Conservative Care For Patients Research Articles

Lumbar spine fusion surgery versus best conservative care for patients with severe, persistent low back pain.

People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians' views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial). An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials. There were 72 respondents, with a response rate of 9.0%. They comprised 39 orthopaedic spine surgeons, 17 neurosurgeons, one pain specialist, and 15 allied health professionals. Most respondents (n = 61,84.7%) chose conservative care as their first-choice management option for all five case vignettes. Over 50% of respondents reported willingness to randomize three of the five cases to either surgery or BCC, indicating a willingness to participate in the future randomized trial. From the respondents, transforaminal interbody fusion was the preferred approach for spinal fusion (n = 19, 36.4%), and the preferred method of BCC was a combined programme of physical and psychological therapy (n = 35, 48.5%). This survey demonstrates that there is uncertainty about the role of lumbar spine fusion surgery and BCC for a range of example patients with severe, persistent LBP in the UK.

Pre-trial qualitative work with health care professionals to refine the design and delivery of a randomised controlled trial on kidney care

BackgroundRecruitment to randomised controlled trials (RCTs) is challenging. Pre-trial qualitative research provides insights into the feasibility and acceptability of proposed trial designs and delivery; however, this is rarely conducted. This paper reports on work undertaken in advance of the Prepare for Kidney Care trial (formerly PrepareME), which compares preparing for dialysis with preparing for conservative care for patients with chronic kidney disease. The paper describes how the findings refined plans for the forthcoming trial.MethodsSemi-structured interviews were undertaken with health-care professionals involved in delivering or recruiting to the trial. Interview findings were considered in relation to observations of a patient advisory group workshop and introductory site visits, which were set up to present the trial to professionals involved in the internal pilot phase of the RCT. The use of findings and input from multiple sources was intended to support suggested refinements to the forthcoming trial. The findings were fed back to the trial management group and other expert stakeholders.ResultsSixteen health-care professionals were interviewed, and one patient advisory group workshop and six introductory visits to sites involved in the internal pilot were observed. The professionals interviewed included renal consultants, nurses and renal social workers. Key themes identified from the interviews, supported by the observations, were concerns around the eligibility criteria, the feasibility of the trial intervention, imbalances in the presentation of the trial arms, and anticipated recruitment issues arising from patients’ and clinicians’ preferences for one arm or the other. Changes to the design were made in response, including to the content of the intervention, the presentation of the trial arms and the name of the RCT.ConclusionsThis study highlights the value of carrying out pre-trial work with health-care professionals to identify issues with delivering the proposed trial. This work can be particularly valuable in trials of new interventions, for which the barriers to their integration into routine care are unknown. This work has important implications for facilitating the identification of further obstacles in the main RCT. We suggest that pre-trial qualitative work is undertaken to address design issues early on, in addition to ongoing qualitative research to monitor the emergence of obstacles affecting recruitment.

Effectiveness of an Ayurveda treatment approach in knee osteoarthritis – a randomized controlled trial

Ayurveda is commonly used in South Asia to treat knee osteoarthritis (OA). We aimed to evaluate the effectiveness of Ayurvedic treatment compared to conventional conservative care in patients with knee OA. According to American College of Rheumatology (ACR) criteria knee OA patients were included in a multicenter randomized, controlled, open-label trial and treated in 2 hospital clinics and 2 private outpatient clinics in Germany. Participants received either a multi-modal Ayurvedic treatment or multi-modal conventional care with 15 treatments over 12 weeks respectively. Primary outcome was the change on the Western Ontario and McMaster University Osteoarthritis (WOMAC) Index after 12 weeks. Secondary outcomes included WOMAC subscales; the pain disability index and a pain experience scale, numeric rating scales for pain and sleep quality, quality-of-life and mood, rescue medication use, and safety issues. One hundred fifty-one participants (Ayurveda n=77, conventional care n=74) were included. Changes of the WOMAC Index from baseline to 12 weeks were more pronounced in the Ayurveda group (mean difference 61.0 [95%CI: 52.4;69.6]) than in the conventional group (32.0 [95%CI: 21.4;42.6]) resulting in a significant between-group difference (p<0.001) and a clinically relevant effect size (Cohen's d 0.68 [95% CI:0.35;1.01]). Similar trends were observed for all secondary outcomes at week 12. Effects were sustained at follow-ups after 6 and 12 months. Results suggest that Ayurvedic treatment is beneficial in reducing knee OA symptoms. Further studies should be conducted to confirm the magnitude of the effect and to clarify the role of different treatment components and non-specific effects. REGISTRATION: at clinicaltrials.gov (NCT01225133; initial release 10/06/2010).

