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minor amputation; bone cutter; oscillating microsaw; outcomes research; reintervention after toe amputation
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Power Foley M, Westby D, Aherne T and Walsh S. Bone Cutter versus Oscillating Saw for Ray Amputation: A Protocol for Randomised Controlled Feasibility Trial comparing Outcomes between Metatarsal Methods of Transection (MetaMet) [version 1; peer review: 1 approved with reservations]. HRB Open Res 2024, 7:61 (https://doi.org/10.12688/hrbopenres.13910.1)
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Study Protocol
Bone Cutter versus Oscillating Saw for Ray Amputation: A Protocol for Randomised Controlled Feasibility Trial comparing Outcomes between Metatarsal Methods of Transection (MetaMet)
[version 1; peer review: 1 approved with reservations]
PUBLISHED 04 Oct 2024
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Abstract
Corresponding author:
Megan Power Foley
Competing interests:
No competing interests were disclosed.
Grant information:
Funding for open-access publication was provided by the National Surgical Research Support Centre at the Royal College of Surgeons in Ireland.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright:
© 2024 Power Foley M et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Power Foley M, Westby D, Aherne T and Walsh S. Bone Cutter versus Oscillating Saw for Ray Amputation: A Protocol for Randomised Controlled Feasibility Trial comparing Outcomes between Metatarsal Methods of Transection (MetaMet) [version 1; peer review: 1 approved with reservations]. HRB Open Res 2024, 7:61 (https://doi.org/10.12688/hrbopenres.13910.1)
First published: 04 Oct 2024, 7:61 (https://doi.org/10.12688/hrbopenres.13910.1)
Latest published: 04 Oct 2024, 7:61 (https://doi.org/10.12688/hrbopenres.13910.1)
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Background
Ray amputation is a common minor operation performed by vascular, orthopaedic, and pediatric surgeons. It is increasingly required for the management of irretrievable diabetic foot infections with or without concurrent ischemia. The intersection between diabetes mellitus, neuroischemic foot ulceration, and lower limb amputation is well established1. As the incidence of diabetes and diabetes-related complications increases globally, the volume of lower extremity amputations (LEAs) has correspondingly risen, particularly minor amputations2–4. This increase in minor LEAs without a corresponding increase in major amputations may represent an earlier therapeutic intervention and successful limb salvage efforts.
However, ‘minor’ amputations are associated with prolonged hospital admissions and significant financial costs; they negatively impact patients’ quality of life, mobility, and independence and may be a harbinger of subsequent major amputation5–7. High rates of re-ulceration, re-infection, readmission to hospital, and re-amputation after partial foot resection for digital gangrene are described in both diabetic and PAD cohorts8. According to the literature, rates of re-amputation at five years post-index surgery for diabetic foot complications ranged from 45–65%8–11. One year after toe amputation, Littman et al. reported that 34% of 17,786 patients underwent re-amputation, with 10% going on to have a major LEA12.
Healthcare resource utilisation notwithstanding, the financial costs of managing diabetic foot complications are estimated to outstrip some cancers13,14. As the prevalence of diabetes mellitus increases among the aging population, achieving durable functional outcomes after partial foot amputation is paramount. The aim of this randomized controlled trial was to compare outcomes between two different methods of transecting the metatarsal shaft, a critical step in performing toe amputation. If a surgical technique produces superior wound-healing rates, it should be adopted by the surgical community.
Trial rationale
Numerous studies have investigated patient-dependent factors predictive of amputation failure and various postoperative adjuncts to wound healing, such as negative pressure wound therapy and topical oxygen therapy15,16. Chronic kidney disease, diabetes with or without poor glycemic control, peripheral neuropathy, peripheral arterial disease, continued tobacco smoking, obesity, and sepsis at the time of index operation have all been identified as independent risk factors for amputation failure and need for revision7,17,18. However, there is a dearth of evidence on the impact of technical surgical factors on the outcomes of this commonly performed procedure. Although there are numerous facets of perioperative care that could be analyzed, we decided to focus this study on the impact of the metatarsal transection method on outcomes after ray amputation, specifically comparing a manual bone cutter or an oscillating microsaw.
