Reprocessed Single-Use Semicritical and Critical Medical Devices

May combine two claims.

Most included studies were of very low to moderate quality, which limits confidence in the observed outcomes resulting from reuse of these devices.

“Most of the included studies were of very low to moderate quality, which limits confidence in the observed outcomes resulting from the reuse of these devices.”

May combine two claims.

The Plante et al. study was a prospective cohort study evaluating balloon catheters for coronary angioplasty at 2 sites in the same province in Canada, with 1 site using reprocessed single-use catheters and 1 site using new catheters.

“The Plante et al. 17 study was a prospective cohort study evaluating balloon catheters for coronary angioplasty at 2 sites in the same province in Canada, with 1 site using reprocessed single-use catheters and 1 site using new catheters.”

• cites [17]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Leung et al., loss to follow-up was not reported and a power calculation was not described.

“Loss to followup was not reported, a power calculation was not described”

May combine two claims.

In Browne et al., follow-up for fever, chills, and elevated WBC was reported only up to 24 hours postprocedure, and patients were followed only until hospital discharge, with no long-term follow-up.

“Follow-up for fever, chills and elevated WBC was reported only up to 24 hours postprocedure, and therein patients were followed only until hospital discharge.There was no long-term follow-up.”

May combine two claims.

All included studies evaluated single-use medical devices classified as critical, and all were conducted in surgical settings.

“All included studies evaluated SUMDs classified as critical, and all were conducted in surgical settings; however, it is unclear whether patient risk levels would be different for semicritical devices or in nonsurgical settings.”

May combine two claims.

In Plante et al., at baseline there were statistically significant differences in the incidence of unstable angina (and related IV heparin and nitroglycerin use before the procedure) between the 2 centres, which may suggest that more high-risk lesions were treated in the reprocessed device group.

“At baseline, there were statistically significant differences in the incidence of unstable angina (and related IV heparin and nitroglycerin use before the procedure) between the 2 centres, which may suggest that more high-risk lesions were treated in the reprocessed device group.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Browne et al., the study was powered to detect a 5% difference in angiographic failure rates of new and reused balloons, yet the failure rate for the comparison group did not appear to be provided.

“The study was powered to detect a 5% difference in the angiographic failure rates of new and reused balloons, yet the failure rate for the comparison group did not appear to be provided.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Jokar et al., there was no description of blinding of patients or outcome assessors or allocation concealment.

“There was no description of blinding of patients or outcome assessors or allocation concealment.”

May combine two claims.

In Zacharias et al., there was no description of the patient groups or any indication of how patients were selected or assigned to treatment.

“There was no description of the patient groups or any indication of how the patients were selected or assigned to treatment.”

May combine two claims.

In Browne et al., the retroactive comparison group was not well-described and a list of potential confounders was not provided.

“The retroactive comparison group was not well-described, and a list of potential confounders was not provided.”

May combine two claims.

The literature search identified 8 publications meeting inclusion criteria, comprising 1 randomized controlled trial and 7 nonrandomized studies.

“Of these potentially relevant articles, 25 publications were excluded for various reasons, and 8 publications met the inclusion criteria and were included in this report.These comprised 1 randomized controlled trial (RCT), and 7 nonrandomized studies.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Jokar et al., there appears to be a small loss to follow-up of 3 patients that was not reported or addressed by the authors, though this small number is unlikely to have impacted observed outcomes.

“There appears to be a small loss to follow-up of 3 patients that was not reported or addressed by the authors, though this small number is unlikely to have impacted the observed outcomes.”

Classified as probably not a substantial claim. May combine two claims.

Browne et al. 15 reported that it is unknown how many cycles of restoration a single balloon angioplasty catheter can tolerate, and that data are required to evaluate the degradation of these products with each subsequent cycle.

“Browne et al. 15 reported that it is unknown how many cycles of restoration a single balloon angioplasty catheter can tolerate, and that data are required to evaluate the degradation of these products with each subsequent cycle.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim. May combine two claims.

Plante et al. 17 emphasized that before a policy of balloon catheter reuse is initiated, it is imperative to establish clear and rigorous guidelines for cleaning and sterilization, with adequate monitoring and quality control in place at all stages.

“Plante et al. 17 have emphasized that before a policy of balloon catheter reuse is initiated, it is imperative to establish clear and rigorous guidelines for cleaning and sterilization, and with adequate monitoring and quality control in place at all stages.”

• cites [17]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Browne et al. 15 reported incidence of device failure was 7%, which the authors claim compares with a 10% rate reported in the literature for new balloon catheters.

“The incidence of device failure was 7%, which the authors claim compares with a 10% rate reported in the literature for new balloon catheters.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Marins et al. 22 reported no reoperations in either group.

“There were no reoperations in either group.”

• cites [22]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

In Marins et al., length of follow-up and loss to follow-up were not reported, and a power calculation was not performed.

“Length of follow-up and loss to follow-up were not reported, and a power calculation was not performed.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Marins et al. 22 reported duration of the surgical intervention was on average 2 hour and 23 minute (P = 0.161).

