A systematic review and meta-analysis on partial foot amputation in diabetic foot ulcers.

Category: Ankle, Diabetes, Lesser Toes, Midfoot/Forefoot Introduction/Purpose: Maximal limb preservation is often the goal in choosing partial foot amputation (PFA) as a treat-ment for diabetic foot infections. Some of these patients will go on to experience multiple hospital admissions, IV antibiotic courses, surgical debridements, re-amputations and other medical compli-cations. This study describes the treatment course of these patients starting at second partial foot amputation and ending at 5 year follow-up. Methods: A retrospective cohort was built from a database of all amputation procedures performed on diabet-ic patients at the University of Iowa Department of Orthopedics from 2000 – 2015. The cohort was evaluated over time frame starting at second PFA (index procedure) and ending at 5 years after in-dex procedure. Of 264 patients who underwent partial foot amputation, 49 experienced two lower extremities PFA between January 2000 and December 2011 (cut-off used to allow minimum of 5 years post-PFA). Demographic data was recorded at index PFA and included surgical dates, laterali-ty, surgery type, diagnoses at time of initial surgery, and death date. A chart review collected in-formation on 5 year post-index PFA incidence of: non-surgical hospitalizations, antibiotic admin-istrations, total contact cast applications, and complications (such as osteomyelitis and acute renal failure). Results: Thirty-two (65%) of the second partial foot amputations (index) were ipsilateral and 17 were con-tralateral to first partial foot amputation (pre-index procedure). Eighteen (37%) of the partial foot amputation patients eventually experienced transtibial / transfemoral amputations in the 5 years fol-lowing index PFA. Eleven (22%) had at least a third partial foot amputation (and as many as 7) dur-ing study period. Sixteen (32%) patients had 17 transtibial / transfemoral amputations within 5 year time frame. 11 of the 17 (65%) TT / TF procedures were ipsilateral to index (second) PFA. Seven (17%) of the patients died. Conclusion: Maximal limb preservation may not be beneficial in all cases, particularly in the case of repeat PFAs. This cohort of repeat PFA patients demonstrated a complicated medical course with long pe-riods of hospitalization, leg immobilization in cast, and home-going antibiotics (requiring PICC). This study suggested that over a 5 year period following second PFA, patients on average experi-enced at least 31 days in TCC, 17 days hospitalized and underwent one additional amputation pro-cedure. These are likely underestimates due to follow-up or outside hospital cares. A large number of patients (18 or 37%) ultimately required higher-level amputation. There is a potential morbidity with PFA that may not be communicated to patients when making these decisions. In this cohort, the average days to second PFA was 360 days. 18 of 49 repeat PFA patients underwent tran-stibial or transfemoral amputation within 5 years of their initial PFA. The morbidity of the interim medical course over 5 years added to the poor quality of life after PFA.

Difficulties in recruiting subjects with partial foot amputations for kinesiological research

Summary and Conclusions From the Academy's Eighth State-of-the-Science Conference, on the Biomechanics of Ambulation After Partial Foot Amputation

Introduction: The Risk Of Bias in Non-randomized Studies – of Interventions (ROBINS-I) tool evaluates internal validity (risk of bias) in non-randomized studies of interventions in comparison to an ideal (hypothetical) randomized trial. The use of ROBINS-I in studies dealing with exposures or interventions in environmental health has not yet been explored. This study evaluated the usability and applicability of ROBINS-I in studies of environmental health (EH) exposure. Methods: Three researchers in sequential rounds applied ROBINS-I to three systematic reviews of EH exposures: bisphenol-A and obesity; perfluorooctanoic acid and birth weight; and polybrominated diphenyl ethers and thyroid function. We began by providing instructions for application of ROBINS-I to EH studies, including possible confounders and co-exposures specific to the exposures considered in the three reviews. For the first two rounds of testing, two reviewers independently applied ROBINS-I and provided feedback on usability of the tool. Barriers and facilitators to the appropriateness of ROBINS-I for environmental health were identified and modifications made to the tool, as necessary. For the third round of testing, three reviewers independently applied the tool and came to consensus on item-level and overall study risk of bias. Results: Suggested modifications ranged from syntax and wording to conceptual changes to the tool. The term "intervention" was replaced with "exposure" throughout the document. Additional instructions were provided to address assessment of cross-sectional studies. Fields to collect information on measurement of exposures and outcomes of interest was added to the project protocol. Additional granularity was added to the measurement of interventions/exposure domain. Conclusion: Modifications made to the risk of bias tool to tailor it to studies of EH exposure increased understanding and application of the tool, as well as consistency in responses.

