Involving Patients in Their Care Decisions and JAMA Editorial: The New Cholesterol and Blood Pressure Guidelines: Perspective on the Path Forward

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Involving Patients in Their Care Decisions and JAMA Editorial: The New Cholesterol and Blood Pressure Guidelines: Perspective on the Path Forward

Krumholz HM. The New Cholesterol and Blood Pressure Guidelines: Perspective on the Path Forward. JAMA. 2014 Mar 29. doi: 10.1001/jama.2014.2634. [Epub ahead of print] PubMed PMID: 24682222.

http://jama.jamanetwork.com/article.aspx?articleid=1853201

Here is an excellent editorial that highlights the importance of patient decision-making.  We thank the wonderful Dr. Richard Lehman, MA, BM, BCh, Oxford, & Blogger, BMJ Journal Watch, for bringing this to our attention. [Note: Richard’s wonderful weekly review of medical journals—informative, inspiring and oh so droll—is here.]

We have often observed that evidence can be a neutralizing force. This editorial highlights for us that this means involving the patient in a meaningful way and finding ways to support decisions based on patients’ personal requirements. These personal “patient requirements” include health care needs and wants and a recognition of individual circumstances, values and preferences.

To achieve this, we believe that patients should receive the same information as clinicians including what alternatives are available, a quantified assessment of potential benefits and harms of each including the strength of evidence for each and potential consequences of making various choices including things like vitality and cost.

Decisions may differ between patients, and physicians may make incorrect assumption about what most matters to patients of which there are many examples in the literature such as in the citations below.

O’Connor A. Using patient decision aids to promote evidence-based decision making. ACP J Club. 2001 Jul-Aug;135(1):A11-2. PubMed PMID: 11471526.

O’Connor AM, Wennberg JE, Legare F, Llewellyn-Thomas HA,Moulton BW, Sepucha KR, et al. Toward the ‘tipping point’: decision aids and informed patient choice. Health Affairs 2007;26(3):716-25.

Rothwell PM. External validity of randomised controlled trials: “to whom do the results of this trial apply?”. Lancet. 2005 Jan 1-7;365(9453):82-93. PubMed PMID: 15639683.

Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Légaré F, Thomson R. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD001431. Review. PubMed PMID: 21975733.

Wennberg JE, O’Connor AM, Collins ED, Weinstein JN. Extending the P4P agenda, part 1: how Medicare can improve patient decision making and reduce unnecessary care. Health Aff (Millwood). 2007 Nov-Dec;26(6):1564-74. PubMed PMID: 17978377.

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Why Statements About Confidence Intervals Often Result in Confusion Rather Than Confidence

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Why Statements About Confidence Intervals Often Result in Confusion Rather Than Confidence

A recent paper by McCormack reminds us that authors may mislead readers by making unwarranted “all-or-none” statements and that readers should be mindful of this and carefully examine confidence intervals.

When examining results of a valid study, confidence intervals (CIs) provide much more information than p-values. The results are statistically significant if a confidence interval does not touch the line of no difference (zero in the case of measures of outcomes expressed as percentages such as absolute risk reduction and relative risk reduction and 1 in the case of ratios such as relative risk and odds ratios). However, in addition to providing information about statistical significance, confidence intervals also provide a plausible range for possibly true results within a margin of chance (5 percent in the case of a 95% CI). While the actual calculated outcome (i.e., the point estimate) is “the most likely to be true” result within the confidence interval, having this range enables readers to judge, in their opinion, if statistically significant results are clinically meaningful.

However, as McCormack points out, authors frequently do not provide useful interpretation of the confidence intervals, and authors at times report different conclusions from similar data. McCormack presents several cases that illustrate this problem, and this paper is worth reading.