“The duration of the surgical intervention was on average 2 hour and 23 minute (P = 0.161)”

• cites [22]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Colak et al. 16 reported total incidence of complications (3.2% vs 4.8%, P = 0.50) and infection rates (1.6% vs 3.2%, P = 0.57) were similar.

“The total incidence of complications (3.2% vs 4.8%, P = 0.50) and infection rates (1.6% vs 3.2%, P = 0.57) were also similar.”

• cites [16]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim. May combine two claims.

Browne et al. 15 emphasized important differences between in vitro evaluation and in vivo evaluation and stated that methods of restoration must be highly controlled and reproducible.

“Browne et al. 15 emphasized the important differences between in vitro evaluation and in vivo evaluation and stated that methods of restoration must be highly controlled and reproducible.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Most of the included studies had limited follow-up, so long-term outcomes for many patients were not available.

“Most of the included studies had limited follow-up, so long-term outcomes for many patients were not available.”

May combine two claims.

Three studies evaluated the same study population, patients undergoing laparoscopic cholecystectomy, but each evaluated a different intervention: disposable laparoscopic instruments, plastic trocars, and surgical ports.

“Three studies evaluated the same study population, patients undergoing laparoscopic cholecystectomy, but in each case evaluated a different intervention: disposable laparoscopic instruments, 16 plastic trocars, 18 and surgical ports.21”

• cites [16]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [18]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [21]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Among reprocessed probes in Zacharias et al. 20, 201 (93.5%) were functioning and 14 (6.5%) were nonfunctioning (P < 0.001) for an odds ratio OR = 12.99 (P < 0.001).

“Among the reprocessed ones, 201 (93.5%) were functioning and 14 (6.5%) were nonfunctioning (P < 0.001) for an odds ratio OR = 12.99 (P < 0.001).”

• cites [20]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

The 2 studies that reported on the same intervention (balloon catheters) in the same population (coronary angiography) came to different conclusions, with Plante et al. 17 reporting higher rates of adverse events and other procedure-related issues in the reprocessed SUMD group, while Browne et al. 15 described much more favourable results.

“The 2 studies that reported on the same intervention (balloon catheters) in the same population (coronary angiography) came to different conclusions, with Plante et al 17 reporting higher rates of adverse events and other procedure-related issues in the reprocessed SUMD group, while Browne et al 15 described much more favourable results.”

• cites [17]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Most of the 8 studies employed a different reprocessing protocol and evaluated different reprocessed SUMDs in patients undergoing different surgical interventions.

“most of which employed a different reprocessing protocol, and evaluated different reprocessed SUMDs in patients undergoing different surgical interventions.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Gundogdu et al. 18 focused mainly on nonpatient outcomes in a prospective cohort study.

“Gundogdu et al. 18 focused mainly on nonpatient outcomes in a prospective cohort study.”

• cites [18]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Plante et al. 17 reported overall clinical success rate and rate of clinical failure without adverse clinical events were comparable in the 2 groups.

“Overall clinical success rate and the rate of clinical failure without adverse clinical events were comparable in the 2 groups.”

• cites [17]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Colak et al. 16 reported no statistically significant difference between the new and the reprocessed disposable laparoscopic instrument groups in mean operating time, LAS, duration and amount of analgesic administration, or hospital stay.

“Colak et al. 16 reported that there was no statistically significant difference between the new and the reprocessed disposable laparoscopic instrument groups in mean operating time, LAS, duration and amount of analgesic administration, or hospital stay.”

• cites [16]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Device failure was not reported for the comparison group in the retrospective review in Browne et al. 15.

“Device failure was not reported for the comparison group in the retrospective review.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

The only patient outcome reported in Gundogdu et al. 18 was infection, evaluated using Cruise's criteria.

“The only patient outcome reported was infection which was evaluated using Cruise's criteria.”

• cites [18]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

In Jokar et al. 21, all PSIs were considered superficial, and no symptoms of deep infection were reported.

“All PSIs were considered superficial, and no symptoms of deep infection were reported.”

• cites [21]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

For laparoscopic cholecystectomy patients, use of reprocessed surgical ports led to a significant increase in PSI, while use of reprocessed plastic trocars and other disposable laparoscopic instruments reportedly did not increase infection rates.

“For laparoscopic cholecystectomy patients, the use of reprocessed surgical ports led to a significant increase in PSI, 21 while the use of reprocessed plastic trocars and other disposable laparoscopic instruments reportedly did not increase infection rates.16,18”

• cites [21]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [16]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [18]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Browne et al. 15 reported mean procedure time was 67 minutes in the reprocessing group compared with 83 minutes in the comparison group.

“Browne et al. 15 reported that the mean procedure time was 67 minutes in the reprocessing group compared with 83 minutes in the comparison group.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Browne et al. 15 reported mean fluoroscopy time was 13 minutes in the reprocessing group compared with 18 minutes in the comparison group.

“The mean fluoroscopy time for the procedures was 13 minutes in the reprocessing group compared with 18 minutes in the comparison group.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Of the 8 included studies, only 2 studies evaluated the same device in the same population (balloon catheters for coronary angiography 15,17) while the rest evaluated a variety of devices across different populations.