BackgroundDysvascular partial foot amputation (PFA) is a common sequel to advanced peripheral vascular disease. Helping inform difficult discussions between patients and practitioners about the level of PFA, or the decision to have a transtibial amputation (TTA) as an alternative, requires an understanding of the current research evidence on a wide range of topics including wound healing, reamputation, quality of life, mobility, functional ability, participation, pain and psychosocial outcomes, and mortality. The aim of this review was to describe a comprehensive range of outcomes of dysvascular PFA and compare these between levels of PFA and TTA.MethodsThe review protocol was registered in PROSPERO (CRD42015029186). A systematic search of the literature was conducted using MEDLINE, EMBASE, psychINFO, AMED, CINAHL, ProQuest Nursing and Allied Health, and Web of Science. These databases were searched using MeSH terms and keywords relating to different amputation levels and outcomes of interest. Peer reviewed studies of original research—irrespective of the study design—were included if published in English between 1 January 2000, and 31 December 2015, and included discrete cohort(s) with dysvascular PFA or PFA and TTA. Outcomes of interest were rate of wound healing and complications, rate of ipsilateral reamputation, quality of life, functional ability, mobility, pain (i.e., residual limb or phantom pain), psychosocial outcomes (i.e., depression, anxiety, body image and self-esteem), participation, and mortality rate. Included studies were independently appraised by two reviewers. The McMaster Critical Review Forms were used to assess methodological quality and identify sources of bias. Data were extracted based on the Cochrane Consumers and Communication Review Group’s data extraction template by a primary reviewer and checked for accuracy and clarity by a second reviewer. Findings are reported as narrative summaries given the heterogeneity of the literature, except for mortality and ipsilateral reamputation where data allowed for proportional meta-analyses.ResultsTwenty-nine unique articles were included in the review, acknowledging that some studies reported multiple outcomes. Eighteen studies reported all-cause proportionate mortality. A smaller number of studies reported outcomes related to functional ability (two), mobility (four), quality of life (three), ipsilateral reamputation (six) as well as wound healing and complications (four). No studies related to pain, participation or psychosocial outcomes met the inclusion criteria. Subjects were typically older and male and had diabetes among other comorbidities. More detailed information about the cohorts such as race or sociodemographic factors were reported in an ad hoc manner. Common sources of bias included contamination, co-intervention, or lack of operational definition for some outcomes (e.g., wound healing) as illustrative examples.ConclusionsAside from mortality, there was limited evidence regarding outcomes of dysvascular PFA, particularly how outcomes differ between levels of PFA and TTA. Acknowledging that there is considerable uncertainty given the small body of literature on many topics where the risk of bias is high, the available evidence suggests that a large proportion of people with PFA experience delayed wound healing and ipsilateral reamputation. People with TTA have increased risk of mortality compared to those with PFA, which may reflect that those considered suitable candidates for TTA have more advanced systemic disease that also increases the risk of dying. Mobility and quality of life may be similar in people with PFA and TTA.Systematic review registrationCRD42015029186

Partial foot amputations (PFAs) are often indicated for the treatment of severe infection, osteomyelitis, and critical limb ischemia, which consequently leads to irreversible necrosis. Many patients who undergo PFAs have concomitant comorbidities and generally present with a severe acute manifestation of the condition, such as gangrenous changes, systemic infection, or debilitating pain, which would then require emergency amputation on an inpatient basis. The purpose of this study was to track the recent prevalence of PFAs and to investigate the current demographic trends of the physicians managing and performing PFAs, specifically regarding medical degree and specialty. Doctors of podiatric medicine are striving to achieve parity with their allopathic and osteopathic surgical counterparts and become a more prominent part of the multidisciplinary approach to limb salvage and emergency surgical treatment. This study evaluated 4 years (2009-2012) of PFA data from the Pennsylvania state inpatient database in the two most populated areas of Pennsylvania: Philadelphia and Allegheny counties. Statistics on medical schools were obtained directly from the accrediting bodies of allopathic, osteopathic, and podiatric medical schools. The goal of this study was to evaluate the general trends of patients undergoing a PFA and to quantify the upswing of podiatric surgeons intervening in the surgical care of these patients. The number of partial foot amputations in the United States rose from 2006 to 2012. Podiatric surgeons performed 46% of theses procedures for residents of Philadelphia County from 2009 to 2012. In Allegheny County podiatric physicians performed 42% of these procedures during the same time frame. Partial foot amputations are increasing over time. Podiatric Surgeons perform a significant share of these operations. This share is increasing in the most populated areas of Pennsylvania.

