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"Montori, G."
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Nationwide analysis of open groin hernia repairs in Italy from 2015 to 2020
2023
Introduction
Inguinal hernia repair is one of the most commonly performed operations in general surgery. A total of 130.000 inguinal hernia repairs are performed yearly in Italy, and approximately 20 million inguinal hernias are treated worldwide annually. This report represents the trend analysis in inguinal hernia repair in Italy from a nationwide dataset for the 6-year period from 2015 to 2020.
Materials and methods
Based on regional hospital discharge records, all the inguinal hernia repairs performed in public and private hospitals in Italy between 2015 and 2020 were reviewed based on diagnosis and procedure codes. For the aim of this study, data from the AgeNas (The National Agency for Regional Health Services) data source were analyzed.
Results
Elective inguinal hernia repairs outnumbered urgent operations over the 6-year study period, ranging from 122,737 operations in 2015 to 65,780 in 2020 as absolute numbers, and from 87.96 to 83.3% of total procedures in 2019 and 2020 respectively, with an annual change ranging from − 66.58%, between 2020 and 2019, to − 2.49%, between 2019 and 2018 (mean = − 18.74%; CI =− 46.7%–9.22%; p < 0.0001).
Conclusions
This large-scale review of groin hernia data from a nationwide Italian dataset provides a unique opportunity to obtain a snapshot of open groin hernia repair activity. More specifically, there is a trend to perform more elective than urgent procedures and there is a steady decrease in the amount of open hernia repairs in favor to laparoscopy.
Journal Article
Acute Appendicitis: Still a Surgical Disease? Results from a Propensity Score-Based Outcome Analysis of Conservative Versus Surgical Management from a Prospective Database
2017
Objective
The aim of the present study was to compare the outcomes of conservative versus surgical treatment for acute appendicitis.
Background
Although acute appendicitis is a common disease, great debate exists regarding the appropriate management of patients. Conservative treatment has shown positive results in several RCTs, eliciting questions about indications to surgery, therapeutic appropriateness and ethical conduct.
Methods
Data were prospectively collected; a Propensity Score-based matching method was implemented in order to reduce bias arising from characteristics of the patients; a proportion of patients (69 in total) were excluded to obtain two comparable groups of study (1a). Main outcomes of the study were: failure rate, in-hospital length of stay (at first admission and cumulative), post-discharge absence from work. Within the medical group, failure was defined as the necessity for appendectomy after conservative treatment, while it was identified with complications and negative appendectomy within the surgical group (Failure 1). In parallel, an additional definition of failure was proposed (Failure 2) and excluded negative appendectomy from the reasons for failure within the surgical group (5b).
Results
The failure rate for the conservative treatment resulted to be inferior, as compared to the surgical treatment (16.5 vs. 28.4%, OR 0.523
p
= 0.019), considering negative appendectomy as a reason for failure. When excluding negative appendectomy from the definition of failure, medical and surgical treatment appeared to perform equally (failure rate: 16.5 vs. 18.3%, OR 1.014
p
= 0.965). Patients managed conservatively showed to have a shorter length of stay at first admission than the patients who underwent appendectomy (3.11 vs. 4.11 days,
β
= −0.628 days,
p
< 0.0001). A lower number of lost work days after discharge resulted from a conservative approach (6 vs. 14.64 days,
β
= −8.7 days,
p
< 0.0001).
Conclusions
Considering each outcome as part of a wide-angle analysis, the conservative management of acute appendicitis resulted to be safe and effective in the selected group of patients. In terms of failure rate, the medical treatment resulted to perform as effectively as surgical treatment, if negative appendectomy was excluded from failure, or better, when negative appendectomy was included in the definition of failure. A diminished length of stay during the first admission and a reduced number of lost work days were evident with a conservative approach. The comparison between medical and surgical treatment for acute appendicitis requires a change in perspective, from a spare ‘effectiveness analysis’ to a more thorough ‘appropriateness analysis’: in the present study, the conservative treatment showed to address the clinical requirements in terms of therapeutic appropriateness. Although acute appendicitis is considered a ‘surgical disease’, increasing evidence supports the effectiveness and safety of a conservative approach for selected groups of patients.