“Of the 8 included studies, only 2 studies evaluated the same device in the same population (balloon catheters for coronary angiography 15,17 ) while the rest of the included studies evaluated a variety of devices across different populations.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [17]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Among original probes in Zacharias et al. 20, 373 (99.47%) were functioning and 2 (0.53%) were nonfunctioning.

“Among the original probes, 373 (99.47%) were functioning and 2 (0.53%) were nonfunctioning.”

• cites [20]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim.

Outcomes were reported in which the impact on patient outcomes was not made clear.

“In addition, outcomes were reported in which the impact on patient outcomes was not made clear.”

May combine two claims.

Marins et al. 22 reported hospital mortality in the reprocessing group was 1.90% (6 deaths), and 2.88% (12 deaths) in the nonreprocessing group.

“Hospital mortality in the reprocessing group was 1.90%, resulting in 6 deaths, and it was 2.88% (12 deaths) in the nonreprocessing group.”

• cites [22]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Marins et al. 22 point out that stringent criteria allow the detection of any type of anomaly, which is not the case in original medical devices whose quality control is done by sampling.

“They point out that these stringent criteria allow the detection of any type of anomaly, which is not the case in original medical devices whose quality control is done by sampling.”

• cites [22]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Three studies (2, 15, 19) used third-party reprocessing or remanufacturing of SUMDs, while the rest described in-hospital reprocessing protocols that varied by institution.

“Three studies 2,15,19 used third-party reprocessing or remanufacturing of SUMDs, while the rest described in-hospital reprocessing protocols that varied by institution.”

• cites [2]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [19]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Studies evaluating semicritical devices were not identified, and all included studies evaluated critical category devices in surgical settings.

“Studies evaluating semicritical devices were not identified, and all included studies evaluated critical category devices in surgical settings.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Browne et al. 15 reported mean dye volume was 275 mL compared with 307 mL in the comparison group.

“The mean dye volume was 275 mL compared with 307 mL in the comparison group.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim.

Browne et al. 15 reported that using simple methods of cleaning and decontamination followed by radiation sterilization does not offer enough of a guarantee of safety to permit reuse.

“Browne et al. 15 also reported that using simple methods of cleaning and decontamination followed by radiation sterilization does not offer enough of a guarantee of safety to permit reuse.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

No patient in the control group had chills, while 1 person in the reprocessing group had chills.

“No patient in the control group had chills, while 1 person in the reprocessing group had chills.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Marins et al. 22 emphasize that a certified reprocessing process requires rigorous inspection, with demanding criteria and guidelines specific to each device.

“Marins et al 22 emphasize that a certified reprocessing process requires rigorous inspection, with demanding criteria and guidelines specific to each device.”

• cites [22]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Although the Marins et al. study scored well in external validity and generalizability and in many aspects related to confounding and bias, it had flaws typical of observational studies, including lack of randomization of patients to each intervention arm with assignment concealment, and no blinding of patients and outcome assessors described.

“Although the study scored well in terms of external validity and therefore generalizability, and also in many aspects related to confounding and bias, it had a few flaws typical of observational studies, including lack of randomization of patients to each intervention arm with assignment concealment, and there was no blinding of patients and outcome assessors described.”

May combine two claims.

Plante et al. 17 used an in-house reprocessing protocol, whereas Browne et al. 15 used a third-party reprocessor.

“However, Plante et al 17 used an in-house reprocessing protocol, whereas Browne et al 15 used a third-party reprocessor”

• cites [17]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

In Jokar et al. 21, individuals in the disposable port group had a maximum of 2 symptoms of superficial infection, but there were usually more than 2 symptoms in the reprocessed port group.

“Individuals in the disposable port group had a maximum of 2 symptoms of superficial infection, but there were usually more than 2 symptoms in the reprocessed port group.”

• cites [21]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims. The quote only partly states this claim.

In Plante et al. (1994), the volume of contrast medium was 201 mL +/-86 in the reprocessed group versus 165 +/-61 mL in the new device group, P<0.025.

“Volume of contrast medium: 201 mL +/-86”

• Also stated in: § Additional information · plain

  “165 +/-61 mL medium: Volume of contrast”

May combine two claims.

In Plante et al. (1994), the clinical failure rate with adverse clinical events was 7.8% (n=25) in the reprocessed group versus 3.8% (n=14) in the new device group, P<0.025.

“Clinical failure with adverse clinical events: n = 25 (7.8%)”

• Also stated in: § Additional information · plain

  “Clinical failure with adverse clinical events: N = 14 (3.8%) P < 0.025”

May combine two claims. The quote only partly states this claim.

In Plante et al. (1994), the initial balloon failure rate was 10.2% in the reprocessed group versus 3.3% in the new device group, P<0.0001.

“Initial balloon failure: 10.2%”

• Also stated in: § Additional information · plain

  “Initial balloon failure: 3.3%; P < 0.0001”

The quote only partly states this claim.

In Plante et al. (1994), procedure times were 81 +/-41 minutes in the reprocessed group versus 68 +/-32 minutes in the new device group, P<0.0001.