We hypothesized that utilizing a manual bone cutter is subject to more inter-user variability, as it depends on the physical strength of the operating surgeon. Improperly applied forces are liable to fracture the remaining bone, leaving small comminuted fragments that may become necrotic and act as nidus for further infection within the wound bed. Conversely, an oscillating microsaw has the advantage of providing clean bony transection regardless of the physical strength of the operator; however, it may cause more damage to the surrounding connective tissues and disturb the microvascular periosteal supply, which could also lead to osteonecrosis. To our knowledge, this is the first study to investigate the impact of surgical techniques on wound healing and reoperation rates after toe amputation.
Objectives
The principal research question for this feasibility study was to collect sufficient data to enable an accurate power calculation for a future randomized controlled trial.
The secondary objectives are the following:
1. To determine the effect of the metatarsal transection method on rates of surgical re-intervention to the index wound and adjacent tissues at six months;
2. To determine the effect of the metatarsal transection method on rates of hospital readmission for complications secondary to index procedures at six months;
3. To determine the effect of the metatarsal transection method on rates of surgical re-infection in the index surgical wound at six months;
4. To determine the effect of the metatarsal transection method on the median time from surgery to the healing of the index wound.
5. To determine the impact of the metatarsal transection method on the quality of the proximal bony specimen sent for microbial culture from the index procedure.
6. To assess the impact of the metatarsal transection method on patient-reported postoperative pain, as measured by the Verbal Rating Scale (VRS) at twenty-four hours after the surgical procedure19,20.
7. To assess the impact of the metatarsal transection method on patient-reported health-related quality of life (HR-QoL) at six weeks and six months post-operatively, as measured using the EQ-5D-5L tool21
Trial design and endpoints
State of design
This trial was designed in accordance with the SPIRIT reporting guidelines for trial protocols22. This was a prospective, randomized controlled, assessor-blinded, feasibility study with participants allocated to one of the two parallel groups in a 1:1 fashion using randomization by minimization. The operating surgeon is aware of the type of surgery performed. The nature of the intervention (metatarsal amputation using either a bone saw or a bone cutter) ensures that both the patient and assessor can be blinded, so long as the assessor is not the operating surgeon. Patients undergoing toe amputation via spinal or local anesthesia will be provided with headphones to ensure that they do not overhear what equipment is requested. Evaluation of postoperative X-rays will be performed by a designated trial radiologist who will be blinded to the intervention. All statistical analyses were blinded. The primary trial center will be the University Hospital Galway, Ireland, with other centers also evaluated for inclusion. Appropriate patients should be recruited from both the outpatient and inpatient settings. Procedures may be classified as Emergent, Urgent or Elective.
Outcomes
The primary efficacy outcome will be the number of patients in each group who underwent surgical reintervention six months postoperatively.
The primary safety endpoint was the rate of vascular-related postoperative complications.
The secondary outcome will be to compare the effect of oscillating microsaw to bone cutters on metatarsal shaft transection during toe amputation for the following outcomes:
1. Rate of surgical reintervention on the ipsilateral foot at six months;
2. Rate of hospital readmission for complications secondary to the index procedures at six months;
3. Rate of re-infection in the index surgical wound at six months;
4. Median time from surgery to healing of the index surgical wound;
5. Rate of ulcer recurrence on the ipsilateral foot at six months;
6. Rate of recurrence of osteomyelitis in the ipsilateral foot at six months;
7. Rate of positive microbial culture from the most proximal bone specimen from surgical resection;
8. Patient-reported postoperative pain, as measured by the Verbal Rating Scale (VRS) at twenty-four hours after the surgical procedure19,20.
9. Patient-reported health-related quality of life (HR-QoL) at six weeks and six months post-operatively, as measured using the EQ-5D-5L tool21
Trial protocol
The flow of the study is outlined in Figure 1.
Figure 1. Flow chart of the study.
Inclusion criteria
Consenting patients aged 18 years and over undergoing transmetatarsal amputation of a single toe or two adjacent toes. Patients will be stratified by pulse status (at least one pedal palpable vs. both pedal pulses impalpable) and chronic kidney disease (eGFR >60 and eGFR <60 mL/min/1.73 m2), considering both are significant factors in predicting wound healing.