The surgical decision for limb-salvage with free tissue transfer (FTT), partial foot amputation (PFA), or below-knee amputation (BKA) for complex lower extremity (LE) wounds hinges on several factors, including patient choice and baseline function. However, patient-reported outcome measures (PROMs) on LE function, pain, and QoL for chronic LE wound interventions are limited. Thus, the study aim was to compare PROMs in patients who underwent FTT, PFA, or BKA for chronic LE wounds. PROMs were collected via QR code for all adult chronic LE wound patients who presented to a tertiary wound center between June 2022 and June 2023. A cross-sectional analysis of patients who underwent FTT, PFA, or BKA was conducted. The 12-Item Short Survey (SF-12), PROM Information System Pain Intensity (PROMIS-3a), and Lower Extremity Functional Scale (LEFS) were completed at 1, 3, and 6 months and 1, 3, and 5 years postoperatively. Patient demographics, comorbidities, preoperative characteristics, and amputation details were collected. Of 200 survey sets, 71 (35.5%) underwent FTT, 51 (25.5%) underwent PFA, and 78 (39.0%) underwent BKA. Median postoperative time points of survey completion between FTT (6.2 months, IQR: 23.1), PFA (6.8 months, IQR: 15.5), and BKA (11.1 months, IQR: 21.3) patients were comparable (P = 0.8672). Most patients were male (n = 92, 76.0%) with an average age and body mass index (BMI) of 61.8 ± 12.6 years and 30.3 ± 7.0 kg/m2, respectively. Comorbidities for FTT, PFA, and BKA patients included diabetes mellitus (DM; 60.6% vs 84.2% vs 69.2%; P = 0.165), peripheral vascular disease (PVD; 48.5% vs 47.4% vs 42.3%; P = 0.790), and chronic kidney disease (CKD; 12.1% vs 42.1% vs 30.8%; P = 0.084). No significant differences were observed between FTT, PFA, and BKA patients in mean overall PROMIS-3a T-scores (49.6 ± 14.8 vs 54.2 ± 11.8 vs 49.6 ± 13.7; P = 0.098), LEFS scores (37.5 ± 18.0 vs 34.6 ± 18.3 vs 38.5 ± 19.4; P = 0.457), or SF-12 scores (29.6 ± 4.1 vs 29.5 ± 2.9 vs 29.0 ± 4.0; P = 0.298). Patients receiving FTT, PFA, or BKA for chronic LE wounds achieve comparable levels of LE function, pain, and QoL postoperatively. Patient-centered functionally based surgical management for chronic LE wounds using interdisciplinary care, preoperative medical optimization, and proper patient selection optimizes postoperative PROMs.

Introduction The European Association of Urology guidelines recommend offering kidney-sparing surgery (KSS) as a primary treatment option to patients with low-risk tumours. Cystoscopy, urinary cytology, and computed tomography urography (CTU) do not always allow correct disease staging and grading, and sometimes there is even a lack of certainty regarding the diagnosis of UTUC. Diagnostic ureteroscopy (d-URS) may therefore be of crucial importance within the diagnostic framework and fundamental in establishing the appropriate therapeutic approach. Evidence acquisition and synthesis A systematic review of the literature was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Risk of bias was assessed using Risk of Bias in Non-randomized Studies of interventions (ROBINS-I). Overall, from 3791 identified records, 186 full-text articles were assessed for eligibility. Finally, after a quantitative review of the selected literature, with the full agreement of all authors, 62 studies were considered relevant for this review. Results CTU has a sensitivity and specificity for UTUC of 92% and 95% respectively, but is not able to detect small or flat lesions with adequate accuracy. The sensitivity of voided urinary cytology for UTUC is around 67–76% and ranges from 43% to 78% for selective ureteric urine collection. As no technique offers a diagnosis of certainty, d-URS can allow an increase in diagnostic accuracy. In the present review the pros and cons of d-URS were analysed. This technique may provide additional information in the selection of patients suitable for neoadjuvant chemotherapy or KSS, distinguishing between normal tissue and low- and high-grade UTUC thanks to the emerging technologies. Conclusions Information obtainable from d-URS and ureteroscopic-guided biopsy can prove extremely valuable when the diagnosis of UTUC is doubtful or KSS is being considered. Notwithstanding concerns remain regarding the potential risk of bladder recurrence, cancer dissemination, and/or delay in radical treatment. Abbreviations: CLE: confocal laser endomicroscopy; CSS: cancer-specific survival; CTU: CT urography; d-URS: diagnostic ureteroscopy; EAU: European Association of Urology; HR: hazard ratio; IMAGE1S: Storz professional imaging enhancement system; IVR: intravesical recurrence; KSS: kidney-sparing surgery; MFS: Metastasis-free survival; NAC: neoadjuvant chemotherapy; NBI: narrow-band imaging; OCT: optical coherence tomography; RFS: Recurrence-free survival; RNU: radical nephroureterectomy; ROBINS-I: Risk of Bias in Non-randomized Studies of interventions; URS(-GB): Ureteroscopy(-guided biopsy); UTUC: upper tract urothelial carcinoma; UUT: upper urinary tract

