.(n = 45) and it is not tailored to individual patients. It takes for granted that all patients suffering with HD are affected in the same way by each individual symptom, but this may not be necessarily always the case. Furthermore, because the score for each symptom is not linear, the system is not very easy to memorise and could be difficult to use in everyday practice.To overcome these limitations, different grading systems have been developed. All the grading systems are patient self-reported assessments focusing on the presence and frequency of different symptoms. Nystrom in 2009 used a five-point-based questionnaire assessing the frequency of pain, discomfort, itching, soiling, and need for manual reduction of hemorrhoids . The sysRecently, Havard et al.  modifiedApart from the previously mentioned system, some authors have proposed other classification –22 that Diagnosis should focus on a related medical history for specific symptoms and risk factors corroborated by physical examination suggestive of HD.Diagnosis of HD should start with the collection of medical history identifying symptoms suggestive of the disease and risk factors such as constipation, a low fiber diet, sedentary lifestyle, and pregnancy. History of longstanding or uncontrolled portal hypertension should be considered for differentiate HD from anorectal varices . MoreovePhysical examination should confirm the presence of HD ruling out other anorectal diseases. It should include inspection of the perianal tissues, anorectal digital examination, and the evaluation of hemorrhoidal prolapse degree during straining. The anorectal mucosa should be examined with an anoscope. The Sims position should be preferred because less embarrassing for the patient than prone position.Patients with HD and rectal bleeding should undergo colonoscopy to rule out other colorectal diseases In Western countries, HD is one of the most frequent causes of severe acute lower gastrointestinal bleeding , 9. NeveColonoscopy should be mandatory in older patients and when there is a personal and/or a family history of colorectal neoplasms or documented advanced adenoma, IBD, history of altered bowel habits, recent significant weight loss, and a laboratory findings of iron deficiency anemia or a positive fecal immunochemical test (FIT) and guaiac-based fecal occult blood test (gFOBT) –30.Flexible sigmoidoscopy may be associated with other screening modalities, such as gFOBT or FIT, in patients that are not willing or able to undergo colonoscopy , 32.Sigmoidoscopy and colonoscopy should be integrated with anoscopy that has proven to have a higher detection rate of perianal pathology , 34.Although an increased maximum resting anal pressure is a common finding in non-prolapsing hemorrhoids , 36, manThe goal of these treatments is the control of symptoms and not the correction of pathophysiological changes.A balanced diet with adequate fiber and oral fluid intake may improve stool consistency and is one of the main purposes of lifestyle changes of the conservative treatment for HD. Constipation and in particular hard stool usually worsen symptoms related to the hemorrhoidal prolapse. A regular defecation with type 3 or 4 stool, according to the Bristol Stool Form Scale , withoutDaily oral intake of fiber, either food or supplements, shows a consistent beneficial effect for HD symptoms reducing the risk of bleeding, in case of an acute event, and as the risk of not improving symptoms in about 50% and 47% of patients, respectively. Several trials show a lack of evidence regarding a direct effect on prolapse, pain and itching .Dietary fiber intake is generally used in patients with I–II-degree HD even if it can be effective in more advanced stages. Fiber restores the normal frequency of bowel movement thanks to the increase in fecal mass, volume, and softness. Fiber should be associated with an adequate oral fluid intake, although its efficacy in treating constipation remains controversial , 42Stimulant laxatives or osmotic agents have been shown to be effective for the treatment of HD symptoms in several randomized trials with consistent results over time in reducing the risk of bleeding as well as the risk of persisting symptoms if compared with the placebo group . However.A sitz bath with warm water (not exceeding 40–42 °C for 3 min) is a traditional and frequently recommended remedy for a variety of anal disorders including HD . Unfortu.There is a lack of RCTs defining the role of sitz bath with warm water in the treatment of HD-related pain Pain relief may be related to internal sphincter relaxation with a decrease of anal resting pressure  accordinDespite its benefit, it can be difficult for the patients to perform in the hospital or at home .For this reason, another option is to sit upon a warm water bag. Furthermore, Hsu et al. demonstrated that the warm water spray method can be a safe and easily performed alternative to size bath Phlebotonics has a statistically significant effect on HD-related symptoms  if compared with a control group : the intra-procedural injection was painful in up to 90% . BleedinMucosal ulceration is one of the most frequent complications, reported in 3.6% of patients . Major c.Infrared Coagulation (IRC) should be used for the treatment of I-II and III-degree HD that fail conservative treatment It consists of the exposure of the internal hemorrhoids to infrared waves, resulting in a protein coagulation and necrosis, immediately visible as a white spot.Dimitrolopoulus et al.  reportedThe most frequent complication of IRC is a post-procedural pain which occurs in 16–100% of patients , 95. TheRecurrence of bleeding is reported in 13% of patients at 3-month follow-up , 95. DatSH is an effective technique for the treatment of HD. When compared with conventional hemorrhoidectomy, SH is associated with less operating time, earlier return of bowel function, shorter hospital stay, less pain, a faster functional recovery with shorter time off work, an earlier return to normal activities, and better wound healing .However, the incidence of recurrence and the need for additional operations are also significantly higher when compared to conventional hemorrhoidectomy .Numerous studies on short-term outcomes have demonstrated that when compared to conventional hemorrhoidectomy, SH is quicker to perform and patients experience less postoperative pain, postoperative bleeding, wound complications, and constipation -101. HosThe higher recurrence rate was confirmed by a recently published retrospective study that analyzed the long-term outcome (15-year follow-up), of 257 patients who underwent SH . Follow-.SH is more expensive than traditional excisional surgery. The cost–utility analysis indicates that SH has < 0.1% probability of being cost-effective at £20,000 and 0.1% probability of being cost-effective at a £30,000 willingness to pay threshold  .Although all major prospective randomised trials have failed to demonstrate any significant adverse event related to the use of SH, in up to 10% of these patients, several complications were observed . NumerouTransanal hemorrhoidal dearterialization (THD) or Doppler-guided hemorrhoidal artery ligation (DGHAL)THD or DGHAL is a treatment option for II- and III-degree haemorrhoids and in experienced hands possibly also for IV degree [.V degree , 109 .p = 0.710) [p = 0.09) [.Following THD, fewer patients had postoperative bleeding compared with open hemorrhoidectomy or SH. THD is associated with fewer emergency reoperations than open, closed, stapled and LigaSure™ procedures, with a high probability of being the best treatment regarding this outcome (= 0.710) . In addi= 0.710) . Work or = 0.09) . However = 0.09) , 113 .When compared to SH, THD was associated with significantly less postoperative pain. Both techniques were equally effective in the short term with similar rates of complications and recurrence , 117-120The recurrence rate following THD/HAL seems to be influenced by surgical experience. Overall recurrence rate ranges between 3 and 24%  with reintervention, to treat recurrent symptoms, necessary in 2.7–22% of patients  [The use of a mucopexy has become a routine part of the procedure though, in patients with bleeding as the only symptom, dearterialization alone may suffice. In the presence of any degree of hemorrhoidal or mucosal prolapse, mucopexy should be added to the dearterialization. A THD technique with targeted mucopexy has been described as the best way to tailor this procedure to each individual patient .Pain following THD can occur in up to 38% of operated patients . Yet, in the majority of series, the incidence of postoperative pain was less than 10%. Postoperative bleeding was reported in up to 18% of patients  and, in rare instances, required hospital admission and reintervention. Other postoperative events include tenesmus, which is more frequent in patients who underwent mucopexy, hemorrhoidal thrombosis, observed in up to 8.6% of patients , and anal fissure . Transient fecal urgency has also been reported ..The traditional excisional methods  still remain the first choice and the most common indication for symptomatic III- and IV-degree HD .Open hemorrhoidectomy (OH) and closed hemorrhoidectomy (CH) are both efficient surgical procedures for the treatment of HD, despite the presence of some disadvantages due to the extent of dissection as well as to the presence of wounds below the dentate line with postoperative pain that can be severe delaying the return to normal daily activities. According to a recent meta-analysis  of 11 RC.Radiofrequency hemorrhoidectomy is a sutureless technique dependent on a modified electrosurgical unit to achieve tissue and vessel sealing. It results in less blood loss, postoperative pain, and complications. It is technically simple, because suturing is not required and hemostasis is easy to achieve . It has Pain following hemorrhoidectomy is well described in the literature and seems to be less after radiofrequency hemorrhoidectomy -125. PosThe prevalence of symptomatic hemorrhoids is higher in pregnant than in non-pregnant women.Pregnancy and spontaneous vaginal delivery are well-established predisposing factors for the development of HD in females due to the increased intra-abdominal pressure from uterine growth, the hormonal changes, and constipation . Clinical reports demonstrated that HD is mostly prevalent in the last trimester of pregnancy and in the first month after delivery, with about 25–35% of the pregnant females suffering from this disease , 128. In.Patients with I- and II-degree HD may benefit from oral rutosides for symptom relief. However, their use cannot be recommended until new evidence about their safety is available  (Level op < 0.005) [.Sitz baths have been shown to be a statistically significant choice in achieving a complete healing of HD in pregnant females compared to conservative treatment with an anorectal cream (< 0.005) –134 .Although there is a tendency toward conservative treatment, hemorrhoidectomy (CH) has been successfully performed without risk to the fetus . In fact.According to Mirhaidari et al. , an exciThere are no safety data available for any of the