Exclusion criteria
1. Patients with significant peripheral arterial disease, as defined by an ABPI <0.4 or digital pressures of < 50 mmHg, not undergoing concurrent revascularisation.
2. Patients unfit for surgery;
3. Patients unable to provide informed consent;
4. Patients undergoing en-bloc resection of three or more toes;
5. Patients undergoing partial toe amputation without transection of the metatarsal shaft.
Informed consent of the inpatient
Informed consent will be obtained in compliance with the principles of good clinical practice and within the rules set down by the Research Ethics Committee. Prior to consenting to the study, each participant was provided with a full written and verbal explanation, and sufficient time was provided for full consideration. Any queries that they have answered. If they agree, the participant will sign the consent form and a copy of this will be given to them. At any time, the participant may withdraw from the study without prejudice or any effect on their treatment.
Informed consent of the outpatient
The study will be discussed verbally with eligible patients seen in the outpatient setting, and documentation will be provided. At that time, they will be asked to give their consent, and they will be asked again on the day of surgery.
Randomisation
Considering the myriad of factors impacting healing after toe amputation, randomization by minimization will be generated centrally using third-party computer software (Sealed Envelope) to ensure equal distribution of patients in each cohort after the consent process. A unique trial number was assigned to each individual at the time of randomization. Patients will be randomized in a 1:1 ratio into one of the two groups.
- Group 1: Metatarsal shaft will be transected using a Bone Cutter
- Group 2: Metatarsal shaft will be transected using an Oscillating Microsaw
On the day of surgery, a nominated independent member of the surgical team will access the randomization software and show the operating surgeon. Randomization will be performed per patient and not per toe amputation; as such, a single patient undergoing two or more toe amputations simultaneously will only be randomized once. There will be no sham intervention.
Baseline medical data
Patients will have a complete medical history and clinical examination as part of their standard care. The following are recorded:
1. Weight;
2. Height;
3. Gender;
4. Ethnicity;
5. Date of Birth;
6. Diabetes mellitus and glycaemic control, defined as the most recent HbA1c;
7. Insulin requirement for diabetic patients;
8. Hypercholesterolaemia;
9. Hypertension;
10. Previous myocardial infarction;
11. Previous coronary revascularisation;
12. Previous stroke;
13. Atrial fibrillation;
14. Peripheral arterial disease;
15. Smoking history;
16. Recent ipsilateral lower limb revascularisation;
17. ABPI +/- TPI in the index limb;
18. Chronic kidney disease, as defined by eGFR;
19. Baseline blood at hospital admission, including white blood cell count, neutrophil count, hemoglobin, mean corpuscular volume, CRP, creatinine, urea, albumin, and total protein.
20. Medications at index admission;
21. Baseline radiographic findings, including degree of osteomyelitis, osteopenia, and soft tissue gas
22. Baseline microbiology findings, from wound swab and/or bone specimen
The data collection protocol outlined the variables collected at baseline and at each follow-up interval to define variations among and within groups.
Ulcer assessment
Any ulcer present on the toe to be amputated at the time of consent and prior to randomization will be evaluated by an experienced assessor and documented in the patient’s medical notes, as is standard practice. Wound assessment will be performed using the Wound, Ischemia, and foot Infection (WIfI) score, which has been validated for digital ulcers in patients with chronic limb-threatening ischemia and diabetes23.
Ankle brachial pressure indices
All patients in whom pedal pulses are impalpable will have an ankle-brachial pressure index (or toe pressure index for diabetics or patients with chronic kidney disease) recorded for the ipsilateral and contralateral limbs by a trained vascular technologist.
Plain film radiographs (X-Ray)
As is standard practice, radiography of the ipsilateral foot will be performed on admission for all patients. This will assess the loss of the bony cortex or bony erosion, typical of osteomyelitis or osteonecrosis, and the presence of soft tissue gas suggestive of acute infection with a gas-producing organism, indicating that the patient requires emergent debridement. Furthermore, an inconclusive X-ray can indicate whether the patient may benefit from further imaging, such as MRI. The results from this scan will be used as baseline for pre-intervention radiographs.