“Procedure times: 81 +/-41 minutes”

• Also stated in: § Additional information · plain

  “Procedure times: 68 +/-32 minutes, P < 0.0001”

May combine two claims.

In Plante et al. (1994), mean balloon catheter use per lesion was 2.4 +/-1.5 in the reprocessed group versus 1.2 +/-0.5 in the new device group, P<0.00001.

“Mean 2.4 +/-1.5 catheters”

• Also stated in: § Additional information · plain

  “Mean 1.2 +/-0.5 catheters”

May combine two claims.

In Plante et al. (1994), no statistically significant differences in clinical success and clinical failure without adverse events were reported between the 2 groups.

“No statistically significant differences in clinical success and clinical failure without adverse events were reported between the 2 groups.”

May combine two claims.

In Zacharias et al., because of flaws in study design, there is considerable likelihood of bias, confounding, and lack of generalizability, limiting confidence in the reported results.

“Because of the flaws in the study design there is considerable likelihood of bias, confounding, and lack of generalizability, limiting confidence in the reported results.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Leung et al. conducted a well-reported prospective cohort study with historical controls.

“Leung et al. 2 conducted a well-reported prospective cohort study with historical controls.”

• cites [2]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

In Browne et al., it is not described whether participants were consecutive or whether potential participants might have been excluded, limiting generalizability and validity.

“The included participants were selected from the same hospital, but it is not described whether they are consecutive, or whether any potential participants might have been excluded, limiting the generalizability and validity of the study results.”

May combine two claims.

In Jokar et al., adverse events were largely determined through patient self-report, which may not be as objective as if assessed by a health care professional using a validated outcome measure.

“Though adverse events were reported, they were largely determined through patient self-report (which may not be as objective as if assessed by a health care professional using a validated outcome measure).”

Probably not a substantial claim: may not pass S3 (load-bearing).

Included publications were critically appraised by 1 reviewer using the Downs and Black checklist for randomized and nonrandomized studies as a guide.

“The included publications were critically appraised by 1 reviewer using the Downs and Black checklist 13 for randomized and nonrandomized studies as a guide.”

• cites [13]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

The Browne et al. prospective cohort study with historical controls demonstrated serious reporting issues and external and internal validity issues.

“The Browne et al. 15 prospective cohort study with historical controls demonstrated serious reporting issues, external and internal validity issues.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Jokar et al. conducted a well-reported prospective cohort study evaluating the incidence of port-site infections in patients undergoing laparoscopic cholecystectomy.

“Jokar et al.21 conducted a well-reported prospective cohort study evaluating the incidence of PSIs in patients undergoing laparoscopic cholecystectomy.”

• cites [21]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim. May combine two claims.

It is unclear whether patient risk levels would be different for semicritical devices or in nonsurgical settings.

“All included studies evaluated SUMDs classified as critical, and all were conducted in surgical settings; however, it is unclear whether patient risk levels would be different for semicritical devices or in nonsurgical settings.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Marins et al. conducted a well-reported prospective cohort study evaluating surgical scissors and suture machines.

“Marins et al. 22 conducted a well-reported prospective cohort study evaluating surgical scissors and suture machines.”

• cites [22]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Health Canada regulates third-party device reprocessors and requires they meet the same requirements as new device manufacturers.

“In 2016, Health Canada updated its policy on the purchase and use of reprocessed SUMDs, concluding that it has authority to require that commercially reprocessed devices meet appropriate standards for safety, effectiveness, and labelling, with third-party reprocessing companies held to the same requirements as manufacturers of new devices.6”

• cites [6]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim. May combine two claims.

Overall, the Plante et al. study was well-reported but demonstrates issues with external and internal validity, particularly confounding.

“Overall, the Plante et al. 17 study was well-reported, but demonstrates issues with external validity and internal validity, particularly confounding.”

• cites [17]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

The Zacharias et al. study demonstrated issues with reporting, external validity, and internal validity.

“The study demonstrated issues with reporting, external validity, and internal validity.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Summary scores were not calculated for included studies; strengths and limitations of each included publication were described narratively.

“Summary scores were not calculated for the included studies; rather, the strengths and limitations of each included publication were described narratively.”

Probably not a substantial claim: may not pass S3 (load-bearing).

In Jokar et al., quasi-randomized allocation to treatment groups (odd/even patient ID) may have limited bias to some extent.

“They did report quasi-randomized allocation to treatment groups (if the last digit of the ID patient was odd, the patient was selected for the disposable port group, and if it was even, the patient was selected for the reprocessed port group), which may have limited bias to some extent.”

May combine two claims.

In Leung et al., because historical controls were used, treatment groups were not recruited over the same period, so differences between patients, providers, or other factors may have impacted observed outcomes.

“Also, as the study used historical controls, the treatment groups were not recruited over the same period, which means there could be differences between patients, providers, or other factors that may have impacted the observed outcomes.”

May combine two claims.

There are potential economic and environmental benefits of using reprocessed single-use medical devices.

“Given the potential economic and environmental benefits of using reprocessed SUMDs, [9][10][11][12] yet limited guidance for hospitals to pursue onsite SUMD reprocessing, there is a growing interest in determining the clinical safety of reprocessed SUMDs.”