compounds commonly used for HD during pregnancy. Thus, it should be treated by increasing fiber and oral fluid intake, administering stool softeners, improving toilet habits, and sometimes by adding topical treatment .The course of HD tends to be longer during pregnancy and most symptoms will resolve spontaneously after delivery, with a few cases requiring a surgical evaluation during pregnancy or after delivery.TEH can be easily recognized on physical examination as usually tender visible blue perianal/anal lumps. TEH most frequently causes acute and severe pain, but the severity of the symptoms depends on the size of the thrombus. Without intervention, the pain typically gets better over 2–3 days, with a continuous improvement as the thrombus gradually absorbs over several weeks. Analgesics and stool softeners may be beneficial.Heparin treatment , a highl.Conservative treatment for prolapsed thrombosed internal haemorrhoids, if compared with urgent hemorrhoidectomy, is associated with a shorter inpatient stay and less anal sphincter damage than operative treatment  (Level op < 0.001) [.Excision has been shown to have better results in terms of reduction of pain, recurrences, and number of skin tags in comparison to simple incision and conservative treatment with glyceryl trinitrate (GTN) (< 0.001)  . This latter can be avoided by combining topical nifedipine and lignocaine rather than using lignocaine alone .A literature search  consider.Thus, most patients with TEH benefit from surgical excision within 72 h of the onset of symptoms  .These data were confirmed by Jongen and Coll  who condZuber  proposed.SH is a feasible treatment for selected patients with an acute hemorrhoidal crisis and has a similar complication rate if compared with a conventional excisional hemorrhoidectomy. SH is associated with less postoperative pain, shorter operation time, a shorter hospital stay, and an earlier return to normal activities  .However, older patients with anemia or a prolonged hemorrhoidal crisis are unsuitable for stapled hemorrhoidectomy  .Even if the indications for hemorrhoidectomy in patients with AIDS need to be considered extremely carefully because of the high incidence of delayed wound healing , nowaday.Recently, Fan and Coll  reportedIn conclusion, there is no evidence for the best treatment regarding HIV + patients with hemorrhoids. Further studies are requested to provide some scientific evidence. Moreover, no data of transplanted patients have been reported in the international literature.There is no consensus in the scientific literature regarding the exact indications for surgery in patients with IBD who have HD..D’Ugo et al.  suggesteThere is no consensus in the scientific literature regarding the exact indications for surgery in patients who have had pelvic radiotherapy for malignancy..Thornhill et al.  reportedAfter radiation in the pelvic region, most symptoms are linked to the radiotherapy and not to the HD. For this reason, any invasive procedure for benign disease, especially for hemorrhoidal-like symptoms, must be strongly discouraged .The frequent use of anticoagulants has likely led to an increased incidence of bleeding in patients with a clinically significant internal hemorrhoids. Society guidelines recommend that anticoagulation be suspended prior to hemorrhoidal surgery and procedures.However, there is no consensus regarding the exact indications for surgery in patients with HD affected by coagulopathy.. These results were confirmed by Atallah et al. [.As already described, Hite et al.  reportedh et al.  who reveh et al.  suggesteEmbolization of the hemorrhoidal arteries, the so-called “Embhorroid technique”, was first described for the treatment of HD in 2014 by Vidal et al. .It consists in the embolization of the hemorrhoidal arteries, in which arterial occlusion is achieved through an endovascular approach  using coils placed in the terminal branches of the superior rectal arteries. The use of polyvinyl alcohol (PVA) particles of 0.3 mm and metallic coils seems to be more effective in symptom relief than the use of metallic coils alone. In fact, the use of 0.3 mm particles determines a more distal hemorrhoidal plexus embolization reducing the reloads by the middle rectal arteries and avoiding rectal ischemia, because the particles do not pass the inferior rectal artery anastomoses ..It could be performed in an outpatient setting and has been shown to be a safe and effective technique for the treatment of II–III-degree HD  .It should be reserved for a selected group of patients with disabling and refractory hemorrhoidal symptoms and without irreducible prolapse  .Emborrhoid showed good bleeding control in patients with contraindications for conventional surgery with a clinical score improvement in 72% of cases after the first embolization session  .HeLP has been shown to be safe, effective, and easy to perform. It is an effective alternative for the treatment of symptomatic hemorrhoids, especially with bleeding and pain as prominent symptoms, in the absence of severe mucosal prolapse even if an improvement of the latter has been described. This procedure can be also associate with rectoanal repair or with mucopexy .This novel technique shares the rationale of the HAL and THD procedures but with the potential advantage of being less invasive and not requiring general anesthesia  .The most common intraoperative procedure-related complication reported is postoperative bleeding, ranging from 5.9% to 8.8% of cases with more than a half of them needing an hemostatic procedure , 166 .Symptoms recurrence ranges from 10 to 20% for II–III-degree HD , 168 (LeLaser hemorrhoidoplasty (LHP) is based on the application of the laser beam inside the hemorrhoidal tissue. After making a 1-mm opening at the cutaneous anal edge of the hemorrhoidal pile, the fiber is introduced inside the tissue parallel to the anal sphincter as well as to the rectal axis. The fiber is then pushed up to the upper part of the piles and three pulses at a power of 15 W are delivered. This maneuver is repeated thorough the same hole but in different directions. The laser beam induced a shrinkage of underlying tissues up to approximately 5 mm of depth ..LHP seems to reduce postoperative pain, intraoperative bleeding, and the need of postoperative analgesics if compared with Milligan–Morgan procedure, with a complete resolution of symptoms in about 70% of cases  .It is associated with shorter operative time and less postoperative pain compared to excisional surgery . Furtherp = 0.761) .After a mean follow-up of 5.4 years, recurrences was reported in 39% and 33% of patients with II- and III-degree HD, respectively , withoutOpen and closed hemorrhoidectomies have a significantly more severe negative impact in the early postoperative period than stapled, THD, LigaSure™, and Harmonic™ hemorrhoidectomies Various studies have shown that the closed and radiofrequency hemorrhoidectomies  had significantly more postoperative complications (mainly pain) than the open, stapled, LigaSure™, Harmonic™, and THD  procedures. Furthermore, OH and CH were associated with greater operative blood loss and a longer operating time compared with the other surgical techniques. Nevertheless, a low recurrence rate is perceived to be the most important advantage of OH and CH which were found to have a lower recurrence rate than THD and SH. Moreover, the use of energy devices such as LigaSure or Harmonic may reduce complication rate, even if with increased costs . OverallThe overall complication rates after SH and THD were comparable with no significant differences , 176. DeEarly fecal urgency after SH has been reported, with incidence rates of 0—25%, and a median of 8% .On the other side, postoperative tenesmus was reported in up to 24% of patients and pruritus in up to 15% after DGHAL, especially if mucopexy was contemporary performed .Several studies described different complication rates following office procedures , ranging from 3% to 18.8% , 178. A Urinary retention is one of the most common complications after surgery for  HD, with incidence rates of 3–50% with most studies reporting a rate around 15% , 181.2.Emergency reoperation may be required in about 2% of patients after a surgical treatment for HD Up to 90% of emergency reoperations are needed to stop a postoperative bleeding. Interestingly, most patients will not have an identifiable source of bleeding by the time which they are examined in the operating room. However, these bleeding episodes can be significant and a return to the operating room for a second look may be justified. Intractable pain, hematoma incision, residual hemorrhoidal thrombosis, and sepsis are other possible indications for reoperation.A network meta-analysis of the trials reporting on reoperation showed that THD/DGHALprocedures were associated with significantly fewer reoperations than open, closed, stapled, and LigaSure™ procedures, in large part due to lower bleeding rate . However3.Bleeding: fewer people have postoperative bleeding after THD/DGHAL procedures compared with OH or SH For conventional hemorrhoidectomy (Milligan–Morgan and Ferguson) and bipolar energy device hemorrhoidectomy (LigaSure), rates of bleeding between 0 and 49% have been reported. Clinically significant bleeding has been reported in 0.3–6% of patients, with an average of around 2%, and need of reintervention between 1–2%, without a significant difference in rates of bleeding between the procedures , 183.Early bleeding was the most common complication after SH, with the overall rate following the procedure ranging from 0 to 68% (median 7.5%) with < 1% of postoperative bleeding requiring treatment , 184.Bleeding after Doppler-guided hemorrhoidal dearterialization has been reported to be low ; however, this needs to be balanced with the chance of long-term recurrence .Bleeding after RBL normally occurs between 5 and 14 days after treatment, probably due to the sloughing of the ligated hemorrhoids .However, when RBL was compared to HAL, recurrence rates (if RBL was repeated), symptom scores, complications (such as postoperative bleeding), quality-of-life score, and continence score were similar, although patients had more pain in the early postoperative period after HAL. HAL was also more expensive and was not found to be cost-effective compared with RBL in terms of incremental cost per quality-adjusted life-year .4. Pain: The higher levels of pain related to OH and SH compared to other techniques resulted in a longer hospital stay and a later return to normal activities. A multimodal pain reliever regimen should be used to promote a faster recovery, prevent urinary retention, and improve patient satisfactionCompared to excisional hemorrhoidectomy, THD and SH are followed by less postoperative pain. A number of modifications in surgical and postoperative management have been proposed and attempted to reduce the pain, with variable results.Topical 2% Diltiazem or GTN ointment demonstrated a significant pain reduction in randomized trials .Lateral sphincterotomy or botulin toxin injection also demonstrated efficacy in reducing postoperative pain, suggesting a possible role of sphincteric