As an illustration, assume two hypothetical studies report very similar results. In the first study of drug A versus drug B, the relative risk for mortality was 0.9, 95% CI (0.80 to 1.05). The authors might state that there was no difference in mortality between the two drugs because the difference is not statistically significant. However, the upper confidence interval is close to the line of no difference and so the confidence interval tells us that it is possible that a difference would have been found if more people were studied, so that statement is misleading. A better statement for the first study would include the confidence intervals and a neutral interpretation of what the results for mortality might mean. Example—

“The relative risk for overall mortality with drug A compared to placebo was 0.9, 95% CI (0.80 to 1.05). The confidence intervals tell us that Drug A may reduce mortality by up to a relative 20% (i.e., the relative risk reduction), but may increase mortality, compared to Drug B, by approximately 5%.”

In a second study with similar populations and interventions, the relative risk for mortality might be 0.93, 95% CI (0.83 to 0.99). In this case, some authors might state, “Drug A reduces mortality.” A better statement for this second hypothetical study would ensure that the reader knows that the upper confidence interval is close to the line of no difference and, therefore, is close to non-significance. Example—

“Although the mortality difference is statistically significant, the confidence interval indicates that the relative risk reduction may be as great as 17% but may be as small as 1%.”

The Bottom Line

  1. Remember that p-values refer only to statistical significance and confidence intervals are needed to evaluate clinical significance.
  2. Watch out for statements containing the words “no difference” in the reporting of study results. A finding of no statistically significant difference may be a product of too few people studied (or insufficient time).
  3. Watch out for statements implying meaningful differences between groups when one of the confidence intervals approaches the line of no difference.
  4. None of this means anything unless the study is valid. Remember that bias tends to favor the intervention under study.

If authors do not provide you with confidence intervals, you may be able to compute them yourself, if they have supplied you with sufficient data, using an online confidence interval calculator. For our favorites, search “confidence intervals” at our web links page: http://www.delfini.org/delfiniWebSources.htm

Reference

McCormack J, Vandermeer B, Allan GM. How confidence intervals become confusion intervals. BMC Med Res Methodol. 2013 Oct 31;13(1):134. [Epub ahead of print] PubMed PMID: 24172248.

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Delfini Treatment Messaging Scripts™ Update

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 Messaging Scripts ™ Update

Delfini Messaging Scripts  are scripts for scripts. Years ago we were asked by a consultancy pharmacy to come up with a method to create concise evidence-based statements for various therapies.  That’s how we came up with our ideas for Messaging Scripts, which are targeted treatment messaging & decision support tools for specific clinical topics. Since working with that group, we created a template and some sample scripts which have been favorably received wherever we have shown them.  The template is available at the link below, along with several samples.  Samples recently updated: Ace Inhibitors, Alendronate, Sciatica (Low Back Pain), Statins (two scripts) and Venous Thromboembolism (VTE) Prevention in Total Hip and Total Knee Replacement.

 http://www.delfini.org/page_SamePage_RxMessagingScripts.htm

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The Elephant is The Evidence—Epidural Steroids

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The Elephant is The Evidence—Epidural Steroids: Edited & Updated 1/7/2013

Epidural steroids are commonly used to treat sciatica (pinched spinal nerve) or low back pain.  As of January 7, 2013 at least 40 deaths have been linked to fungal meningitis thought to be caused by contaminated epidural steroids, and 664 cases in 19 states have been identified with a clinical picture consistent with fungal infection [CDC]. Interim data show that all infected patients received injection with preservative-free methylprednisolone acetate (80mg/ml) prepared by New England Compounding Center, located in Framingham, MA. On October 3, 2012, the compounding center ceased all production and initiated recall of all methylprednisolone acetate and other drug products prepared for intrathecal administration.