• cites [9]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [10]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [11]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

A 2019 position statement for community health care settings published by Infection Prevention and Control Canada states that critical and semicritical medical equipment/devices labelled as single-use must not be reprocessed and reused unless a licensed reprocessor does the reprocessing.

“Therefore, a 2019 position statement for community health care settings published by Infection Prevention and Control Canada, states that critical and semicritical medical equipment/devices labelled as single-use must not be reprocessed and reused unless a licensed reprocessor does the reprocessing.23”

• cites [23]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

The reuse of SUMDs also has important potential economic and environmental benefits, which have been evaluated elsewhere.

“The reuse of SUMDs also has important potential economic and environmental benefits, which have been evaluated elsewhere.[9][10][11][12]”

• cites [9]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [10]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [11]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

The subjects in Browne et al. (1997) appeared representative of the population from which they were recruited.

“The subjects asked to participate in the study appeared to be representative of the entire population from which they were recruited”

May combine two claims.

Of the 8 included studies, 4 [15][16][17][18] were published before 2005, which potentially limits the applicability of at least half of the studies reported.

“In fact, of the 8 included studies,4 [15][16][17][18] were published before the year 2005, which potentially limits the applicability of at least half of the studies reported.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [16]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [17]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

The objective of the study by Browne et al. (1997) is clearly described.

“The objective of the study is clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing).

Browne et al. (1997) was powered to detect balloon failure rates.

“The study was powered to detect balloon failure rates”

Probably not a substantial claim: may not pass S3 (load-bearing).

No power calculation was described in Colak et al. 16.

“No power calculation was described”

• cites [16]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

The Gundogdu et al. 18 study demonstrated serious issues with reporting, external validity, and internal validity (bias and confounding).

“The study demonstrated serious issues with reporting and external validity, and internal validity, with regards to bias and confounding.”

• cites [18]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Estimates of random variability for the main outcomes and important adverse events are provided in Browne et al. (1997).

“Estimates of the random variability in the data for the main outcomes are provided, and important adverse events have been reported”

Probably not a substantial claim: may not pass S3 (load-bearing).

Loss to follow-up was not reported in Browne et al. (1997).

“Loss to follow-up was not reported”

May combine two claims.

The study conducted in Canada was published in 1994, and it is unknown if the same surgical methods, device specifications, patient care protocols, and reprocessing standards would be relevant today.

“In addition, the study conducted in Canada was published in 1994, and it is unknown if the same surgical methods, device specifications, patient care protocols, and reprocessing standards would be relevant today.”

• cites [17]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In Colak et al. 16, it is not known if blinding of outcome assessors occurred, though patients and surgeons were blinded.

“it is not known if blinding of outcome assessors occurred, though patients and surgeons were blinded.”

• cites [16]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

The characteristics of the patient group in Browne et al. (1997) are not clearly described.

“The characteristics of the patient group are not clearly described.While we know the source, no inclusion/exclusion criteria are reported.”

May combine two claims.

There is just 1 study conducted in Canada (Plante et al. 17), and results of studies conducted in other countries may not be generalizable to Canadian populations and settings.

“There is just 1 study conducted in Canada, 17, and the results of the studies conducted in the other countries may not be generalizable to Canadian populations and settings.”

• cites [17]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

The Colak et al. 16 RCT was well-reported and scored very well on external validity and internal validity (bias and confounding).

“The RCT was well-reported, and scored very well with regard to external validity, and internal validity, both bias and confounding”

• cites [16]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

While 8 studies met the inclusion criteria, they mostly looked at different devices for different interventions, which limits the amount of evidence available to evaluate patient outcomes for a specific device/intervention.

“While 8 studies met the inclusion criteria in this Rapid Review, they mostly looked at different devices for different interventions, which limits the amount of evidence available to evaluate the patient outcomes for a specific device/intervention.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

The staff, places, and facilities in Browne et al. (1997) appeared representative of the treatment the majority of patients receive.

“It appears that the staff, places, and facilities where the patients were treated were representative of the treatment the majority of patients receive”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The Canadian Standards Association has published a 2023 standard regarding Canadian medical device reprocessing for all health care settings (CSA Z314:23), superseding an earlier version published in 2018, but excludes reprocessing of SUMDs.

“The Canadian Standards Association has published a 2023 standard regarding Canadian medical device reprocessing for all health care settings (CSA Z314:23), superseding an earlier version published in 2018, but excludes reprocessing of SUMDs.24”

• cites [24]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

P values were not reported for any outcomes in Browne et al. 15.

“P values were not reported for any outcomes.”

• cites [15]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Classified as probably not a substantial claim. May combine two claims.

Reported outcomes such as procedure duration, fluoroscopy duration, and device failure would likely have some impact on patient outcomes, but it was not always clear what these impacts might be.

“For example, reported outcomes such as procedure duration, fluoroscopy duration, and device failure would likely have some impact on patient outcomes, but it was not always clear what these impacts might be.”

May combine two claims.

The majority of studies employed an in-house reprocessing protocol, and not the presumably more rigorous third-party reprocessing protocol, which has the potential to impact study results.