BackgroundGait compensatory mechanisms associated with partial foot amputation (PFA) and peripheral neuropathy (PN) aren’t well understood.PurposeCurrent study aimed to assess deviations in the sagittal plane kinematics and moments of the lower limb joints in PFA due to PN versus PN alone.MethodsSagittal plane ROM and moment of the ankle, knee, and hip joints were measured for 53 participants assigned into two well-matched groups: (A) 25 subjects with healed unilateral PFA and (B) 28 subjects with PN peripheral neuropathy (PN). Gait analysis was conducted using a baropodometric system and STT 3DMA system.ResultsMANOVA revealed that both groups had a similar pattern of sagittal ROM curves of lower limbs (p = 0.402). However, PFA group showed a reduction in ankle plantar flexion during the preswing (p = 0.005). Descriptive analysis of the moment curves revealed that both groups had similar compensatory patterns, specifically reduction in ankle plantar flexion moment and reversal of knee moment during late stance. However, PN group had higher values.ConclusionIndividuals with either PFA due to PN or PN alone showed similar alterations in the sagittal plane kinematics and moments of the lower limb joints; they walked cautiously with excessive dorsiflexion throughout the stance phase, and the late stance phase was the most affected, while they compensated for the reduction in the ankle plantar moment by shifting the knee moment into extension moment. The results suggested that PN, not PFA, may be the primary cause of the gait alterations and PFA surgery only worsens the compensatory mechanisms.

Purpose A large proportion of people die in the years following dysvascular partial foot amputation (PFA) or transtibial amputation (TTA) given the long-term consequences of peripheral vascular disease and/or diabetes. A critical appraisal of recent research is needed to understand the underlying cause of variation and synthesise data for use in consultations about amputation surgery and patient-facing resources. This systematic review aimed to describe proportionate mortality following dysvascular PFA and to compare this between PFA and TTA. Materials and methods The review protocol was registered in PROSPERO (CRD42023399161). Peer-reviewed studies of original research were included if they: were published in English between 1 January 2016, and 12 April 2024, included discrete cohorts with PFA, or PFA and TTA, and measured proportionate mortality following dysvascular amputation. Results Seventeen studies were included in the review. Following dysvascular PFA, proportionate mortality increased from 30 days (2.1%) to 1-year (13.9%), 3-years (30.1%), and 5-years (42.2%). One study compared proportionate mortality 1-year after dysvascular PFA and TTA, showing a higher relative risk of dying after TTA (RR 1.51). Conclusions Proportionate mortality has not changed in recent years. These results are comparable to a previous systematic review that included studies published before 31 December 2015. Implications for rehabilitation It is important to ensure data describing mortality in the years following dysvascular partial foot or transtibial amputation is up to date and accurate. Evidence about proportionate mortality has not changed in recent years and the results are comparable to previous systematic reviews. Data describing mortality outcomes can be used in decision aids that support conversations about the choice of amputation level.