The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study.

To determine whether it was feasible to perform a randomized controlled trial (RCT) comparing arthroscopic hip surgery to conservative care in patients with femoroacetabular impingement (FAI). This study had two phases: a pre-pilot and pilot RCT. In the pre-pilot, we conducted interviews with clinicians who treated FAI and with FAI patients to determine their views about an RCT. We developed protocols for operative and conservative care. In the pilot RCT, we determined the rates of patient eligibility, recruitment and retention, to investigate the feasibility of the protocol and we established methods to assess treatment fidelity. In the pre-pilot phase, 32 clinicians were interviewed, of which 26 reported theoretical equipoise, but in example scenarios 7 failed to show clinical equipoise. Eighteen patients treated for FAI were also interviewed, the majority of whom felt that surgery and conservative care were acceptable treatments. Surgery was viewed by patients as a ‘definitive solution’. Patients were motivated to participate in research but were uncomfortable about randomization. Randomization was more acceptable if the alternative was available at the end of the trial. In the pilot phase, 151 patients were assessed for eligibility. Sixty were eligible and invited to take part in the pilot RCT; 42 consented to randomization. Follow-up was 100% at 12 months. Assessments of treatment fidelity were satisfactory. An RCT to compare arthroscopic hip surgery with conservative care in patients with FAI is challenging but feasible. Recruitment has started for a full RCT.

Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN).

IntroductionFemoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome.MethodsWe will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02).Ethics and disseminationEthical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer-reviewed publications, including Health Technology Assessment, and presented at relevant conferences.Trial registration numberISRCTN64081839; Pre-results.

Manual therapy and segmental stabilization in the treatment of cervical radiculopathy

Abstract Introduction: Cervical radiculopathy (CR) is one of the diseases that most affect the cervical spine, causing radicular symptoms in the ipsilateral limb. Conservative treatment aim recover of both mechanical and physiological functions through neural mobilization techniques, along with the activation of the deep neck flexors with cervical segmental stabilization, combining techniques of joint mobilization and manipulation, which seeks mobility improvement of crucial areas of the cervical spine. The objective of this study was to evaluate a multimodal treatment to enhance the outcomes of conservative care in patients diagnosed with CR. Methods: The sample consisted of 11 patients with CR, between 21 and 59 years old, 3 female and 8 male. It was recorded the Visual Analogue Scale (VAS) for pain, the Functional Development of the Neck Pain and Disability Scale (NPDS) and the goniometry during shoulder abduction. The intervention plan was composed by neural mobilization, intermittent cervical traction, pompages, stretching, myofascial inhibition techniques, manipulative techniques and cervical segmental stabilization exercises. After 12 weeks of treatment, subjects underwent a new evaluation process. Results: Before the treatment, subjects reported an average pain of 7 (± 1.48) in VAS, whose dropped to average 1.18 (± 1.99) (p &lt; 0.01). Functional disability evaluated in NPDS was 36 (± 10.95) before treatment decreasing to 11.45 (± 9.8) (p &lt; 0.01) after the treatment. Range of motion of the ipsilateral upper limb was restores by increasing from 9.2° (± 8.2) to 137° (± 24.4) (p &lt; 0.01). Conclusion: The proposed treatment approach was effective, significantly improving the results of analgesia and functional disability a series of cases of patients diagnosed with cervical radiculopathy. {#}

Abstract 169: IV t-PA May Result in Better Outcomes than Conservative Care in Patients with Mild Acute Ischemic Stroke and Large Vessel Occlusion