Feasibility data
1. The number of eligible patients
2. The number of consenting patients
3. The number of patients declining participation
4. Assessment of the number of patients who attend or miss scheduled follow-up
5. Reasons for missed follow-up appointments
6. Barriers to timely scheduling of interventions and follow-up
Interventions
All procedures will be performed by a consultant vascular surgeon or surgical registrar with significant experience. With the exception of the metatarsal transection method selected by randomization, each procedure will be performed as per standard practice. As both the methods being compared in this study are part of routine practice, surgeons will be familiar with their use, and a learning curve is not anticipated. Procedures may be performed under general anesthesia, spinal anesthesia, or regional anesthesia, as determined by the supervising consultant anesthetist. All patients will receive saline wound lavage and wounds with extensive contamination will receive washout with 50% hydrogen peroxide solution, which is the standard of care. The most proximal specimen of the bony resection will be sent for culture and sensitivity to the microbiology laboratory. The use of the drain and closure material was left to the discretion of the operating surgeon. Continuation of antibiotics will be as per local microbiology guidelines and tailored to culture and sensitivity results from intraoperative bone specimens. The use of VAC or wound adjuncts will also be documented.
Bone cutter
After the metatarsophalangeal joint is disarticulated, connective tissues and periosteum are stripped off the metatarsal shaft to allow the insertion of the jaws of the bone cutter. A manual force was applied to cut the bones. In circumstances where the bone is not transected cleanly, smoothening the residual sharp edges with a bone rasp or nibbler may be required.
Schedule of events
Follow-up
All patients will be fully assessed at 48 hours postoperatively and again at six weeks. A final assessment will take place at six months. Follow-up will be performed by assessors who are blinded to the intervention.
X-ray
All patients will have a baseline foot radiograph performed preoperatively, as is the standard of care when determining whether a ray amputation is necessary. As part of the trial follow-up, the patients underwent two follow-up X-rays of the ipsilateral foot. The first within 48 hours of surgery to assess bony fragments and a second at six months post-operatively to assess bony healing, as is common practice in orthopaedic surgery. All X-rays will be reported by a consultant radiologist blinded to the intervention.
Patient-reported post-operative pain
Patient-reported postoperative pain will be evaluated within 48 h of surgery using the Verbal Rating Scale (VRS).
Patient-reported quality of life (EQ5D questionnaire)
Patient-reported health-related quality of life will be evaluated by the completion of the EQ5D form at six weeks and six months. These data will be further utilized to generate health economic data.
Wound care and recurrence of ulceration or infection
Any recurrence of symptoms, postoperative complications, or concerns were recorded. As per the usual vascular practice, patients will be followed up in the community post-discharge and receive regular wound care from public health nurses. To determine the approximate time from surgery to wound healing, sequential wound pictures will be sent on a fortnightly basis by the PHN to a secure HSE email account used by trial investigators.
Crossovers
We expect a certain degree of crossover from the bone cutter trial arm to the bone saw trial arm, as reflected in daily surgical practice. The availability of surgical instruments shared among multiple surgical services is anticipated to be a factor. Furthermore, patient and operator characteristics, such as the density of the metatarsal shaft bone and operator strength, may also necessitate a crossover between groups.
Withdrawals during follow-up
At any time, the participant may withdraw from the trial without bearing on any further management or intervention. The principal investigator may also decide to remove anyone at any time if this is in the best interest of the patient or if they meet the exclusion criteria.
Loss to follow-up
During the consent process, the participants will be educated regarding the importance and timing of the follow-up protocol. Regular post-intervention patient contact in the community through public health nurses and vascular clinical nurse specialists working in the wound clinic in Roscommon Hospital will allow for continued patient dialogue regarding follow-up. Should follow-up appointments be missed, investigators will endeavor to contact patients by phone or via community liaisons to ensure timely follow-up within the trial protocol. Any loss to follow-up will be documented and explained in the trial data to the best ability of the investigator. Any reasons for not being able to attend were recorded.
Protocol violations
The following will be deemed a protocol violation and the participant will be removed from the trial:
Premature termination of the study
The trial may be temporarily suspended or terminated prematurely if there is a sufficiently reasonable cause. Written notifications documenting the reason for trial suspension or termination will be provided to the regional ethical committee and all trial investigators by the principal investigator.