Thousands of patients receive epidural steroids without significant side effects or problems every week. In this case, patients received steroids that were mixed by a “compounding pharmacy” and contamination of the medication appears to have occurred during manufacture. But let’s consider other patients who received epidural steroids from uncontaminated vials. How much risk and benefit are there with epidural steroids? The real issue is the effectiveness of epidural steroids. Yes, there are risks with epidural steroids beyond contamination—e.g., a type of headache that occurs when the dura (the sac around the spinal cord) is punctured and fluid leaks out. This causes a pressure change in the central nervous system and a headache. Bleeding is also a risk. But people with severe pain from sciatica are frequently willing to take those risks if there are likely to be benefits. But, in fact, for many patients who receive epidural steroids the likelihood of benefit is very low. For example, patients with bone problems (spinal stenosis) rather than lumbar disc disease are less likely to benefit. Patients who have had a long history of sciatica are less likely to benefit.

We don’t know how many of these patients were not likely to benefit from the epidural steroids, but if the infected patients had been advised about the unproven benefits of epidural steroids in certain cases and the known risks, some patients may have chosen to avoid the injections and possibly be alive today.  This is an example of the importance of good information as the basis for decision-making. Basing decisions on poor quality or incomplete information and intervening with unproven—yet potentially risky treatments puts millions of people at risk every week.

Let’s look at the evidence. Recently, a fairly large, well-conducted RCT published in the British Medical Journal (BMJ) reported that there is no meaningful benefit from epidural steroid injections in patients who have had long term (26 to 57 weeks) of sciatica [Iverson].  As pointed out in an editorial, epidural steroids have been used for more than 50 years to treat low back pain and sciatica and are the most common intervention in pain clinics throughout the world [Cohen]. And yet, despite their widespread use, their efficacy for the treatment of chronic sciatica remains unproven. (We should add here that many times lacking good evidence of benefit does not mean a treatment does not work.) Iverson et al conclude that, “Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy [Iverson].”

Of more than 30 controlled studies evaluating epidural steroid injections, approximately half report some benefit. Systematic reviews also report conflicting results. Reasons for these discrepancies include differences in study quality, treatments, comparisons, co-interventions, study duration and patient selection. Results appear to be better for people with short term sciatica, but improvement should not be considered to be curative with epidural steroids. In this situation, it is very important that patients understand this fuzzy benefit-to-risk ratio. For many who are completely informed, the decision will be to avoid the risk.

With this recent problem of fungal meningitis from epidural steroids, it is important for patients to be informed about the world of uncertainty that surrounds risk, especially when science tells us that the evidence for benefit is not strong.  Since health care professionals frequently act as the eyes of the patient, we must seriously consider for every intervention we offer whether benefits clearly outweigh potential harms—and we must help patients understand details regarding the risks and benefits and be supportive when patients are “on the fence” about having a procedure. Remember Vioxx, arthroscopic lavage, vertebroplasy, encainide and flecainide, Darvon and countless other promising new drugs and other interventions? They seemed promising, but harms outweighed benefits for many patients.

References

1. http://www.cdc.gov/HAI/outbreaks/meningitis.html accessed 12/10/12

2.  Cohen SP. Epidural steroid injections for low back pain. BMJ. 2011 Sep 13;343:d5310. doi: 10.1136/bmj.d5310. PubMed PMID: 21914757.

3.  Iversen T, Solberg TK, Romner B, et al.   Effect of caudal epidural steroid or saline injection  in chronic lumbar radiculopathy: multicentre, blinded, randomised controlled trial. BMJ. 2011 Sep 13;343:d5278. doi: 10.1136/bmj.d5278. PubMed PMID: 21914755.

 

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Divulging Information to Patients With Poor Prognoses

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Divulging Information to Patients With Poor Prognoses

We have seen several instances where our colleagues’ families have been given very little prognostic information by their physicians in situations where important decisions involving benefits versus harms, quality of life and other end of life decisions must be made. In both cases when a clinician in the family presented the evidence and prognostic information, decisions were altered.