Introduction: Most patients with mild acute ischemic stroke (AIS) symptoms are excluded from acute stroke therapy (AST). Studies have shown that patients presenting with large vessel occlusions (LVO) and low NIH stroke scale (NIHSS) may have poorer outcomes than previously presumed. The optimal treatment strategy in this population is unknown. Methods: A retrospective chart review of patients with AIS presenting to our tertiary care center between 2010 and 2013 was carried out. Inclusion criteria included LVO as cause of AIS and initial NIHSS &lt; 8. Patients presenting &gt;24 hours after last known normal were excluded. Patient demographics, administered therapies and short-term clinical outcomes were analyzed. For patients lost to follow up, last known values were imputed. Favorable 30-day outcomes were defined as mRS 2, NIHSS 1 or at least 4 point decrease in NIHSS. Results: A total of 121 patients (56.19% males; mean age 63.85±14.08) met inclusion criteria. Anterior circulation was involved in 69.4% cases [MCA (46.28%), ICA (16.52%), ACA (2.47%), ICA-MCA (4.13%)] vs 33.88% posterior circulation cases [PCA (8.26%), Ba (5.7%), V (19%)]. Median admission NIHSS and pre-admission mRS were 4 &amp; 0 respectively, which were statistically significant predictors of favorable outcome. Only 23 patients (19%) received AST [IV t-PA: 13, intrarterial (IA) therapy: 6, IV + IA: 4]. AST patients had shorter time from onset of symptoms to evaluation (mean: 3.7 vs. 9.9 hours, p &lt; 0.001), higher NIHSS on arrival (median: 5 vs. 3, p = 0.024), and were more likely to have a history of stroke (39% vs. 18%, p = 0.049). The odds of a 30-day favorable mRS were 1.7 times higher in the treated group, although not statistically significant (95% CI: 0.58, 5.7; p = 0.333). Numbers in the subgroup analysis remained too small to reach statistical significance, but 85% of patients who received IV t-PA (and 70% with any treatment) had a favorable 30-day outcome versus 62% of patients with conservative care.Conclusion: Our study suggests that qualifying patients with LVO and mild AIS presenting early may have better outcomes if treated with IV t-PA. We propose that rapid evaluation of vessel status may support more aggressive treatment considerations in patients with mild AIS. Further prospective data is needed.

Disc degeneration after disc herniation: are we accelerating the process?

Study design: Systematic review.Study rationale: Disc degeneration is a common process starting early in life. Often disc herniation is an early step in disc degeneration, which may cause pain or stenosis. How quickly this subsequent disc degeneration occurs following a disc herniation and subsequent surgical treatment and whether certain spinal procedures increase the rate of degeneration remain unclear.Objectives: To investigate the risk of subsequent radiographic disc degeneration following discectomy, discography, and conservative care in patients with a first-time diagnosed herniated nucleus pulpous (HNP) and to ascertain whether this risk in these defined groups changes over time.Methods: A systematic review of pertinent articles published up to June 2012. Key articles were searched to identify studies evaluating the risk of subsequent radiographic disc degeneration following treatment for HNP. Studies that included patients undergoing secondary surgery for disc herniation or that did not use a validated classification system to measure the severity of disc degeneration were excluded. Two independent reviewers assessed the strength of evidence using the GRADE criteria and disagreements were resolved by consensus.Results: From a total of 147 possible citations, three cohort studies (class of evidence III) met our inclusion criteria and form the basis for this report. The risk of subsequent lumbar disc degeneration following standard discectomy was significantly greater compared with both microdiscectomy (48.7% vs 9.1%) and asymptomatic controls (90% vs 68%) in two studies with mean follow-ups of 5.5 and 25.3 years, respectively. Following conservative care for first-time HNP in the third study, the risk of progression of lumbar disc degeneration was 47.6% over the first 2 years of follow-up and 95.2% over the next 6 years of follow-up. In the same study, the risk of lumbar disc degeneration was shown to increase incrementally over the course of the 8-year follow-up, with all patients showing signs of degeneration at final examination.Conclusion: Standard discectomy in first-time lumbar HNP may increase the risk of subsequent same-level lumbar disc degeneration compared with microdiscectomy as seen in one low-quality study. However, disc degeneration is likely a natural, temporal consequence following HNP, as demonstrated in a second low-quality study. The overall strength of evidence for the conclusions is very low.