“Finally, the majority of the studies employed an in-house reprocessing protocol, and not the presumably more rigorous third-party reprocessing protocol, which has the potential to impact study results.”

• AssumptionRests on an assumption: Third-party reprocessing protocols are more rigorous than in-house reprocessing protocols.

Probably not a substantial claim: may not pass S3 (load-bearing).

The intervention and comparator in Browne et al. (1997) are described.

“The intervention and comparator are described”

Probably not a substantial claim: may not pass S3 (load-bearing).

Follow-up was the same for all patients in Browne et al. (1997).

“Follow-up was the same for all patients”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In 2018, the FDA reviewed and officially reported on the remanufacturing industry over the previous 2 decades and found no evidence that using remanufactured devices increased risk to health.

“In 2018, the FDA (FDA) reviewed and officially reported on the remanufacturing industry over the previous 2 decades and found no evidence that using remanufactured devices increased risk to health. 2”

• cites [2]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

P values were not reported in Browne et al. (1997).

“P values were not reported”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Outcomes in Browne et al. (1997) are not presented clearly, and many outcomes were not detailed in the introduction or methods.

“Outcomes are not presented clearly, and many outcomes are presented which were not detailed in the introduction or methods”

Probably not a substantial claim: may not pass S3 (load-bearing).

The Medicines and Health care Products Regulatory Agency also permits remanufacturing single-use devices within strict guidelines.

“The Medicines and Health care Products Regulatory Agency also permits remanufacturing single-use devices within strict guidelines.25”

• cites [25]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Only some of the outcomes are described in the introduction/methods of Browne et al. (1997).

“Only some of the outcomes are described in the introduction/methods”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

There is no description of the characteristics of the retrospective control group in Browne et al. (1997), so the distribution of potential confounders is unknown.

“There is no description of the characteristics of the retrospective control group, though it is described as being case-matched, and therefore the distribution of potential confounders is unknown”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The proportion of study participants that agreed to participate is not stated in Browne et al. (1997), nor is it known for the comparator group.

“The proportion of study participants that agreed to participate is not stated, nor is this known for the comparator group”

Probably not a substantial claim: may not pass S3 (load-bearing).

The outcome measures in Browne et al. (1997) appeared valid and reliable.

“Outcome measures appeared to be valid and reliable”

May combine two claims.

It is likely that device specifications, reprocessing protocols, and surgical approaches and patient care protocols have changed since some of these studies were published.

“It is likely that device specifications, reprocessing protocols, and surgical approaches and patient care protocols have changed since some of these studies were published.”

May combine two claims.

Most of the published evidence was of very low to moderate quality, published in countries outside Canada, with at least half published before 2005, which raises concerns regarding generalizability and applicability.

“In addition, most of the published evidence was of very low to moderate quality, and published in countries outside of Canada, with at least half of the evidence published before 2005, which raises concerns regarding generalizability and applicability.”

May combine two claims.

The Colak et al. 16 RCT was published in 2004, conducted in Turkey, and evaluates SUMDs reprocessed using an in-hospital protocol, which could limit its generalizability to the Canadian population and Canadian health care settings, as well as settings where third-party reprocessing is utilized.

“However, the RCT was published in 2004, was conducted in Turkey, and evaluates SUMDs that were reprocessed using an in-hospital protocol, which could limit its generalizability to the Canadian population and Canadian health care settings, as well as setting where third-party reprocessing is utilized.”

• cites [16]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

In Colak et al. 16, the proportion of patients that agreed to participate was not stated.

“The only issues noted were that the proportion of patients that agreed to participate in the study was not stated”

• cites [16]Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

The statistical tests in Browne et al. (1997) seemed appropriate.

“The statistical tests seemed appropriate”

Probably not a substantial claim: may not pass S3 (load-bearing).

Study objectives of Marins et al. (2018) were clearly described.

“Study objectives were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

It is not stated whether any adjustment was made for confounding in Zacharias et al. (2021), and potential confounders are not described.

“It is not stated whether any adjustment was made for confounding, and potential confounders at not described”

Probably not a substantial claim: may not pass S3 (load-bearing).

Follow-up was the same between groups in Colak et al. (2004).

“Follow-up was the same between groups”

Probably not a substantial claim: may not pass S3 (load-bearing).

It is not known if blinding of outcome assessors occurred in Colak et al. (2004).

“It is not known if blinding of outcome assessors occurred”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

Characteristics of the patients included in Colak et al. (2004) were clearly described.

“Characteristics of the patients included in the study were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing).

No power calculation was described in Plante et al. (1994).

“No power calculation was described”

Probably not a substantial claim: may not pass S3 (load-bearing).

There were confounders between treatment groups in Plante et al. (1994) that may not have been considered in the analysis, such as higher rates of unstable angina in the reprocessed group at baseline.

“There were confounders between treatment groups that may not have been considered in the analysis (i.e., higher rates of unstable angina in the reprocessed group at baseline)”

Probably not a substantial claim: may not pass S3 (load-bearing).

Study objectives of Jokar et al. (2022) were clearly described.

“Study objectives were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing).

No unplanned analyses occurred in Jokar et al. (2022).