Journal Article
Laparoscopic lavage versus resection in perforated diverticulitis with purulent peritonitis: a meta-analysis of randomized controlled trials
by
Ansaloni, Luca
,
Catena, Fausto
,
Ceresoli, Marco
in
Analysis
,
Care and treatment
,
Complications and side effects
2016
Objective
Purulent peritonitis from acute left colon diverticulitis is a relatively common presentation of diverticular disease; historically the treatment was the Hartmann procedure. Laparoscopic peritoneal lavage has been proposed as a lesser invasive treatment option with great interest and debate among surgeons and with contrasting results. The aim of this meta-analysis was to compare the results of sigmoid resection with laparoscopic lavage.
Methods
A systematic review was performed to select randomized controlled trials comparing laparoscopic lavage versus resection in Hinchey III diverticulitis. Studies’ selection, data extraction and risk of bias assessment were done by two independent authors; results were shown as OR with 95 % C.I.
Results
Three RCT were selected for the meta-analysis including 315 patents. Laparoscopic lavage was associated with significantly more reoperations (OR 3.75,
p
= 0.006) and more intra-abdominal abscesses (OR 3.50,
p
= 0.0003) with no differences in mortality (OR 0.93,
p
= 0.92). At 12 months follow up laparoscopic lavage was associated with lesser reoperations (OR 0.32,
p
= 0.0004); there were no differences in term of stoma presence (OR 0.44
p
= 0.27) and mortality (OR 0.74
p
= 0.51).
Conclusions
The present meta-analysis shows that in acute perforated diverticulitis with purulent peritonitis laparoscopic lavage is comparable to sigmoid resection in term of mortality but it is associated with a significantly higher rate of reoperations and a higher rate of intra-abdominal abscess. No differences in term of mortality were demonstrated at follow-up. Further studies are needed to better define the safety and appropriateness of this treatment.
Journal Article
Guidelines should consider clinicians’ time needed to treat
2023
Minna Johansson, Gordon Guyatt, and Victor Montori argue that assessing the implementation time of guidelines would help make best use of clinical resources
Journal Article
CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
by
Moher, David
,
Hopewell, Sally
,
Egger, Matthias
in
Bias
,
Clinical trials
,
Clinical Trials (Epidemiology)
2010
[...]random assignment permits the use of probability theory to express the likelihood that any difference in outcome between intervention groups merely reflects chance. 26 Third, random allocation, in some situations, facilitates blinding the identity of treatments to the investigators, participants, and evaluators, possibly by use of a placebo, which reduces bias after assignment of treatments. 27 Of these three advantages, reducing selection bias at trial entry is usually the most important. 28 Successful randomisation in practice depends on two interrelated aspects-adequate generation of an unpredictable allocation sequence and concealment of that sequence until assignment occurs. 2 23 A key issue is whether the schedule is known or predictable by the people involved in allocating participants to the comparison groups. 29 The treatment allocation system should thus be set up so that the person enrolling participants does not know in advance which treatment the next person will get, a process termed allocation concealment. 2 23 Proper allocation concealment shields knowledge of forthcoming assignments, whereas proper random sequences prevent correct anticipation of future assignments based on knowledge of past assignments. [...]assessments will likely improve the clarity and transparency of published trials. Because CONSORT is an evolving document, it requires a dynamic process of continual assessment, refinement, and, if necessary, change, which is why we have this update of the checklist and explanatory article.