Cost and use of conservative management of lumbar disc herniation before surgical discectomy

Background Context Lumbar discectomy is one of the most common spine surgical procedures. With the exception of true emergencies (eg, cauda equina syndrome), lumbar discectomy is usually performed as an elective procedure after a prudent trial of nonoperative treatment. Although several studies have compared costs of definitive operative or nonoperative management of lumbar disc herniation, no information has been published regarding the cost of conservative care in patients who ultimately underwent surgical discectomy. Purpose The purpose of this study was to determine the financial costs (and relative distribution of those costs) associated with the nonoperative management of lumbar disc herniation in patients who ultimately failed conservative care and elected to undergo surgical discectomy. Study Design This is a retrospective database review. Patient Sample The sample comprises patients within the database who underwent lumbar discectomy. Outcome Measures The outcome measures were frequency of associated procedures and the costs of those procedures. Materials and Methods A search was conducted using a commercially available online database of insurance records of orthopedic patients to identify all patients within the database undergoing lumbar discectomy between 2004 and 2006. Patients were identified by American Medical Association Current Procedural Terminology code. The associated charge codes for the 90-day period before the surgery were reviewed and categorized as outpatient physician visits, imaging studies, physical therapy, injection, chiropractic manipulation, medication charges, preoperative studies, or miscellaneous charges. The frequency of each code and the percentage of patients for whom that code was submitted to the insurance companies were noted, as were the associated charges. Results In total, 30,709 patients in the database met eligibility criteria. A total of $105,799,925 was charged during the 90 days preoperatively, an average of $3,445 per patient. Average charge for discectomy procedure was $7,841. Charges for injection procedures totaled $16,211,246 or 32% of total charges, diagnostic imaging $15,648,769 (31%), outpatient visits $6,552,135 (13%), physical therapy visits $5,723,644 (11%), chiropractic manipulation $1,177,406 (2%), preoperative studies $426,976 (0.8%), medications $263,039 (0.5%), and miscellaneous charges $1,177,371 (2%). Conclusions Charges for preoperative care of patients with lumbar disc herniation are substantial and are split almost evenly between diagnostic charges (outpatient visits, imaging, laboratory studies, and miscellaneous) and therapeutic charges (injections, physical therapy, chiropractic manipulation, and medications). Although a large number of patients will ultimately require surgical intervention, given that many patients will improve with nonoperative therapy, a trial of conservative management is appropriate. Additional studies to identify patients who may ultimately fail nonoperative treatment and would benefit from early discectomy would be beneficial.

Short-term survival advantage after plasma exchange in the treatment of acute on chronic liver failure or acute liver failure

Aim: To investigate the efficacy of plasma exchange (PE) in the treatment of patients with acute on chronic or acute liver failure.Methods: We retrospectively compared the treatment responses of PE and conservative care in patients with acute liver failure from 1998 to 2003. Thirty-two patients treated using supportive care only were enrolled as the control group. The sequential liver biochemical tests, consciousness levels, and survival rates were analyzed.Results: There were no significant differences between the PE and control groups in terms of age, gender, underlying liver disease, grading of hepatic encephalopathy, levels of albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), prothrombin time (PT), activated partial thromboplastin time (aPTT), and total bilirubin. The number of days of survival for the PE group was significantly higher than that of the control group (17.63±1.86 days vs. 8.69±0.86 days, respectively; p<0.05). However, the survival rate was not meaningfully different between the groups (66.7% vs. 59.4%). Transient improvement of hyperbilirubinemia and encephalopathy grade was noted in the PE group compared with the control group.Conclusions: The short-term outcome was better with PE, suggesting perhaps a temporary improvement which would only be of benefit whilst awaiting liver transplantation.