We were happy to see a review of this topic by Mack and Smith in a recent issue of the BMJ.[1] In a nutshell the authors point out that—

  • Evidence consistently shows that healthcare professionals are hesitant to divulge prognostic information due to several underlying misconceptions. Examples of misconceptions—
    • Prognostic information will make patients depressed
    • It will take away hope
    • We can’t be sure of the patient’s prognosis anyway
    • Discussions about prognosis are uncomfortable
  • Many patients are denied discussion about code status, advance medical directives, or even hospice until there are no more treatments to give  and little time left for the patient
  • Many patients lose important  time with their families and and spend more time in the hospital and in intensive care units than would be if prognostic information had been provided and different decisions had been made.

Patients and families want prognostic information which is required to make decisions that are right for them. This together with the lack of evidence that discussing prognosis causes depression, shortens life, or takes away hope and the huge problem of unnecessary interventions at the end of life creates a strong argument for honest communication about poor prognoses.

Reference

1. Mack JW, Smith TJ. Reasons why physicians do not have discussions about poor prognosis, why it matters, and what can be improved. J Clin Oncol. 2012 Aug 1;30(22):2715-7. Epub 2012 Jul 2. PubMed PMID: 22753911.

 

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Update on Decision Support for Clinicians and Patients

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Update on Decision Support for Clinicians and Patients

We have written extensively and provide many examples of decision support materials on our website. An easy way to round them up is to go to our website search window http://www.delfini.org/index_SiteGoogleSearch.htm and type in the terms “decision support.”

A nice systematic review of the topic funded by AHRQ—Clinical Decision Support Systems (CDSSs)— has recently been published in the Annals of Internal Medicine.[1]  The aim of the review was to evaluate the effect of CDSSs on clinical outcomes, health care processes, workload and efficiency, patient satisfaction, cost, and provider use and implementation. CDSSs include alerts, reminders, order sets, drug-dose information, care summary dashboards that provide performance feedback on quality indicators, and information and other aids designed to improve clinical decision-making.

Findings:  148 randomized controlled trials were included in the review. A total of 128 (86%) assessed health care process measures, 29 (20%) assessed clinical outcomes, and 22 (15%) measured costs. Both commercially and locally developed CDSSs improved health care process measures related to performing preventive services (n =25; odds ratio [OR] 1.42, 95% CI [1.27 to 1.58]), ordering clinical studies (n=20; OR 1.72, 95% CI [1.47 to 2.00]), and prescribing therapies (n=46; OR 1.57, 95% CI [1.35 to 1.82]). There was heterogeneity in interventions, populations, settings and outcomes as would be expected. The authors conclude that commercially and locally developed CDSSs are effective at improving health care process measures across diverse settings, but evidence for clinical, economic, workload and efficiency outcomes remains sparse.

Delfini Comment: Although this review focused on decision support systems, the entire realm of decision support for end users is of great importance to all health care decision-makers. Without good decision support, we will all make suboptimal decisions. This area is huge and is worth spending time understanding how to move evidence from a synthesis to decision support. Interested readers might want to look at some examples of wonderful decision support materials created at the Mayo Clinic. The URL is—

http://webpages.charter.net/vmontori/Wiser_Choices_Program_Aids_Site/Welcome.html

Reference

1.  Bright TJ, Wong A, Dhurjati R, Bristow E, Bastian L, Coeytaux RR, Samsa G, Hasselblad V, Williams JW, Musty MD, Wing L, Kendrick AS, Sanders GD, Lobach D. Effect of clinical decision-support systems: a systematic review. Ann Intern Med. 2012 Jul 3;157(1):29-43. PubMed PMID: 22751758.

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Why People Tend to Overuse Healthcare Interventions

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Why People Tend to Overuse Healthcare Interventions

This nice piece in Time Magazine by Maia Szalavitz provides some clues about our major problem of overuse. Ms. Szalavitz documents the convincing power of anecdotes compared to statistics which are poorly understood by most people. She provides a really nice example of decision support from the Harding Center for Risk Literacy for prostate cancer screening that illustrates graphically how prostate cancer screening is likely to create more harms than benefits.  For more information go to—

http://healthland.time.com/2012/05/25/why-people-cling-to-cancer-screening-and-other-questionable-medical-interventions-even-when-they-cause-harm/

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Appendicitis 1889 to 2012: What, No Surgery?