spasm in its pathogenesis. However, the risk of developing temporary or permanent anal continence alterations limits the use of sphincterotomy.The use of oral metronidazole in controlling postoperative pain was recently evaluated in two meta-analysis with conflicting results , 187.Several other treatments such as mesoglycan  were recThe reported incidence of postoperative pain ranged from 0 to 38% with a pooled value of 15% after THD procedure .Pain after SH has been attributed to the involvement of the staple line on the sensitive squamous epithelium of the anoderm, inclusion of smooth muscle, or surrounding anorectal tissue in the scar, and induction by the staple line of an inflammatory response in the rectal ampulla, sphincter or rectal spasm, elevated anal resting pressures, retained staples, fibrosis around the staple line, wound dehiscence, and sepsis. Although chronic pain after SH has been variably reported, it is typically experienced by less than 2% of patients.Treatment of chronic pain following HD surgery should be targeted to the underlying source. However, it is usually quite difficult to manage and cure, which emphasizes the importance of proper knowledge of the anatomy and careful use of surgical techniques.Warm sitz baths and non-steroidals therapies can relieve mild pain. Antispasmodics such diazepam or cyclobenzaprine may be added if levator spasm is noted. Post evacuatory pain may be treated with oral nifedipine. Anismus may be treated with botulinum toxin injection. For selected cases, sacral neuromodulation has also been described .In case of chronic pelvic pain after stapler surgery, the removal of staples or staple line excision has been reported , 190. HoUrinary retention after hemorrhoidectomy is often multifactorial, with pain as one of the major issues, causing symptoms through irritation of pelvic nerves and activation of pain-evoked reflexes.Some risk factors are not modifiable .In general, epidural and spinal anesthesia have been associated with higher rates of urinary retention compared with monitored anesthesia care. Opioids or excess intravenous fluid has also been shown to significantly increase the risk of urinary retention. Usually, most problems with urinary retention are self-limited, and will resolve without major intervention. An adequate control of pain is a key point in prevention and treatment. Patients with mild retention are often counseled to sit in a bath of very warm water, filled above the waist. When this is unsuccessful, patients may require bladder catheterization. This may involve intermittent straight catheterization or a temporary indwelling catheter, which can typically be removed after a few days without further testing. Α1 antagonists such as tamsulosin can be helpful, and attempts to minimize opioid intake is also worthwhile .5.Life-threatening complications: Although extremely uncommon, life-threatening complications have been reported after every treatment for hemorrhoids. Surgeons providing hemorrhoid treatment should be aware of the potential serious complications and alert to their presenting features Severe septic complications have been reported after all types of treatments of hemorrhoids, and their real incidence is probably underestimated.Complications such as rectal perforation, pelvic sepsis, abdominal peritonitis, pneumo-retroperitoneum or mediastinum, pulmonary septic embolism, liver abscess, and Fournier's gangrene, with several deaths, have been reported , 193.Several infectious complications have also been reported following office procedures  including pelvic sepsis, Fournier’s gangrene, liver abscesses, tetanus, and bacterial endocarditis. Deaths due to these infectious complications have been reported too .Even if surgery is usually considered mandatory after serious septic complications, and colostomy often performed, successful conservative treatments  have been reported in selected cases.Escherichia coli and Bacteroides are the predominant organisms that cause infection following hemorrhoidectomy. The efficacy of a routine use of prophylactic antibiotics has yet to be proven, although special consideration should be given in  immunocompromised patients.The majority of patients in whom these complications occurred were healthy before surgery, and no predisposing factors had been identified. However, it is well known that digital, surgical, or instrumental manipulation of the rectum is associated with a possible 0–9.5% of transient bacteraemia , often w6.Long-term complications: Anal stenosis, soiling, and alterations of anal continence or residual skin tags have been reported after all the treatments for hemorrhoids, without any significant difference among the surgical treatments Complications after hemorrhoid surgery are not always immediate, and can instead take months or years to fully develop. In general, they can be more severe and more difficult to treat than those occurring in the immediate postoperative period.Fifty-one trials  reported on the proportion of patients complaining of difficulty voiding owing to outlet obstruction or anal stenosis/stricture at follow-up .Anal stenosis has been reported after stapled or excisional hemorrhoidectomy in 1–7.5% of cases , 195. InPatients often report straining at defecation, smaller caliber stools, and pain at defecation. Anal stenosis may also lead to fecal impaction and overflow incontinence.Anal stenosis may be classified, according to the severity of the stricture, as mild, moderate, or severe, but its management is usually determined by the severity of symptoms rather than the degree of stenosis. Mild strictures can often be treated with dietary modifications, stool softeners, or fiber supplements. Digital dilatation or the use of anal dilators can be part of the treatment plan if medical management is not sufficient. Patients with moderate or severe strictures who have failed conservative management usually require surgical intervention. To determine the proper surgical procedure, the degree of involvement of the anoderm and the sphincter muscle complex must be determined. In case of fibrotic anal sphincter, sphincterotomy  may be considered. On the contrary, patients with stenosis of the anoderm are usually treated with flap (multiple types) or anoplasty, aiming to replace local fibrosis with healthy, elastic tissue . Flap prFifty-three trials  reported on the proportion of patients experiencing soiling or difficulty with hygiene or incontinence at follow-up after different types of treatment for HD .Incontinence to feces and/or flatus was reported, with an overall incidence rate of 0.1–17.8%. However, whether this complication was transient or permanent was often not clearly specified .Incontinence after hemorrhoidectomy is usually associated with partial- or full-thickness internal  anal sphincter injury, but it can occur also with intact sphincters, as the hemorrhoidal cushions are known to provide 15% of the patient’s resting anal tone, and their removal can be functionally disadvantageous. Excision of hemorrhoids with secondary healing may also cause decreased sensitivity and reduced capacity for rectoanal discrimination .Fecal incontinence can also occur after a procedure for prolapse and  HD (reported in up to 5% of patients), and it has been related to a low-placed staple line, to an injury to the internal sphincter due to the large diameter of the circular stapler, or to an alteration of anorectal sensitivity or compliance. In a prospective, randomized trial of 134 patients, de novo fecal incontinence at 1 year was reported in 2.5% of patients who had SH compared with 7.5% of patients who had a Milligan–Morgan hemorrhoidectomy .


Immune checkpoint blockade has revolutionized the treatment landscape in a multitude of advanced cancers.Previously, our group demonstrated that tissue TMB (tTMB) estimated by a 422‐cancer‐gene panel (GeneseeqPrime) in NSCLC patients is associated with clinical benefit from anti‐PD‐(L)1 therapies.A total of 108 patients with NSCLC were treated with anti‐PD‐(L)1 monotherapy agents at Sun Yat‐sen University Cancer Center between December 2015 and August 2017, data cutoff in January 2019. According to our eligibility criteria, which were the same as previously specified,Analysis of the entire cohort revealed inadequate performance of bTMB in predicting patient outcome. While increasing cut‐points of bTMB showed a clear monotonic relationship with progression‐free survival (PFS) outcome, significant PFS difference was found between bTMB‐high and ‐low patients only at cut‐points of 13 and above . In this regard, bTMB assessment identified less than 20% of patients who may derive PFS benefit, showing no enrichment of responders compared with the unselected population.P = .007) and no significant correlation with bTMB (Spearman ρ = 0.11). On the other hand, a strong correlation between ctDNA MSAF and bTMB was observed . Consistent with previous studies,P = .39; Figure S2B) and significantly prolonged PFS 1 blockade is unknown. Indeed, ctDNA release reflects tumor anatomic and metabolic burden,Although a strong correlation between tTMB and bTMB was achieved by excluding patients with low ctDNA release, whether such patients may derive benefit from PD‐1 therapies. Thus, rather than excluding the “low releasers” on the basis of inaccurate representation of bTMB, incorporation of MSAF status enriches for a large subset of potential responders. Given the association between ctDNA levels and prognosis in a number of cancer types,In conclusion, our study validated the clinical utility of panel‐estimated bTMB as a biomarker to identify NSCLC patients who may respond to immunotherapy. We also provided the first clinical evidence showing that matched tissue and plasma testing should be recommended when selecting patients for immunotherapy, as bTMB‐tTMB discordance negatively impacts prediction of clinical outcome. On the other hand, we identified ctDNA MSAF as a novel biomarker for predicting immunotherapy outcome. Importantly, low ctDNA release is associated with significant PFS benefit and integrated analysis of MSAF, and bTMB allows for a greatly enhanced enrichment of potential responders Figure . Our resThe authors declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported.National Key R&D Program of China ; Science and Technology Program of Guangdong (2017B020227001); Chinese National Natural Science Foundation ; Outstanding Young Talents Program of Sun Yat‐sen University Cancer Center (16zxyc04); Central Basic Scientific Research Fund for Colleges‐Young Teacher Training Program of Sun Yat‐sen University (17ykpy81).The study was conducted in accordance with declaration of Helsinki, and was approved by the Ethical Review Board of Sun Yat‐sen University Cancer Center. Informed written consent was obtained from each subject or each subject's guardian.Study concept and design: Zhang and Shao. Analysis and interpretation of data: Fang, Ma, Yin, Zhou, Wang, Bao, Wang, Wu, Hong, Yang, Huang, and Zhao. All authors were involved in the drafting, review, and approval of the report and the decision to submit for publication.Supplementary informationClick here for additional data file.