“No unplanned analyses occurred”

Probably not a substantial claim: may not pass S3 (load-bearing).

Both groups in Jokar et al. (2022) were recruited over the same period of time.

“Both groups were recruited over the same period of time”

Probably not a substantial claim: may not pass S3 (load-bearing).

Loss to follow-up was not reported in Leung et al. (2019).

“Loss to follow-up was not reported”

Probably not a substantial claim: may not pass S3 (load-bearing).

No unplanned analyses occurred in Colak et al. (2004).

“No unplanned analyses occurred”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

All important adverse events appear to have been reported in Plante et al. (1994).

“It appears that all-important adverse events have been reported”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Both groups in Leung et al. (2019) were not recruited over the same period of time.

“Both groups were not recruited over the same period of time”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Main outcome measures used in Colak et al. (2004) were valid and appropriate.

“Main outcome measures used were valid and appropriate”

Probably not a substantial claim: may not pass S3 (load-bearing).

There does not appear to be any adjustment for confounding in Browne et al. (1997) since potential confounders are not described.

“There does not appear to be any adjustment for confounding since potential confounders are not described”

Probably not a substantial claim: may not pass S3 (load-bearing).

Blinding of outcome assessors was not described in Leung et al. (2019).

“Blinding of outcome assessors was not described”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

The statistical tests used to assess the main outcomes in Jokar et al. (2022) appeared appropriate.

“The statistical tests used to assess the main outcomes appeared to be appropriate”

Probably not a substantial claim: may not pass S3 (load-bearing).

The interventions of interest in Jokar et al. (2022) were clearly described.

“The interventions of interest were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing).

Follow-up was the same between groups in Leung et al. (2019).

“Follow-up was the same between groups”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

The interventions of interest in Colak et al. (2004) were clearly described.

“The interventions of interest were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing).

The distributions of principal confounders in each group of Jokar et al. (2022) were clearly described.

“The distributions of principal confounders in each group of subjects to be compared were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing).

Only 3 patients appeared to be lost to follow-up in Jokar et al. (2022).

“Only 3 patients appeared to be lost to follow-up”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

The main findings of Colak et al. (2004) were clearly described.

“The main findings of the study were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing).

The subjects in Jokar et al. (2022) seemed representative of the population from which they were recruited, given any patient requiring LC was eligible.

“The subjects asked to participate in the study seemed to be representative of the entire population from which they were recruited, given any patient requiring LC was eligible (excepting detailed inclusion and exclusion criteria)”

Probably not a substantial claim: may not pass S3 (load-bearing).

The outcome measures in Jokar et al. (2022) were clearly described.

“The outcome measures were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing).

Blinding of patients to treatment allocation occurred in Colak et al. (2004).

“Blinding of patients to treatment allocation occurred”

Probably not a substantial claim: may not pass S3 (load-bearing).

Study objectives of Leung et al. (2019) were clearly described.

“Study objectives were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing).

No power calculation was described in Zacharias et al. (2021).

“No power calculation was described”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

All important adverse events that may be a consequence of the intervention were reported in Colak et al. (2004).

“All important adverse events that may be a consequence of the intervention were reported”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Outcomes of Leung et al. (2019) were clearly described.

“Outcomes were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing).

It is not known if patients and outcome assessors were blinded to treatment assignment in Browne et al. (1997).

“It is not known if patients and outcome assessors were blinded to treatment assignment”

Probably not a substantial claim: may not pass S3 (load-bearing).

Statistical analysis in Leung et al. (2019) was appropriate.

“Statistical analysis was appropriate”

Probably not a substantial claim: may not pass S3 (load-bearing).

A very simple power calculation was performed in Jokar et al. (2022).

“A very simple power calculation was performed”

Probably not a substantial claim: may not pass S3 (load-bearing).

The proportion of those asked who agreed to participate in Leung et al. (2019) was not stated.

“The proportion of those asked who agreed to participate in the study was not stated.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Actual P values were reported in Plante et al. (1994).

“Actual P values were reported”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

The staff, places, and facilities in Colak et al. (2004) seemed representative of the treatment the majority of similar patients would receive.

“The staff, places, and facilities where the patients were treated seemed to be representative of the treatment the majority of similar patients would receive”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

The main findings of Jokar et al. (2022) were clearly described.

“The main findings of the study were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing).

No power calculation was described in Colak et al. (2004).

“No power calculation was described”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

The statistical analyses in Plante et al. (1994) seemed appropriate.

“Statistical analyses seemed to be appropriate”

May combine two claims.

Adverse events in Jokar et al. (2022) were largely determined through patient self-report, and follow-up may not have been sufficiently long-term to assess all adverse events.

“Though adverse events were reported, they were largely determined through patient self-report which is not ideal, and follow-up may not have been sufficiently long-term to assess all adverse events”

May combine two claims.

The randomized intervention assignment in Jokar et al. (2022) was not described as being concealed from patients and would not likely be concealed for health care staff.

“The randomized intervention assignment was not described as being concealed from patients and would not likely be concealed for health care staff”

Probably not a substantial claim: may not pass S3 (load-bearing).

No power calculation was described in Leung et al. (2019).