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Appendicitis 1889 to 2012: What, No Surgery?

All medical students learn about McBurney’s point—that’s the spot, named for McBurney, in the right lower quadrant of the abdomen where classical appendicitis pain finally localizes.[1] If the patient’s history fits the classic history of appendicitis with vague abdominal pain eventually localizing to McBurney’s point, the norm has been—at least in the U.S. —to take the appendix out. However, as pointed out in a new systematic review done as a meta-analysis, starting in the late 1950s there were reports of success in treating appendicitis with conservative therapy (antibiotics) and good outcomes without resorting to appendectomy.[2]

This systematic review presents a review of our traditions and lack of conclusive evidence about best practices in managing appendicitis and suggests that, for many patients, avoiding appendectomy may be a reasonable option. The current meta-analysis of four selected randomized controlled trials from 59 eligible trials with a total of 900 patients, reported a relative risk reduction for complications (perforation, peritonitis, wound infection) from appendicitis of 31% for antibiotic treatment compared with appendectomy (risk ratio 0.69 (95% confidence interval 0.54 to 0.89); I2=0%; P=0.004). There were no significant differences between antibiotic treatment and appendectomy for length of hospital stay, efficacy of treatment, or risk of complicated appendicitis.

The biggest problem in this meta-analysis is that the results are based on trials with significant threats to validity. Randomization sequence was computer generated in one trial, by “external randomization” in one trial, by date of birth in one trial and unclear in one trial. Concealment of allocation was by sealed envelopes in two trials and not reported in the other two trials. All trials were unblinded. Withdrawal rates are unclear. Therefore, it is uncertain how much the results of this meta-analysis may have been distorted by bias. In addition, as pointed out by an editorialist, in patients who have persistent problems despite antibiotic treatment, delayed appendectomy might be necessary.[3] Delayed appendectomy has been associated with a high complication rate. Also, if a patient develops an inflammatory phlegmon—a palpable mass at clinical examination or an inflammatory mass or abscess at imaging or at surgical exploration—appendectomy sometimes has to be converted to an ileocecal resection—a much more involved operation. Another important issue with antibiotic treatment is the chance of recurrence. The current meta-analysis found a 20% chance of recurrence of appendicitis after conservative treatment within one year. Of the recurrences, 20% of patients presented with a perforated or gangrenous appendicitis. The editorialist questions whether a failure rate of 20% within one year is acceptable.

These four trials and this meta-analysis suggest that antibiotics may be safe for some patients with uncomplicated appendicitis. If this option is considered, we believe detailed information about the uncertainties regarding benefits and risks should be made known to patients. Details are available at http://www.bmj.com/content/344/bmj.e2156

References

1. Thomas CG Jr. Experiences with Early Operative Interference in Cases of Disease of the Vermiform Appendix by Charles McBurney, M.D., Visiting Surgeon to the Roosevelt Hospital, New York City. Rev Surg. 1969 May-Jun;26(3):153-66. PubMed PMID: 4893208.

2. Varadhan KK, Neal KR, Lobo DN. Safety and efficacy of antibiotics compared with appendicectomy for treatment of uncomplicated acute appendicitis: meta-analysis of randomised controlled trials. BMJ. 2012 Apr 5;344:e2156. doi: 10.1136/bmj.e2156. PubMed PMID: 22491789.

3. BMJ 2012;344:e2546 (Published 5 April 2012).

 

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Three Questions Patients Should Ask To Improve the Information They Receive

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Three Questions Patients Should Ask To Improve the Information They Receive

According to Shepherd  et al [1], the following questions appear to be powerful catalysts for good information exchanges between clinicians and patients:

1. “What are my options?”

2. “What are the benefits and harms of each?”

3. “How likely are the benefits and harms?”