Background: National data demonstrate a trend toward outpatient same-day mastectomy. The possible drivers of this change include the costs related to hospital admission and effective management of postoperative pain. We retrospectively analyzed our single-institution experience with outpatient same-day mastectomy that incorporates a multimodal pain management regimen.Methods: We retrospectively reviewed the medical records of patients who underwent same-day mastectomy at a single academic hospital. All patients received a multimodal, perioperative pain management regimen consisting of the intraoperative administration of 1,000 mg of intravenous (IV) acetaminophen and 30 mg of IV ketorolac, combined with the operating surgeon performing a 4- to 5-level, midaxillary, intercostal nerve block using liposomal bupivacaine. All patients were discharged with a prescription for acetaminophen with codeine, along with options for nonnarcotic alternatives as needed for pain.Results: We reviewed the data on 72 patients who underwent mastectomies: 11 (15.3%) bilateral and 61 (84.7%) unilateral. The average age was 57 years, and average body mass index was 30 kg/m2. The average length of stay of 4 to 6 hours was a marked reduction compared to a 23-hour observational period or an inpatient hospital stay. The average follow-up was 20.1 weeks. Five patients presented to the emergency department (ED) within the 30-day postoperative period, with 2 patients (2.8%) requiring readmission to the hospital for non–pain-related issues. The other 3 patients (4.2%) were evaluated for specific pain-related issues but did not require admission and were discharged home from the ED.Conclusion: Our data support outpatient same-day mastectomy incorporating a multimodal, perioperative pain management regimen as a safe and feasible treatment option. Potential additional benefits may include decreased oral opioid use and cost savings for the hospital. In 2003, approximately 22% of mastectomies across 17 states were performed in a hospital outpatient setting, and the number increased to approximately 42% by 2012.2 However, an outpatient procedure can include a 23-hour observation, an antiquated definition of an outpatient length of stay.During the 8-year time period between 2005 and 2013, the rate of unilateral and bilateral mastectomies increased by 2-fold and 5-fold, respectively.3 Susini et al also reported a high level of patient satisfaction and substantial financial savings for the hospital system with outpatient partial mastectomy.3 A 2009 systematic review by Marla and Stallard of 11 observational studies revealed a high rate of outpatient same-day surgeries for partial mastectomy, ranging from 86% to 100%, with 8 of the 11 studies examining readmission rates.4 In the 8 studies, the acute readmission rate was 0% for 6 studies, 7% for 1 study, and 8% for the remaining study.A wealth of data shows the safety of outpatient partial mastectomy (lumpectomy), with low reintervention rates, as well as reduced patient anxiety and depression compared to inpatient hospitalization for mastectomy.6 Patient advantages include improved physical and psychological recovery at home; increased independence, comfort, and control in the postoperative recovery period; and reduced risk of hospital-acquired infections. Outpatient same-day mastectomy can also have a significant positive impact on cost savings and optimization of hospital resources related to inpatient bed availability.Data from 2019 strongly suggest that such results can be applied to patients who are undergoing mastectomy, with 2 large studies definitively showing that same-day mastectomy is not only feasible but also offers significant advantages for patients in the home recovery setting.13At our institution, outpatient same-day mastectomy incorporates a multimodal pain management regimen. Because of the public health awareness related to the misuse and potential abuse of prescription oral opioids, our unique pain management regimen was designed to provide the most effective and long-lasting perioperative and postoperative pain control possible. Given the high potential for opioid addiction and abuse in the postoperative setting, we wanted to minimize the amount and strength of prescribed oral opioids and limit the use of stronger oral opioids, such as oxycodone-acetaminophen (Percocet) and hydrocodone-acetaminophen (Norco).For this study, we wanted to determine if same-day mastectomy with the incorporation of a novel, multimodal pain management regimen is safe and feasible. If so, we planned to advance this approach throughout the health care system by developing an enhanced recovery after surgery (ERAS) clinical pathway and quality improvement (QI) project that could be applied across the United States in any breast surgery practice or hospital-based program.We retrospectively reviewed the medical records of 72 consecutive patients undergoing mastectomy and the same perioperative pain management regimen. This study was formally approved by the Louisiana State University Health Sciences Center Institutional Review Board (IRB Protocol #10215). Patients received either unilateral (n=61) or bilateral (n=11) mastectomy performed by a single surgeon (A.I.R.) at a single institution between November 2015 and July 2017. Thirty patients had a unilateral mastectomy with a concomitant sentinel lymph node biopsy, 27 patients had a unilateral modified radical mastectomy only, and 4 patients had a unilateral modified radical mastectomy with a contralateral breast procedure .All patients had a single, 15-French, fully fluted round drain placed along the inferior skin flap and extending into the axillary region for each breast for which a mastectomy was performed. For each case intraoperatively, the surgeon performed a multilevel, intercostal, midaxillary nerve block under direct visualization, using a total volume of 80 mL of liposomal bupivacaine . We used a 21-gauge needle or larger to avoid disrupting the liposomes, with the total volume of 80 mL aliquoted into four 20 mL syringes.Once the mastectomy and the axillary operation were completed, the wound was irrigated and hemostasis obtained. The single drain was then placed and sutured to the skin within the axilla for each breast for which a mastectomy was performed. The intercostal rib space within the midaxillary line and chest wall was identified and palpated. The needle was directed toward the inferior aspect of each rib, injecting approximately 5 mL of the liposomal bupivacaine into each rib neurovascular bundle. This process was repeated to the ribs above and below, so that a 4- to 5-level intercostal nerve block was completed . A remaiAs part of the multimodal pain regimen, we administered a single, intraoperative dose of intravenous (IV) acetaminophen 1,000 mg and the nonsteroidal anti-inflammatory drug (NSAID) ketorolac 30 mg. All patients received the same regimen of perioperative/postoperative pain management. All patients were allowed to shower the next day with the occlusive dressing in place. Our closure consists of completely absorbable sutures, with the third layer of closure comprised of liquid adhesive, such as a cyanoacrylate derivative. The mastectomy incision is covered with a small-width layer of a nonadherent dressing and an occlusive, water-resistant transparent film dressing .Patients were discharged home from the postanesthesia care unit (PACU) the same day as their operation, usually within a 4- to 6-hour time period. All patients were given the option of either over-the-counter ibuprofen 600 mg, acetaminophen 1,000 mg, or a 6-day prescription for acetaminophen with codeine to be taken every 4 to 6 hours as needed for pain.We examined patient demographics, type of mastectomy, tobacco use, and 30-day return to the emergency department (ED) and the reason for the visit.2. The majority of patients were African American (66.7%)  .The average follow-up for all patients was 20.1 weeks. Five patients (6.9%) presented to the ED within the 30-day postoperative period, and 2 (2.8%) required hospital readmission . One pat24 Goodman and Mendez were among the first to describe the consistent use of outpatient mastectomy, relying on a long-acting local anesthetic without epinephrine, specifically 0.5% bupivacaine hydrochloride, that was injected throughout the operative site into the surrounding soft tissues, as well as around the long thoracic, thoracodorsal, and intercostobrachial nerves.25 Other studies have reported high rates of patient satisfaction in conjunction with an organized and thorough patient education program focused on teaching patients how to manage and care for their drains at home.25The overall number of patients undergoing mastectomy who are discharged home after an outpatient same-day procedure is increasing in the United States and Canada. This trend has helped to minimize inpatient hospital admission; maximize hospital bed utilization for sicker patients; decrease the overall total cost of care; and eliminate the potential for hospital-acquired infection, medication errors, and the potential for oversedating or overdosing with IV opioids.5 The pathway was implemented in 13 hospitals across Alberta, with educational booklets, group classes, and other resources developed for providers, patients, and their families. After implementing this pathway, Keehn et al reported a substantial change in the percentage of patients undergoing same-day mastectomy, from 18/1,066 (1.7%) in 2001-2012 to 441/923 (47.8%) in 2018-2019.In 2019, Keehn et al reported that same-day mastectomy surgery using a perioperative care pathway and QI initiative was safe and well accepted in Alberta, Canada.5Of note, the percentage of unplanned presentations of postoperative patients to the ED was high in the Keehn et al study, with 22% to 27% of patients presenting to the ED within 30 days of their operation during a 3-year time period. The unplanned hospital readmission rate was 3% to 6% during the same time period. However, neither metric was found to be statistically significant when compared to an overnight or longer hospital stay. Using same-day mastectomy as a QI initiative resulted