“No power calculation was described”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

The distributions of principal confounders in each group of Colak et al. (2004) were clearly described.

“The distributions of principal confounders in each group of subjects to be compared were clearly described”

May combine two claims.

Patients in Leung et al. (2019) were not randomized to treatment groups and allocation concealment was not implemented.

“Patients were not randomized to treatment groups and allocation concealment was not implemented”

Probably not a substantial claim: may not pass S3 (load-bearing).

Both groups in Marins et al. (2018) were recruited over the same period of time.

“Both groups were recruited over the same period of time”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

The staff, places, and facilities in Plante et al. (1994) seemed representative of the treatment the majority of patients receive.

“It appears that the staff, places, and facilities where the patients were treated were representative of the treatment the majority of patients receive”

Probably not a substantial claim: may not pass S1 (asserted), S3 (load-bearing), S4 (based).

The distributions of principal confounders in each group of Leung et al. (2019) were clearly described.

“The distributions of principal confounders in each group of subjects to be compared were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing).

Jokar et al. (2022) does not provide estimates of the random variability in the data for the outcome.

“The study does not provide estimates of the random variability in the data for the outcome”

Probably not a substantial claim: may not pass S3 (load-bearing).

Quasi-randomization was performed to assign patients to each group in Jokar et al. (2022).

“Quasi-randomization was performed to assign patients to each group”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The objectives, main outcomes, interventions, and characteristics of included patients of Plante et al. (1994) were well-described.

“The objectives of the study, the main outcomes, description of the interventions, and the characteristics of the included patients were well-described”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Actual P values and estimates of random variability were reported in Leung et al. (2019).

“Actual P values were reported and estimates of random variability were reported”

Probably not a substantial claim: may not pass S3 (load-bearing).

There were no confounding factors between treatment groups at baseline in Leung et al. (2019).

“There were no confounding factors between treatment groups at baseline”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Both groups in Jokar et al. (2022) were recruited from the same population.

“Both groups were recruited from the same population”

Probably not a substantial claim: may not pass S3 (load-bearing).

No power calculation was reported in Marins et al. (2018).

“No power calculation was reported.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Length of follow-up was the same in both groups in Jokar et al. (2022).

“Length of follow-up was the same in both groups”

Probably not a substantial claim: may not pass S3 (load-bearing).

Patients in the different treatment groups in Plante et al. (1994) were recruited over the same period of time.

“Patients in the different treatment groups were recruited over the same period of time”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Outcomes of Colak et al. (2004) were clearly described.

“Outcomes were clearly described”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

The main findings of Leung et al. (2019) were clearly described.

“The main findings of the study were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

The proportion lost to follow-up in Colak et al. (2004) was too small to affect the main findings.

“The proportion lost to follow-up was too small to affect the main findings”

Probably not a substantial claim: may not pass S3 (load-bearing).

Both groups in Marins et al. (2018) were recruited from the same population.

“Both groups were recruited from the same population”

Probably not a substantial claim: may not pass S3 (load-bearing).

Characteristics of the patients included in Jokar et al. (2022) were clearly described.

“Characteristics of the patients included in the study were clearly described”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

Main outcome measures used in Leung et al. (2019) were valid and appropriate.

“Main outcome measures used were valid and appropriate”

Probably not a substantial claim: may not pass S3 (load-bearing).

No adjustment appeared to be made for different lengths of follow-up in Marins et al. (2018).

“No adjustment appeared to be made for different lengths of follow-up”

Probably not a substantial claim: may not pass S3 (load-bearing).

Statistical analysis in Colak et al. (2004) was appropriate.

“Statistical analysis was appropriate”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

All important adverse events that may be a consequence of the intervention were reported in Leung et al. (2019).

“All important adverse events that may be a consequence of the intervention were reported”

Probably not a substantial claim: may not pass S3 (load-bearing).

Both groups in Colak et al. (2004) were recruited over the same period of time.

“Both groups were recruited over the same period of time”

Probably not a substantial claim: may not pass S3 (load-bearing).

It is unknown if loss to follow-up occurred and was addressed in Zacharias et al. (2021).

“It is unknown if loss to follow-up occurred and was addressed if so”

Probably not a substantial claim: may not pass S3 (load-bearing).

Actual P values were reported in Jokar et al. (2022).

“Actual P values were reported”

May combine two claims.

Patients in Plante et al. (1994) were not randomized to intervention groups and randomization concealment did not occur.

“Patients were not randomized to intervention groups and randomization concealment did not occur”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Patients in Colak et al. (2004) were randomized to treatment groups and allocation concealment was implemented.

“Patients were randomized to treatment groups and allocation concealment was implemented (only the nurse knew the allocation)”

Probably not a substantial claim: may not pass S3 (load-bearing).

The proportion of those asked who agreed to participate was not provided in Plante et al. (1994).

“The proportion of those asked who agreed to participate was not provided”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Actual P values and estimates of random variability were reported in Colak et al. (2004).

“Actual P values were reported and estimates of random variability were reported”

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

The interventions of interest in Zacharias et al. (2021) are clearly described.

“The interventions of interest are clearly described”