Let’s start with Shepherd’s cross-over trial using the three questions above.[1]  In order to make informed decisions and improve outcomes, patients need reliable information about benefits and risks of the various options.  In this randomized cross-over trial, Shepherd et al. used two standardized patients with identical symptoms— one patient asked the three questions (and also about doing nothing if the physician did not mention this option), the other did not. The patient presented as an otherwise healthy divorced middle-aged female with one prior undiagnosed episode of depression and 3 months of worsening moderate symptoms of depression. Depression was chosen as the condition because evidence is available and patients express differences in preference for treatment. The authors found that the 3 questions were associated with greater provision of information and behavior supporting patient involvement without extending appointment time.

Stiggelbout et al. remind us that shared decision-making (SDM) should be routinely employed to ensure patient autonomy, beneficence (balancing risks and benefits), non-malfeasance (avoiding harm) and justice (patients frequently decline procedures when adequate information has been provided and this may result in improved sharing of limited resources).[2] Pamphlets, videos, tools of various sorts may be employed to facilitate SDM. Tactics and tools that appear to increase SDM include—

  • Creating awareness of equipoise (there is no best choice but a decision must be made—even if it is to do nothing);
  • Presenting or encouraging patients to ask about options and benefits and risks of each option;
  • Use of graphical displays to present risks;
  • Use absolute risk information such as the number of similar patients/100 or number/1000 who will benefit*;
  • Encouraging patients to pay attention to their preferences;
  • Provide appropriate support to help patients make decisions—respect the patient’s preference about his or her role—independent, shared or delegated decision-making role.

*We would add that this information is only useful when also providing information  that provides a more complete picture.  To hear that one’s chance of benefiting from an intervention is 5 out of a hundred has a very different meaning depending upon the specific context:

  • Scenario 1: Out of 100 patients, 10 taking drug A improved as compared to 5 taking placebo, versus—
  • Scenario 2: Out of 100 patients, 90 taking drug A improved as compared to 95 taking placebo.

Examples of decision-aids are available from the following: http://shareddecisions.mayoclinic.org.

Delfini Comment: “Patient demand,”  i.e., activating patients to voice their information needs, has been proposed as a method of improving healthcare consultations for several decades. In our experience, educational programs aimed at increasing the use of  evidence-based information sharing with patients has been hampered by clinicians frequently not possessing accurate answers to the three questions studied here. The two studies discussed above [3,4] indicate  that patient-mediated approaches may be at least part of the answer to improved clinical decision-making.

References

1. Shepherd HL et al. Three questions that patients can ask to improve the quality of information physicians give about treatment options: a cross-over trial. Patient Educ Couns. 2011 Sep;84(3):379-85. Epub 2011 Aug 9.PubMed PMID: 21831558.

2. Stiggelbout AM et al.  Shared decision making: really putting patients at the centre of healthcare. BMJ. 2012 Jan 27;344:e256. doi: 10.1136/bmj.e256. PubMed PMID:22286508.

3. Bell RA et al. Encouraging patients with depressive symptoms to seek care: a mixed methods approach to message development. Patient Educ Couns. 2010 Feb;78(2):198-205. Epub 2009 Aug 11. PubMed PMID: 19674862.

4. Kravitz RL et al. Influence of patients’ requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA. 2005 Apr 27;293(16):1995-2002. Erratum in: JAMA. 2005 Nov 16;294(19):2436. PubMed PMID: 15855433; PubMed Central PMCID: PMC3155410.

 

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GLIDE Patient Encounter Map

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GLIDE Patient Encounter Map

It isn’t something new, but as a recent patient, I was reminded of our Patient Encounter Map tool. Most people know us for our work in medical science, but our reach is the expanse of clinical care improvement, and effective communications with patients is of the utmost importance in caring for them. Our GLIDE strategy was promoted by the late and wonderful Dr. John Coombs of the University of Washington as an effective way to help patients: Greet . Listen . Inquire and Exchange Information . Determine and Decide . Effectively End. Happy Holidays, all!

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