in the release of an estimated 831 bed-days per year across the hospitals involved in the study. In voluntary patient reports of their experience with same-day mastectomy, approximately 90% of patients responded with “excellent or good” regarding the plans to go home, caring for themselves, drain care, incision care, and other support issues. Cost-estimated disparities were not evaluated in the study.6 This large study included 84 surgeons performing 1,380 mastectomies, with 25% of patients undergoing bilateral mastectomy and 31% of patients having immediate implant-based reconstruction. Prior to implementing SHR, 23% of mastectomies were outpatient procedures, compared to 61% after the SHR implementation. This true change in clinical management was not associated with any significant differences in ED visits, reoperation, or hospital readmissions compared to an overnight hospital stay. Of note, the 5.2% rate of ED visits in the Vuong et al study was lower than the rate in the Keehn et al study and similar to our rate of 6.9%.In a similar fashion, Vuong et al initiated a pilot project across 21 medical centers in the Kaiser Permanente Northern California health care system to examine the feasibility and utility of same-day mastectomy, termed surgical home recovery (SHR).6The Vuong et al SHR checklist provides a cursory overview of their pain management regimen, ranging from the availability of regional blocks , intraoperative administration of a lidocaine drip and IV acetaminophen, postoperative minimization of nausea with limited use of narcotics intraoperatively, and postoperative use of a scopolamine patch. Expectations were set with all patients preoperatively, with a focus on what to expect after surgery and on plans to minimize pain and discomfort, managed with nonopioid alternatives such as acetaminophen, NSAIDs, and local anesthetics such as arnica cream.18 The use of a long-acting bupivacaine infiltration has been shown to provide a marked opioid-sparing effect, especially within the first 48 hours following surgery.26Our single-institution experience with outpatient same-day mastectomy provides additional evidence and justification for implementing a QI project with an ERAS-driven protocol for same-day mastectomy. We believe that same-day mastectomy using a multimodal pain management regimen will result in a paradigm shift in our current care model for mastectomy patients across the United States. As mentioned previously, many of the outpatient mastectomy cases performed in prior years, and even today, are actually 23-hour hospital stays. Many patients stay beyond this time period, resulting in inpatient stays of 1 to 2 days in many cases. The studies by Keehn et al and Vuong et al strongly support a paradigm shift toward same-day mastectomy, ranging from 48% to 61%, which is most notable for the interval change toward a shift to same-day mastectomy with implementation of a QI protocol for pain management. Thus, a realistic endpoint for many organizations or surgeons may be to simply effect a positive net change in their practice patterns from a 23-hour observational stay toward same-day mastectomy. ED visits, postoperative complications, and readmission rates are all comparable to an inpatient hospital admission of at least 23 hours.25 Implicit in all of these studies, including ours, are the potential downstream cost savings derived from lower incidences of nosocomial infections, hospital overdosing with IV narcotics, wrongly administered medications, and the costs associated with having to manage these unexpected complications. Consideration should also be given to the cost differences associated with a same-day procedure and an average length of stay of approximately 4 to 6 hours vs a 23-hour observational period or longer.In terms of overall hospital costs, none of the studies cited in the discussion address potential cost savings of same-day mastectomy for the hospital or health care system. Early discharge after mastectomy has been described since the 1980s. Studies suggested the safety and economic advantage of discharge after 4 to 5 days as opposed to 9 to 10 days.25 Another study found that the cost of an outpatient modified radical mastectomy was reduced by approximately 75%  when compared to the average 3-day inpatient stay.21 Little et al examined valuation and cost minimization with the use of liposomal bupivacaine in breast reconstructive surgeries and found a significant decrease in hospital length of stay, total costs, and rate of 30-day hospital readmission, suggesting a favorable economic profile.27 Little et al identified an estimated total cost savings of $11,510 per patient, with a direct cost savings of $6,399 per patient.Goodman and Mendez showed that an additional 2 to 3 days in the hospital added approximately $3,000 of cost for each patient.Some unique aspects of our single-institution experience with same-day mastectomy are worth noting. To the best of our knowledge, we are the first to report the incorporation of an intraoperative, surgeon-guided, multilevel rib/intercostal nerve block using liposomal bupivacaine as part of a perioperative multimodal pain management regimen. Liposomal bupivacaine appears to be the longest acting local anesthetic formulation available as of May 2020, with a range of duration of approximately 2 to 4 days based on our anecdotal experience with this study. The other aspects of the multimodal pain management regimen also appear to be unique, with no identified studies or citations of such a combination in the current (as of May 2020) literature.This pain management regimen, combined with properly setting expectations and providing patient and family education, has translated into a safe, feasible, and highly successful approach to same-day mastectomy. In terms of postoperative oral opioid use, we have found that patients no longer need to be sent home with anything stronger than a few days’ prescription for acetaminophen with codeine. When given the option, many patients preferred no oral narcotics whatsoever, instead electing to take nonopioid alternatives, such as acetaminophen, ibuprofen, or another over-the-counter NSAID. However, we did not formally assess which patients chose which option in our retrospective review and cannot draw any firm conclusions as to the effectiveness of this pain management regimen.We recognize some notable weaknesses of our study. We were unable to gather information related to patient-reported outcomes, such as overall patient satisfaction, postoperative pain levels each day, and comfort level with managing the drain at home. This information was not in the medical record in most instances; either it was not recorded or not discussed during the follow-up visits. Because our study was a retrospective review of prospectively followed patients, we did not provide patients with postoperative questionnaires addressing levels of pain or overall satisfaction. Therefore, we cannot draw conclusions as to the effectiveness of pain control or patient satisfaction beyond a patient's verbal anecdotal experience. Finally, we were unable to obtain accurate financial data related to cost savings associated with same-day mastectomy.A few subtle but very important points are instrumental to the overall success of implementing a same-day mastectomy ERAS protocol. Once mastectomy is agreed upon as the recommended surgical approach, we discuss, in detail, all aspects of the patient's surgery with both the patient and family, focusing on what to expect after the operation is completed. We discuss the details of the multilevel intercostal nerve block, as well as the reasoning for why an overnight stay is not required with this approach. We further discuss and review the expected postoperative recovery experience, with the goal of a 4- to 6-hour total recovery before going home. The type of oral pain medication that the patient will be discharged home with is discussed, with nonopioid alternatives offered according to patient preference. We discuss the multiple advantages of going home the same day of surgery: decreased exposure to potential sources of hospital-based infections, not having to eat the hospital food, not being woken up in the middle of the night for vital signs and drain care, and sleeping in their own beds in the comfort of their homes. In addition, we discuss drain care management and range-of-motion exercises with every patient. An important part of this protocol is education of the patient and family members on how to properly manage the drain in the home setting.The breast program nurse navigators at our center are instrumental with helping to educate patients and family members at several possible touch points throughout their experience. A patient may see a breast program nurse navigator prior to the scheduled operation, which is the preferred method in most cases. Sometimes, the patient will be seen again in the PACU and just prior to discharge to ask any last questions or review details about drain care. Additionally, our occupational and physical therapists see each patient and provide a booklet of range-of-motion exercises to perform daily at home.Our single-institution experience with outpatient same-day mastectomy, highlighting the use of a novel multimodal perioperative pain management regimen, shows that same-day mastectomy is safe, feasible, implicitly cost-effective, and likely associated with several potential advantages of self-care in the home setting. These results, supported by large, multi-institutional studies in 2 countries, show the success and utility of implementing a QI project and ERAS-driven pathway toward same-day mastectomy. Such a pathway, enhanced with a multimodal perioperative pain management regimen, can be potentially applied to implement a change in clinical practice from a hospital stay of 23 hours or beyond to an approximate 4- to 6-hour stay in the PACU and discharge to self-care at home. Future studies should focus on further refinement and optimization of pain management regimens, patient satisfaction, cost savings, and the eventual elimination of or need for oral opioid use in the postoperative home setting.