Journal Article
Shared decision-making as a method of care
by
Montori, Victor M
,
Kunneman, Marleen
,
Ruissen, Merel M
in
Cancer
,
Clinical Decision-Making
,
Collaboration
2023
Care happens in interaction between the patient and the clinician, in conversation where the patient and clinician uncover or develop a shared understanding of the problematic situation of the patient and identify, discover, or invent ways to make that situation better, given what each patient prioritises and seeks.1 Thus, to get the right care for each patient, patient and clinician collaborate and deliberate together to figure out what to do.2 Shared decision-making (SDM) has been traditionally defined as a collaborative approach by which, in partnership with their clinician, patients are encouraged to think about the available care options and the likely benefits and harms of each, to communicate their preferences, and help select the best course of action that fits these.3 This definition is limited to situations in which the problem and the pertinent options to address it can be defined a priori, and the main task is to find the option that best matches the patient’s preferences. The practical method to implement SDM as a method of care proposed below seeks to make as few demands as possible of both patients, who are taxed by the demands of self-care and of navigating a labyrinthine healthcare system while responding to the demands of living,8 and of clinicians, who, despite some evidence of the contrary,9 often express their worries about SDM adding time to their encounters.10 Practicing SDM as a method of care Here, we propose a simple method to implement SDM in practice (see summary box 1).Box 1 Steps for shared decision-making (SDM) in practice (1) Foster a conversation Key elements: problem definition, iteration, co-creation (2) Purposefully select and adapt the SDM process Matching preferences Reconciling conflicts Problem-solving Meaning making (3) Support SDM Protect the space Make the most of participation Deploy useful tools Advocate for care (4) Evaluate and learn SDM Evaluate beyond outcomes Share the evaluation Seek joint improvement Foster a conversation The first step in implementing SDM in practice is to foster conversations that invite patients and clinicians to collaborate, supports their collaboration and leads to the formulation of a codeveloped care plan. When made prematurely, a clinician’s recommendation or a patient’s demand can abort the exploration for new insights; when unacceptable to the other party, these can complicate the patient–clinician relationship.14 Also, a desire to avoid conflict may lead to either party acquiescing, which is why policies (eg, guidelines, pathways, formulary restrictions, preauthorisations) and marketing campaigns (eg, detailing to clinicians, direct-to-consumer advertising and ‘ask your doctor about…’ ads) can unduly shape care.15 16 Purposefully select and adapt the SDM process There are four distinct ways in which patients and clinicians can work together to address the patient’s problematic situation: (A) focusing on matching preferences, (B) reconciling conflicts, (C) problem-solving or (D) meaning making.4 Each of these forms of SDM is best suited to address one of four different kinds of problematic situations (tables 1 and 2). Clinicians need to be aware of these forms of SDM to intentionally select the form best suitable to respond to the situation at hand, avoid selecting the wrong one and nimbly switching to a different form when the situation becomes clearer or changes.17 In our observations, clinicians and patients who do SDM well, work within a form of SDM until a better one becomes apparent and they flexibly, gracefully and perhaps intuitively switch according to the challenges uncovered during the conversation.17 For example, a conflict requiring reconciliation (‘I will never use insulin because I am not allowed to use needles at my job’) can become a problem requiring solving (‘Is there a way to use insulin such that it is only administer at home?’).Table 1 Forms of shared decision-making (SDM) SDM form method description Situations in which this form will be preferred Matching preferences Patients and clinicians compare features (ie, efficacy, burdens, side effects) of the available options and match them with the patient’s values, preferences, goals, and priorities.
Journal Article
Uncovering Treatment Burden as a Key Concept for Stroke Care: A Systematic Review of Qualitative Research
by
Erwin, Patricia J.
,
Mair, Frances S.
,
Jani, Bhautesh
in
Brain research
,
Care and treatment
,
Chronic illnesses
2013
Patients with chronic disease may experience complicated management plans requiring significant personal investment. This has been termed 'treatment burden' and has been associated with unfavourable outcomes. The aim of this systematic review is to examine the qualitative literature on treatment burden in stroke from the patient perspective.
The search strategy centred on: stroke, treatment burden, patient experience, and qualitative methods. We searched: Scopus, CINAHL, Embase, Medline, and PsycINFO. We tracked references, footnotes, and citations. Restrictions included: English language, date of publication January 2000 until February 2013. Two reviewers independently carried out the following: paper screening, data extraction, and data analysis. Data were analysed using framework synthesis, as informed by Normalization Process Theory. Sixty-nine papers were included. Treatment burden includes: (1) making sense of stroke management and planning care, (2) interacting with others, (3) enacting management strategies, and (4) reflecting on management. Health care is fragmented, with poor communication between patient and health care providers. Patients report inadequate information provision. Inpatient care is unsatisfactory, with a perceived lack of empathy from professionals and a shortage of stimulating activities on the ward. Discharge services are poorly coordinated, and accessing health and social care in the community is difficult. The study has potential limitations because it was restricted to studies published in English only and data from low-income countries were scarce.
Stroke management is extremely demanding for patients, and treatment burden is influenced by micro and macro organisation of health services. Knowledge deficits mean patients are ill equipped to organise their care and develop coping strategies, making adherence less likely. There is a need to transform the approach to care provision so that services are configured to prioritise patient needs rather than those of health care systems.
Journal Article