Circumstances that may warrant termination or suspension include, but are not limited to:
Schedule of events
Figure 2 shows the schedule of events.
Figure 2. SPIRIT Table outlining sequence of events.
Safety parameters
Potential adverse events related to intervention
The risk of any significant adverse events was deemed unlikely. All reasonable measures were undertaken to avoid these events. Notably, this trial compared two accepted methods of performing a common operation and did not involve any experimental procedures; therefore, attributing adverse events to the trial intervention rather than patient comorbidities will be challenging. Any adverse events (as described below) that occur will be recorded and reported in any trial.
1. Bleeding requiring takeback to theatre for hemostasis or requiring transfusion of >1 unit packed red cells with corresponding drop in Hb >1 g/dl ;
2. Surgical site infection
3. Venous thromboembolism;
4. Myocardial infarction;
5. Adverse reaction to local or general anaesthetic;
6. Major ipsilateral amputation, either below-knee amputation or above-knee amputation
Definition of an adverse event
An adverse event is defined as any untoward medical event related directly or indirectly to an intervention as a result of participation in the trial.
Definition of a serious adverse event
Any unexpected event that results in death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect, is deemed a serious adverse event.
Event reporting
All adverse events will be reported directly to either the site or principal investigator. Recurrent adverse events or serious adverse events in isolation will be reported to the local Ethical Committee and risk assessment department for risk analysis. Indications for premature trial cessation are discussed in the ‘Protocol Violations’ section.
Trial audit
A regular audit of trial conduct was conducted throughout the study period. The project management group (MPF, DW, SRW) shall convene tri-monthly to review trial proceedings internally and address methodological, clinical, and ethical concerns. External review shall be undertaken every 12 months by the local research ethics committee, with further data monitoring from an independent research advisor from the National University of Ireland, Galway.
Statistical considerations
Once randomization and intervention are complete, patient outcomes will be assessed using intention-to-treat analysis. We expect a certain degree of crossover from the bone cutter trial arm to the bone saw trial arm, as reflected in daily surgical practice. Furthermore, we expect that a small number of patients will ultimately not undergo treatment as initially planned. All loss to follow-up at any time point was recorded and reported.
A blinded research statistician will conduct all the statistical analyses using SPSS Version 28 (IBM Corp., Armonk, NY, USA). Descriptive data will be provided at baseline and at each follow-up interval to define variations among and within groups, as per the data collection sheet. Continuous data are presented as means and standard deviations with 95% confidence intervals. Categorical data will be reported as frequencies, with the chi-square or Fischer’s exact t-test used for comparative data. Where data are not normally distributed, non-parametric tests will be utilized as applicable. The time between surgery and measurable endpoints was compared using Kaplan-Meier Survival curves. Statistical significance was set at p value <0.05.
There are no studies investigating this particular trial question; as such, there are no data on which to base a power calculation. For this pilot trial, we aimed to recruit 20 patients into each arm, for a total of 40 patients. The primary aim of this study was to collect sufficient data to generate a sample size calculation for an appropriately powered study that would allow for the control of confounding factors that impact ulcer healing. As the sample size was small, there was no need for interim analysis.
Study status
This study is currently actively recruiting in University Hospital Galway.
Ethical considerations
Discussion
Significant efforts have been made to identify patient factors that influence the progression from minor to major LEA. Chronic kidney disease, diabetes mellitus, peripheral neuropathy, smoking, obesity and malnutrition all impact wound healing7,17,18. Although helpful from a risk stratification viewpoint, such factors are largely unmodifiable by the time a patient requires a minor LEA. There is a need to switch focus from characterising the patients who progress to limb loss and instead engage in the task of identifying the optimal surgical techniques for these challenging patients. concurrent revascularisation for wounds with an ischemic component is recommended24. Numerous intra- and post-operative therapeutic adjuncts have also been studied. The supporting evidence for local antibiotic delivery devices, such as impregnated sponges, beads, and cement, intended to deliver a high concentration of antibiotics into the wound bed has been inconclusive25. Postoperatively, vacuum-assisted closure (VAC) therapy has demonstrated variable success with improved healing and reduced healing time in diabetic foot ulcers15. However, wound adjuncts such as topical oxygen therapy have reported less consistent outcomes26. To date, minimal research has focused on surgical techniques and their impact on wound healing and reulceration.