Extensive waiting times before receiving services is a major barrier to adequate pain management. Waiting times may have a detrimental impact on patients’ conditions and quality of life. However, there remains a lack of knowledge on the actual experiences of patients waiting to receive services, especially for those with rheumatic conditions. The present study aimed to gain an in-depth understanding of perceptions and experiences of patients with rheumatic conditions regarding access to pain clinic services. The secondary objective was to identify possible solutions to improve this access according to patients’ perspectives.This qualitative study based on semi-structured interviews was conducted with adults with rheumatic conditions waiting to access pain clinics in the province of Quebec, Canada. Interviews were transcribed verbatim and analyzed using thematic content analysis.Twenty-six participants were interviewed . Four main themes were identified: 1) the perception that waiting time is unacceptably long; 2) how the lack of information affects patients’ experiences of waiting; 3) patients’ various expectations towards the pain clinic, from high hopes to disillusionment and 4) carrying an emotional, physical and financial burden resulting from the wait. Participants reported several solutions to improve the experience of waiting, including providing information to patients, increasing resources, improving prioritization processes and care coordination, and providing alternative interventions to patients during the wait.For patients with rheumatic conditions, access to pain clinic services is challenging due to extensive waiting times. The burden it imposes on them adds to the existing challenge of living with a chronic rheumatic condition. The solutions identified by participants could serve as building blocks to develop and implement measures to improve patients’ experience of accessing pain-related services.The online version contains supplementary material available at 10.1186/s12913-021-06114-y. Chronic pain is an important cause of disability, affecting one in five individuals among North American and European populations –3. For aHowever, access to multidisciplinary pain management programs is challenging and long waiting times have been reported in pain clinics in many countries –22. A rehow and why patients are affected by the waiting period. Such questions are best answered by understanding patients’ perceptions and experiences shared through their own voices. Such knowledge is important to guide the development of effective and meaningful measures to improve patients’ experiences of access to services.Delays in accessing services in pain clinics may have detrimental consequences on patients’ health and well-being. Waiting times longer than 6 months before receiving chronic pain treatment have been associated with worse health-related quality of life among patients with different chronic pain conditions  and a smThus, the aim of this study was to gain an in-depth understanding of perceptions and experiences of patients with rheumatic conditions regarding access to pain clinic services in the province of Quebec, Canada. The secondary objective was to identify possible solutions to improve patients’ experience of access to these services according to their own perspective.Institut de réadaptation en déficience physique de Québec Ethics Committee (#EMP-2015-449). The study is reported in line with the COREQ guidelines  aged 18 years or over; 2) diagnosed with a rheumatic condition ; 3) able to communicate orally in French or English, and 4) waiting for an appointment in a pain clinic OR referred to a pain clinic OR received services in a pain clinic in the past 6 months in Quebec, Canada. This 6-month time frame was chosen to minimize recall bias . A “painParticipants were selected based on a combination of sampling methods that aimed to reach a diversified and comprehensive sample of patients with a broad set of perceptions and experiences regarding access to pain clinic services –32. FirsPotential participants interested in the study contacted the research team by email or telephone; then, the objectives of the study were explained, the inclusion criteria were verified, and the interview scheduled. With an initial targeted sample of approximately 25 to 30 participants, recruitment continued until data saturation was reached, whereby no new theme stemmed from the interviews and the density and depth of the data were considered sufficient to answer the research objective , 33.Semi-structured interviews lasted on average 45 min (ranging from 15 min to 2 h) and were conducted by SD  and NB . Interviews took place either in person (at the participant’s home or the research centre) or over the phone, depending on participants’ place of residence and preference. An interview guide , 22 women and four men. The mean age was 54 years (standard deviation = 10 years), ranging from 39 to 82 years (see Table Four main themes emerged through the perceptions and experiences of access to pain clinic services expressed by the participants: 1) perceiving the waiting period as unacceptably long; 2) how the lack of information affects their experiences; 3) having various expectations towards the pain clinic, from high hopes to disillusionment and 4) carrying an emotional, physical and financial burden resulting from the wait. With the long waiting times at its core, the experiences of access were shaped by these four themes which were inter-related, as illustrated in Fig. The majority of participants shared negative perceptions of the waiting period. Many of them thought that waiting for many months and years was too long and was a difficult overall experience for them: “access to pain clinics is really too long” (A019), “too long because we are suffering right now, and the sooner we have access, the sooner we will at least have a few solutions [to treat pain]” (A023). Participants found it “very difficult to be in a dynamic of wait” (A001). The language used by some participants illustrates the emotions behind the negative perception of wait: “it is f***ing long” (A014), said a woman who had to wait for 2 years before her first appointment. Thus, participants viewed the waiting period as unacceptable: “These are people that suffer like martyrs and they leave them at home without support” (A014). They used various words to describe this time: “indecent” (A001), “abominable” (A012), “terrible” (A022) and “ridiculous” (A015). “It does not make sense,” said a woman who had been waiting 8 months (A011), a feeling of disbelief and dismay that was echoed by a few other participants: “I cannot believe that it is three years of waiting for the pain clinic, I cannot believe it” (A016). Another participant said: “It does not make sense to mess around with people like that.” (A014).Additionally, some participants had been waiting for so long they did not believe they would receive services anymore. This led some participants to question whether the expected benefits of treatment at the pain clinic were worth the wait, and even disregarded the pain clinic as a possible option to manage their pain. As they were not able to count on the pain clinic to receive services due to extensive waiting time, participants reported a feeling of hopelessness: “I don’t have hope for the pain clinic. This is my feeling. I don’t hope, I don’t count on it. I don’t count on it, I told myself, ‘If I wait for this, I will never go back to work, I will never go back to my life’.” (A022).The perception of the waiting time as an endless delay before treatment seemed to lower the expectations of obtaining positive outcomes from services offered at the pain clinic. As a result, some participants turned their back to the clinic and looked for alternatives.Participants also reported a sense of distance between them and the pain clinic, due to long waiting times and lack of information: “I have the impression that I am in Europe and [the pain clinic], they are in Canada or I don’t know. And when I talk to others, all the people whom I met in chronic pain, [ …] it’s always that, [they feel] it’s far away.” (A004) This geographical distance metaphor illustrates the disconnection between the pain clinics and the patients’ needs.Conversely, some participants seemed to accept the wait and perceived it as inevitable. This perception could be explained by previous experiences of waiting for other services that made it seem normal to wait for health care. The few participants who accepted the waiting period pointed to the large number of persons with chronic pain and the lack of human resources in the healthcare system. One participant noted: “It is maybe more the lack of personnel, we know it’s a major problem in Quebec, we know we have problems with personnel.” (A016) In some cases, however, the acceptance of waiting was preceded by a phase of negative feelings and psychological distress, as expressed by one participant: “I wait and I tell myself well, then we’ll just see what happens. When it will happen, it will happen. [ …] So you know, I don’t put emphasis on all of this anymore, I don’t spend negative energy anymore by making myself sick or crying or arguing on the phone or …” (A011). This participant also expressed a negative perception of the waiting period, suggesting a state of resignation to the situation rather than pure acceptance.Only two participants described a positive perception of their waiting period, one who was satisfied to have his first appointment within 3 weeks and another woman who felt the delay allowed her to progress in the meantime and be more prepared when she would eventually access the pain clinic.According to most participants, the information provided by the pain clinic during the wait was often insufficient, and this issue was considered a key element of their experiences of access for pain clinic services. They reported insufficient information regarding the services they would receive from the pain clinic, the prioritization process used and the estimated duration of time they would have to wait. This lack of information affected patients’ expectations towards the pain clinic and contributed to the emotional burden related to waiting.Most participants reported having received very little information regarding the pain clinic and wondered what type of services they would receive, how many appointments they would require, which healthcare providers they would meet or what benefit they should expect. This lack of information led to dissatisfaction among participants. One of them said: “you are like a number and they don’t keep you informed of the details, they don’t give you the information” (A012). This citation is an example of how participants reported being left alone and feeling unimportant to the healthcare system. Another participant expressed this feeling of abandonment due to the lack of information by saying: “there is no way to know anything [ …] it’s as if I did not exist at all” (A023).Many participants also reported a lack of information regarding the wait list. Some did not receive any confirmation that their referral had been received or that their name was still on the pain clinic waiting list after a few months or years of waiting, which created an uncertainty that was a source of anxiety for many participants during the waiting period. They also wondered how patients were prioritized to access pain clinic services. While most participants understood that patients with more urgent needs should be treated first, they asked for transparency with the prioritization process in order to help them better accept the situation. For example, informing them on their priority level and the prioritization criteria could help them understand why they had to wait for so long. In addition, they did not know how long they would have to wait or what rank they were on the list, which prevented them from planning their waiting period based on the expected delay. For example, one participant would have looked for alternatives instead of waiting passively, had she known the delay would exceed 6 months. Information on the duration of wait was also perceived as valuable because it gave participants a sense of hope: “I wished I had known if my case was progressing, if my waiting period was reduced, if I was at 6 months, one month, someone to tell me I had 6 months left, something like that to encourage me.” (A003) On the other hand, participants who were told that they had to wait a few years felt demoralized and had lost hope of being admitted to the pain clinic. Similarly, being told that her case was considered as a low priority led to “extreme frustration” for a participant (A007). Some participants had heard of long waiting times from other patients, as one participant expressed: “The only thing I hear about the pain clinic is, my god the delay is so long. It is not even if they offer this or this or that, it’s the long delay. ‘Don’t send your referral there, the delay is long’” . (A030).In response to the lack of information provided, participants reported searching on internet or calling the clinic, but the information obtained was minimal. Some participants were more active than others in asking for information: “I called once a month for a few months but they always answered the same thing, so at one point you get tired of it, I told myself, ‘what’s the point in calling?’” (A016) In some cases, the staff refused to provide information over the phone, such as estimated waiting duration or rank on the wait list, a situation that resulted in patient’s frustration.Another theme that emerged as reflecting participants’ perceptions and experiences of access to services at a pain clinic was their expectations