Pathological gait in partial foot amputation versus peripheral neuropathy

Background:Proton-pump inhibitors (PPIs) are widely prescribed as acid-suppression therapy. Some observational studies suggest that long-term use of PPIs is potentially associated with certain adverse kidney outcomes. We conducted a systematic literature review to assess potential bias in non-randomized studies reporting on putative associations between PPIs and adverse kidney outcomes (acute kidney injury, acute interstitial nephritis, chronic interstitial nephritis, acute tubular necrosis, chronic kidney disease, and end-stage renal disease).Methods:We searched the medical literature within 10 years of 17 December 2020. Pre-specified criteria guided identification of relevant English language articles for assessment. Risk of bias on an outcome-specific basis was evaluated using the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool by two independent reviewers.Results:Of 620 initially identified records, 26 studies met a priori eligibility criteria and underwent risk of bias assessment. Nineteen studies were judged as having a moderate risk of bias for reported adverse kidney outcomes, while six studies were judged as having a serious risk of bias (mainly due to inadequate control of confounders and selection bias). We were unable to determine the overall risk of bias in two studies (one of which was assessed as having a moderate risk of bias for a different adverse kidney outcome) due to insufficient information presented. Effect estimates for PPIs in relation to adverse kidney outcomes varied widely (0.24–7.34) but associations mostly showed increased risk.Conclusion:Using ROBINS-I, we found that non-randomized observational studies suggesting kidney harm by PPIs have moderate to serious risk of bias, making it challenging to establish causality. Additional high-quality, real-world evidence among generalizable populations are needed to better understand the relation between PPI treatment and acute and chronic kidney outcomes, accounting for the effects of varying durations of PPI treatment, self-treatment with over-the-counter PPIs, and potential critical confounders.

BackgroundA new tool to assess Risk of Bias In Non-randomised Studies of Interventions (ROBINS-I) was published in Autumn 2016. ROBINS-I uses the Cochrane-approved risk of bias (RoB) approach and focusses on internal validity. As such, ROBINS-I represents an important development for those conducting systematic reviews which include non-randomised studies (NRS), including public health researchers. We aimed to establish the applicability of ROBINS-I using a group of NRS which have evaluated non-clinical public health natural experiments.MethodsFive researchers, all experienced in critical appraisal of non-randomised studies, used ROBINS-I to independently assess risk of bias in five studies which had assessed the health impacts of a domestic energy efficiency intervention. ROBINS-I assessments for each study were entered into a database and checked for consensus across the group. Group discussions were used to identify reasons underpinning lack of consensus for specific questions and bias domains.ResultsROBINS-I helped to systematically articulate sources of bias in NRS. However, the lack of consensus in assessments for all seven bias domains raised questions about ROBINS-I’s reliability and applicability for natural experiment studies. The two RoB domains with least consensus were selection (Domain 2) and performance (Domain 4). Underlying the lack of consensus were difficulties in applying an intention to treat or per protocol effect of interest to the studies. This was linked to difficulties in determining whether the intervention status was classified retrospectively at follow-up, i.e. post hoc. The overall risk of bias ranged from moderate to critical; this was most closely linked to the assessment of confounders.ConclusionThe ROBINS-I tool is a conceptually rigorous tool which focusses on risk of bias due to the counterfactual. Difficulties in applying ROBINS-I may be due to poor design and reporting of evaluations of natural experiments. While the quality of reporting may improve in the future, improved guidance on applying ROBINS-I is needed to enable existing evidence from natural experiments to be assessed appropriately and consistently. We hope future refinements to ROBINS-I will address some of the issues raised here to allow wider use of the tool.

Coronary computed tomography angiography predict one-year mortality in patients with type 2 diabetes and partial foot amputation

Background: Splenic abscess (SA) is a rare, life-threatening illness that is generally treated with splenectomy. However, this is associated with high mortality and morbidity. Recently, percutaneous drainage (PD) has emerged as an alternative therapy in select patients. In this study, we compare mortality and complications in patients with SA treated with splenectomy versus PD. Patients and Methods: A systematic literature search of 13 databases and online search engines was conducted from 2019 to 2020. A bivariate generalized linear mixed model (BGLMM) was used to conduct a separate meta-analysis for both mortality and complications. We used the risk of bias in non-randomized studies of interventions (ROBINS-I) tool to evaluate risk of bias in non-randomized studies, and the Grading of Recommendation, Assessment, Development, and Evaluation (GRADE) approach for assessing quality of evidence and strength of recommendations. Results were presented according to Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. Results: The review included 46 retrospective studies from 21 countries. For mortality rate, 27 studies compared splenectomy and PD whereas 10 used PD only and nine used splenectomy only. Data for major complications were available in 18 two-arm studies, seven single-arm studies with PD, and seven single-arm studies with splenectomy. Of a total of 589 patients, 288 were treated with splenectomy and 301 underwent PD. Mortality rate was 12% (95% confidence interval [CI], 8%-17%) in patients undergoing splenectomy compared with 8% (95% CI, 4%-13%) with PD. Complication rates were 26% (95% CI, 16%-37%) in the splenectomy group compared with 10% (95% CI, 4%-17%) in the PD group. Conclusions: Percutaneous drainage s associated with a trend toward lower complications and mortality rates compared with splenectomy in the treatment of SA, however, these findings were not statistically significant. Because of the heterogeneity of the data, further prospective studies are needed to draw definitive conclusions.