As part of the development process for this study, we performed a systematic review of the existing literature investigating surgical techniques, such as methods of bony resection, management of articular cartilage, and wound closure, on outcomes after toe amputation. After an exhaustive search, we identified several papers reporting on the technical aspects of utilizing various soft tissue flaps for covering wound defects and a case series reporting the outcomes of primary closure in semi-elective diabetic minor amputations. To the best of our knowledge, no single trial or case-control study has compared methods of bony transection. Although other aspects of vascular surgical practice have been rigorously investigated and guidelines reflect evidence-based medicine, there is minimal supporting data on how digital amputation is performed. Bone nibblers, cutters, or a saw may be used to transect the metatarsal shaft, depending on the institutional convention, equipment availability, and surgeon preference. The apprenticeship model of surgical training may have contributed to variation in practice.
We contend that using an oscillating microsaw to transect the metatarsal shaft should produce a cleaner bone end with less soft tissue damage and bony debris than a manual bone cutter, thereby reducing the risk of recurrent infection within the wound bed and subsequent wound breakdown. This randomized controlled feasibility study aimed to provisionally compare the value and safety profiles of two different surgical techniques. An initial feasibility study was selected because a significant number of patients are needed to power a full study. We planned to recruit patients from multiple sites after the initial cohort was selected.
Declarations
Ethics approval and consent to participate
Ethical approval for trial recruitment was granted by the Clinical Research Ethics Committee for the Soalta Hopsital Group on 12th May 2022 (reference CA 122/22 Galway Clinical Research Ethics Committee). The study will be conducted in accordance with the Helsinki Declaration for research on human participants.
Status of Trial
Protocol: 1. V2
Recruitment: commenced February 2023
Estimated Completion Date: December 2024
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Power Foley M, Westby D, Aherne T and Walsh S. Bone Cutter versus Oscillating Saw for Ray Amputation: A Protocol for Randomised Controlled Feasibility Trial comparing Outcomes between Metatarsal Methods of Transection (MetaMet) [version 1; peer review: 1 approved with reservations]. HRB Open Res 2024, 7:61 (https://doi.org/10.12688/hrbopenres.13910.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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How to cite this report:
Kochhar K. Reviewer Report For: Bone Cutter versus Oscillating Saw for Ray Amputation: A Protocol for Randomised Controlled Feasibility Trial comparing Outcomes between Metatarsal Methods of Transection (MetaMet) [version 1; peer review: 1 approved with reservations]. HRB Open Res 2024, 7:61 (https://doi.org/10.21956/hrbopenres.15256.r43893)
The direct URL for this report is:
https://hrbopenresearch.org/articles/7-61/v1#referee-response-43893
https://hrbopenresearch.org/articles/7-61/v1#referee-response-43893
NOTE: it is important to ensure the information in square brackets after the title is included in this citation.
Reviewer Report 19 Dec 2024
Kanika Kochhar,
University of Michigan Michigan Medicine (Ringgold ID: 21614), Ann Arbor, Michigan, USA
Approved with Reservations
VIEWS 6
The study design appears appropriate and has academic merit. However, several aspects need clarification and standardization to improve the study's reproducibility:
Postoperative Weight-Bearing Status
Postoperative Weight-Bearing Status
- Is the postoperative weight-bearing status standardized among all patients?
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Kochhar K. Reviewer Report For: Bone Cutter versus Oscillating Saw for Ray Amputation: A Protocol for Randomised Controlled Feasibility Trial comparing Outcomes between Metatarsal Methods of Transection (MetaMet) [version 1; peer review: 1 approved with reservations]. HRB Open Res 2024, 7:61 (https://doi.org/10.21956/hrbopenres.15256.r43893)
The direct URL for this report is:
https://hrbopenresearch.org/articles/7-61/v1#referee-response-43893
https://hrbopenresearch.org/articles/7-61/v1#referee-response-43893
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Alongside their report, reviewers assign a status to the article:
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A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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