towards these services, which were very different among participants. These expectations influenced patients’ experiences of waiting to access pain clinic services since they shaped emotions and perceptions of waiting, especially if the wait extended to several months or years.To start, several participants had no idea what to expect from the pain clinics in terms of services, outcomes, or healthcare providers, a consequence of the lack of information previously discussed. For some participants, the pain clinic represented the highest degree of expertise in pain management, where experts would provide advanced pain interventions and finally improve their condition after multiple other failed interventions. One participant illustrated this by saying: “They will give me, maybe give me a new medication, so look, I want that. But I know this is the last step, and after this is God, it is the sky. This is the last step.” (A001).Participants also had various beliefs regarding the interventions they expected to receive at the pain clinic and their outcomes. Many were looking for advanced prescriptions of third line medication or injection. Others wished to avoid medication and hoped for alternatives, for example, guidance for the use of cannabis or multidisciplinary management that included rehabilitation and psychological services, moral and social support and regular long-term follow-up of their condition. Regarding the outcomes following interventions, most participants anticipated an improvement in pain intensity, fatigue or disability. Others expected the pain clinic to be able to specify the diagnosis, even after multiple specialists’ opinions . This was particularly the case for fibromyalgia patients, for whom understanding their condition was a challenge.Overall, expectations ranged from high hopes that the clinic would improve their pain condition ), while others had very little hope to improve and felt disillusioned regarding the benefits the pain clinic services would have. These varying expectations and hopes affected for some patients the degree of anticipation to receive services and thus the perception of waiting. For example, a participant noted: “I had so little hope about what they would achieve to do or find, that I did not have, I was not waiting with anticipation that they would call me.” (A015) They also affected how they experienced the services at the pain clinic once they obtained them. A woman with high hopes to improve her condition with the pain clinic services had to wait a couple of years before receiving services that ended up not meeting her expectations. In her own words, she “waited two years for nothing” (A025).According to participants, the experiences of access to pain clinic services resulted in a burden in terms of emotions, consequences on the physical conditions and costs. This burden was mainly caused by the long duration of the waiting period but was also influenced by the lack of information from the pain clinics as well as participants’ expectations and perceptions.Participants reported an emotional burden resulting from the waiting period characterized by negative emotions such as frustration, distress, anxiety and a feeling of abandonment. These emotions sometimes overlapped, and often changed over the course of the waiting period. One participant said: “The journey has been so long just to get [referred] to the pain clinic, and then it is impossible to get access to services once you get there. It’s as if they would tell us, ‘This is your chance, and once you get there the door is closed’. So yes, there has been some revolt, some anger, there has been everything. Until the point when I told myself, ‘Now, the anger is eating me inside, this is what’s going to get me into depression’. So that’s it, because I am helpless.” (A022).Frustration was expressed by many participants: “You shout a slang word because you wonder why they haven’t called back yet, and why … You know, and you suffer so much and you are there, still waiting for them. Why are they letting me suffer? You develop a kind of hate, not a hate but … a frustration.” (A012) This frustration was often associated with the lack of information mentioned earlier. A man reported being frustrated, “because of the system, because of the way people are treated, because of the ignorance.” (A003).Some participants mainly shared feelings of distress and sadness relative to the waiting period. One woman expressed how waiting time affected her: “this waiting disrupts your whole life, it is depressing” (A004). Another participant qualified a 3-year waiting period as demoralizing and chose to take this period 1 day at a time, just “like people who are quitting drinking” (A005). Some participants were emotional during the interview, and a few cried or held back tears.For others, the waiting time was a source of stress and anxiety. For example, one woman wondered every time she received a phone call if it was the pain clinic calling. She was also worried to miss a phone call whenever she was away from home. For one participant, the anxiety was also related to uncertainty in the duration of the wait and in the outcome of the eventual treatment. A participant noted that patients with chronic pain “don’t really need stress, because it increases the pain, it increases the fatigue.” (A023).The feeling of “total abandonment” (A003 and A019) was strongly related to the lack of information, the absence of follow-ups during the wait and the patients’ lack of control on their wait list situations. Feeling abandoned translated into a feeling of being “completely left alone” (A003) and being meaningless. As one participant said: “You know, you look at a chessboard, that’s it. We are the little pawn; we are not the knight or the queen or the king or anything. We are the little pawn and we die quickly in that because the little pawn, at one point, we remove them, we put them aside.” (A004) This feeling of abandonment was especially salient for a participant who reported being removed from the wait list after having waited several years. She felt like “something, I don’t know, that we put aside, a rag” (A004).Some participants, essentially those who were waiting more than 6 months, reported a deterioration of their health condition during the wait, such as a worsening of the pain intensity, quality of life, fatigue or activity limitations. A participant noted: “There are always consequences, because everything deteriorates [ …] one, it’s the pain, two, the chronic fatigue related to the pain, three, my capacity to concentrate, to have fun, just some fun in my life.” (A028). One woman said her physical capacity decreased to the point she needed a walking aid to go out. Another participant linked the increasing frequency of pain flare ups of her rheumatic condition with stress factors such as the waiting period. Conversely, one participant noted: “In my case, I am not more affected you know, in the sense that the disease did not progress faster. It progressed normally at its rhythm, but I am not worse physically” (A011). Yet, a few participants noted the importance of early pain management to slow down or stop the degenerative decline of chronic conditions such as rheumatic diseases. They wondered, “What if my pain had been managed from the beginning?” (A016), “Would I be at the point where I am right now? Would my pain have developed into fibromyalgia?” (A004). It was also mentioned that longer pain duration leads to higher risk that the condition “crystalizes”: “The more it goes, the worse it gets. And I won’t regain the flexibility when the … if I can finally have a treatment that works to stop or slow down the disease. But the damage that I have, it will stay there.” (A015).The extensive waiting time compelled patients to look for alternatives to pain clinic services to treat their pain, including in the private sector such as physiotherapy, acupuncture, psychology or physiatry. Paying for services, however, added a significant financial burden to some participants, and this was not an option for every one of them: “I would have gone to private services, but now I mean, I am cut to the throat. I am even thinking of selling the house, I don’t have a choice.” (A028) One participant considered borrowing money to pay for private services, while another said, “I have to look elsewhere and pay from my pocket for other treatments as well. So I impoverish at the same time. Not only have I been on sick leave for 20 months, but financially I am sinking.” (A022).Also, the waiting time was perceived as extending the duration of sick leave or work disability status in some cases, which can have important financial impacts. One participant explained: “The consequences, well it’s because if the pain management [clinic] could give me a response, and that it would go faster, I would not still be on sick leave, probably.” (A013) Another participant noted: “It sure has an enormous impact on people not to have access to resources quickly [ …] they are not able to work anymore, they have to go bankrupt, to lose their house …” (A015).Participants identified various solutions to improve the experience of access which included providing more information to patients, improving the prioritization of referrals and the coordination of care, increasing resources in pain clinics and offering alternative intervention during the wait.One key solution was directly related to one of the themes previously discussed, that is the lack of information. Indeed, many participants suggested that pain clinics should provide more information to patients in order to clarify expectations towards the clinic and facilitate the waiting period. Such information should also be shared to family physicians, who could inform their patients at the time of referral. Participants suggested explaining what a pain clinic is, its goal and the expected outcomes. This could help patients avoid unrealistic expectations  or understand why it is worth the wait (for those who stopped believing). A man participant said that patients who know what to expect would be more likely to look forward to receiving services at the pain clinic. Information provided to patients could also help reduce the stress and anxiety associated with the uncertainty of the waiting period. A simple phone call from the pain clinic could have an impact: “Anyway, me and the others too would find it maybe a little less long, the feeling abandonment, if we could be called.” (A008). Participants suggested being transparent with the expected duration of the waiting time. A phone call or an email telling them that they are moving up on the wait list and that their waiting time is decreasing could reassure and “comfort” patients, even if they are being told they still have 6 months left to wait. It could also “encourage” patients during the wait: “at least you see a delay, there is something at the end” (A017). One participant made a comparison with people waiting in line and noticing their turn is about to come: “it has a psychological effect, it fills you up with good mood, you tell yourself, ‘well finally it’s my turn’.” (A016) An estimation of the duration of the wait may also encourage patients to search for alternative treatments during the wait: “Me, personally it would tell me: ‘Ok, I have to wait for two years. Yes, it’s a little bit demoralizing, but however, in the meantime, what do I do?’ So the decision comes down to me, to do something.” (A017).In addition, a participant suggested to explain the reasons of the long waiting time. For example, knowing the way referrals are prioritized and the number of staff versus the number of referrals may help patients understand and accept their situation of waiting, or at least resign to it. Many participants would have appreciated a simple confirmation that their referral had been received by the pain clinic and a periodic follow-up that they were still on the wait list. One participant perceived that such practice was part of elementary customer service standards that are common in other sectors outside of health care and should be expected in pain clinics. A participant also suggested that a periodic follow-up could allow to update the patient’s condition and maybe change the priority accordingly. In terms of format, participants suggested information could be communicated to patients by different means: phone calls, information booklets, emails, postal mail, websites, group sessions during the wait, etc.details about the referral a confirmation that the pain clinic had received their referraltheir rank on the list or their category of prioritythe prioritization process and criteria to determine the priorityestimation of the duration of waitperiodic follow-up to confirm their name is still on the listservices provided by the pain clinics, healthcare providers available, interventions, the facilitiesexpected clinical outcomes of the pain clinic and the goals of the interventionwhat to expect during the first appointment the number and frequency of appointmentsThe information participants had wished to know included:Participants recommended improving the prioritization process by allowing patients to explain their condition and specific needs to complement the physician referral. A participant regretted that “someone decided that our priority is low and we don’t have any news for years [ …] there must be at least an evaluation with the patient …” (A003). Two participants compared it to the triage at the emergency department, where patients are evaluated before being given a priority level. Participants suggested various methods to take into account patients’ perspectives, either with an in-person evaluation, a telephone interview or by filling out a form.Better coordination of care was also suggested as a way to improve patients’ experiences of access. For example, improving communication between physicians would allow them “to collaborate and push towards the same objective, that is helping the patient reach the pain clinic” (A022). A better communication between the referring physician and the pain clinic could possibly result in an earlier referral, better prioritization, or redirection towards alternatives to the pain clinic if necessary. A participant said: “because if they talk to each other more, maybe we will have a place [at the pain clinic] more quickly, maybe there will be more clinics and maybe we will have more solutions.” (A004) Some participants also needed to be oriented around the healthcare system. One participant wished someone would have told her “‘Ok, now, you need to do this, you need to go there’ Because me, I think I tried by myself many things and now, I don’t know what to do anymore” (A005).A woman recommended having different levels of treatment at the pain clinic, for example a first line of physical therapy while patients wait for the second stage of the pain clinic trajectory, similar to a primary, secondary and tertiary care structure. With a preliminary treatment in place during the wait, “there would already be a faster management, the patient maintains hope” (A022). Similarly, two participants mentioned the need to establish smaller satellite clinics that would serve as a first line of services for patients with chronic pain. A woman noted that primary care services are not adapted to treat chronic pain and specialized services are not accessible, and that there is no in-between. Satellite clinics distributed across the province could also make pain treatment more geographically accessible. In addition, a centralized point of entry for referrals was suggested as a strategy to help orientate patients to the appropriate resource and to the clinic with the shortest waiting time.A frequent and straightforward solution mentioned by participants to improve access was to increase the resources at the pain clinics by hiring more staff  in order to meet the demand. For some participants, it was obvious that the number of physicians had to be sufficient enough to manage the high number of referrals: “They must find new physicians, find money, work more hours per week, meet some people, ask the government for money, they have to work things out to deal with the demand.” (A003). On the other hand, some participants acknowledged that there is a shortage of human resources in many areas of the healthcare system and that increasing resources would be easier said than done.As previously mentioned, many patients had to find alternatives to treat their pain as a consequence of the long waiting time. In line with this issue, participants recommended that pain clinics provide or refer patients to alternative resources to help them cope with their pain during the waiting period. These alternatives included other healthcare services , a booklet with physical exercises or advice to manage their pain . A woman suggested providing “psychological support from the beginning, it’s essential, otherwise the waiting, it’s a torture” (A022). A participant also suggested that these alternatives could be provided at the time of an initial evaluation appointment, similarly to pre-operative rehabilitation. Another alternative was group sessions during the wait to inform and educate patients with similar conditions.Among the other resources that patients could be referred to during the wait, associations of patients with chronic pain or arthritis were frequently mentioned by the participants. These organizations were perceived to be an important complement to the healthcare system, as they could provide conferences, workshops and webinars to support people living with pain . One man said it is the association that “did the most to help me, it is not the hospital”. (A003) He was very grateful for the support received by the association while he was waiting to access the pain clinic. Patient organizations, through events and social media activity, also helped reduce isolation and allowed patients to share their experiences. They create a sense of community, which could be particularly useful for patients during the waiting period. Participants suggested that pain clinics could coordinate with these organizations or at least share their contact information to patients, especially since primary care practitioners were not aware of these resources, according to participants.how and why patients are affected by the waiting period. In addition, participants shared potential solutions to improve patients’ experiences of accessing pain clinic services, a unique contribution of this study.This study aimed to gain knowledge on perceptions and experiences of patients with rheumatic conditions regarding access to pain clinic services. It allowed to understand Overall, the results revealed that most participants reported a difficult experience of accessing pain clinics. Long waiting times were at the core of this negative experience, which was characterized by four interrelated themes: 1) perceiving the waiting period as unacceptably long; 2) how the lack of information affects their experiences; 3) having various expectations towards the pain clinic, from high hopes to disillusionment and 4) carrying an emotional, physical and financial burden resulting from the wait. For instance, the lack of information received during the waiting period seemed to have influenced patients’ expectations towards the clinic and their emotions towards the waiting time, and in turn, the expectations affected the emotional burden resulting from the waiting period.A main theme characterizing participants’ experiences of access to pain clinic services was their negative perception of waiting time, which they considered to be unacceptably long. Participants condemned this situation, where vulnerable patients are put on hold for a long period of time. Such delays to access pain clinics were also reported as a source of dissatisfaction in a UK study, in which waiting time was perceived as a main barrier to access . The negwaiting for services but rather focused on the experience of patients attending the pain clinic.The lack of information was an important issue reported by participants’, which notably resulted in anxiety and unrealistic expectations. Similarly to our findings, Gjesdal et al. also found that patients receiving chronic pain care criticized the lack of information on available treatment and noted that primary care providers themselves had little knowledge of the available treatment options for chronic pain . Thus, mThus, waiting time, lack of information and expectations towards the clinic were related to one another and characterized participants’ experience of access. For example, patients who anticipate a major decrease in their pain level upon receiving services from the pain clinic may be seriously disenchanted when they find out such improvement is typically minimal , especiaIn our study, participants carried an emotional, physical and financial burden resulting from the wait. This burden can be particularly challenging for patients with rheumatic conditions, who also have to bear the burden of their chronic pain, where pain is often accompanied by loss of mobility, fatigue, sleep disorders and psychological distress , 9. WithWaiting time also imposed an additional burden on participants in terms of potential deterioration of their physical health, which in turn led to psychological distress, for example by exacerbating anxiety and frustration. This is in line with the findings from Lynch et al.’s systematic review on the consequences of waiting for chronic pain treatment, which describes a deterioration in psychological status and quality of life in patients waiting 6 months or longer . The autThe burden resulting from the waiting time also included financial consequences, as some participants needed to look for alternatives to the pain clinic, often in the private sector, although not everyone was able to afford such services. This situation was also reported in other studies on pain clinic services or other publicly funded healthcare services  in the UK, in which patients considered that opting for private sector was sometimes the only option when facing long delays , 46. HowAccountability for Reasonableness (A4R) framework [While further research is needed for an in-depth ethical analysis of access to pain clinics, the findings of this study raise potential ethical issues. For example, patients rarely understand the prioritization processes and the reasons why they have to wait for so long. There is a need for more transparency in this regard, as recommended by Daniels & Sabin in their ramework . Also, pThe present study highlights the need to reduce waiting time as well as to improve patients’ experience of waiting. Participants identified several solutions in this regard, including sharing more information with patients in order to reduce anxiety and clarify expectations towards the clinic and the services offered. For example, providing patients with an estimation of the duration of wait was found to reduce uncertainty and anxiety in patients waiting for surgery . This soParticipants also emphasized the need for a better coordination between pain clinic and primary care. This aspect was reported in another qualitative study by patients receiving chronic pain treatment as well as nurses from pain clinics in Norway . In someFinally, participants suggested providing alternatives for patients on the wait list, such as rehabilitation or psychological services, physical exercises, advice to manage their pain or information on patient associations. In a survey of a pain clinic in Ontario, almost half of patients waiting for services reported receiving written information on chronic pain management or being informed of local patient organization . Such inA first limitation of this study is the small number of men included in the study, which limited gender-based analyses. However, such imbalance is consistent with the characteristics of pain clinics population, in which two thirds of patients with rheumatic conditions are women . Second,Long waiting times represent a barrier to access pain clinic services in Canada. In this study, most participants reported a difficult experience of accessing pain clinic services. Their experiences were characterized by a perception that waiting time is unacceptably long, a lack of information provided to patients, diverse and sometimes unrealistic expectations towards the pain clinics and an emotional, physical and financial burden endured by patients. For patients with rheumatic conditions, the difficulty in accessing pain clinics along with the burden it imposes on them added to their existing challenge of living with their chronic condition. Nonetheless, according to participants, pain clinics could improve patients’ experience by sharing more information with them, by improving prioritization processes, by ensuring a better coordination of care and by redirecting patients to alternative treatment options during the wait.The findings of this study should be taken into account by managers and decision makers concerned with access to pain clinics . The resAdditional file 1. Table S1. Consolidated criteria for reporting qualitative studies (COREQ): 32-item checklist.Additional file 2. Interview guide


Antibiotics have been suggested as treatment for selected patients with chronic back pain, with or without leg pain, and in association with Modic changes type 1 (MC1) on MRI , would spread hematogenously to degenerated discs, where a “low-grade subclinical infection” would trigger an inflammatory reaction and cause MC1 .In this Swedish multicenter study, the presence of bacteria in discs/vertebrae was evaluated in 2 patient groups from 7 hospitals . SamplesThe study found no statistically significant difference in bacterial presence between the 2 groups. No association was seen between Modic changes and findings of bacteria or between back/leg pain and findings of bacteria or Modic changes.Findings of bacteria, or traces of bacteria, as described in previous studies, are most likely a result of contamination during the surgical procedure.In Denmark, the clinical relevance of Modic changes for back pain and function was evaluated in a cohort study with a 13-year follow-up period . In all,The study found no statistically significant differences in demographic data, BMI, smoking, back and leg pain at the start of the study, or at follow-up. Physical function measured with RMDQ was initially equal between the 2 groups, but statistically significantly better  at the follow-up in patients with Modic changes at the start of the study, 7.4 versus 9.6 (p = 0.02). Patients with Modic changes at the start of the study also had fewer sick days due to back pain during the study period, 9 versus 23.Modic changes on MRI in patients with back pain at study start were not negatively associated with back pain or functional level after 13 years.In Norway, the Danish study by Albert et al.  was larg3 months of treatment with amoxicillin showed no relevant clinical effect after 1 year in patients with chronic back pain and Modic changes.Based on current scientific evidence, where the 3 Nordic studies supply complementary findings, antibiotic treatment for back/leg pain with no signs of serious infection (discitis/spondylitis) cannot be recommended. It is important to counteract the development of antibiotic resistance in society due to antibiotic use without scientific evidence.This article has also been published in the Swedish Läkartidningen; 2020; 117: 20067.