Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study

May combine two claims.

For depression, many participants either did not know how to apply mindfulness or were unsure if it was effective.

“A notable exception was for those experiencing depression, in which case the message seemed to be that many either did not know how to apply mindfulness to address depression or if they did apply it, they were unsure if it was effective.”

May combine two claims.

Participants perceived benefits including increased calm and well-being, control over sad or negative emotions, impulse control, self-esteem, open-mindedness, and patience.

“The extent to which participants perceived M-ROCC as likely to achieve its purpose was exemplified by comments about perceived benefits including: increased feelings of calm and well-being, control over sad or negative emotions, impulse control, self-esteem, open-mindedness and patience.”

May combine two claims.

Some participants were hesitant to transition to the 2-hour MTPC-OUD groups due to schedule conflicts, inability to stay focused, and potential loss of interest.

“some were hesitant to transition to the 2-hour MTPC-OUD groups, citing schedule conflicts, ‘I work and go to school…just not sure if I could really fit that into my schedule right now’(08wk4), inability to stay focused, and potential loss of interest (09wk4) as reasons for not pursuing the more intensive group.”

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

Outliers suggested some participants may have been more motivated at the beginning or suggested the need for AA, NA or a sponsor.

“outliers suggested some may have been more motivated at the beginning, or suggested the need for AA, NA or a sponsor”

May combine two claims.

One participant experienced two serious adverse events (serial overdoses involving benzodiazepines and clonazepam) in the context of urine toxicology screen tampering, but neither overdose was related to the study or intervention.

“One participant experienced two serious adverse events, which were serial overdoses involving benzodiazepines and clonazepam in the context of urine toxicology screen tampering, but neither overdose was related to the study or the intervention.”

May combine two claims.

Over eight months of recruitment, providers referred 68 participants, and 25 provided informed consent.

“Over the course of eight months of recruitment, providers referred 68 participants, of whom 25 provided informed consent.”

May combine two claims.

Qualitative interviews were conducted at 4 weeks (n = 9) and 24 weeks (n = 7) with twelve unique participants (66% of the initial sample; 12/13 who completed the 24-week battery also completed a qualitative interview).

“The study team conducted qualitative interviews at 4-weeks (n = 9) and 24-weeks (n = 7) with twelve unique participants (66% of initial sample: 12/13 who completed the 24-week battery also completed a qualitative interview).”

May combine two claims.

Among those who began the intervention, 77.8% (n = 14) had more than two comorbid DSM-V diagnoses in addition to OUD, and 55.6% (n = 10) had an ACE score greater than 4.

“Of those who began the intervention, 77.8% (n = 14) had more than 2 comorbid DSM-V diagnoses in addition to OUD, and 55.6% (n = 10) had an ACE score greater than 4.”

May combine two claims.

The research team withdrew this participant due to ongoing urine tampering, need for a more intensive treatment program, and concern for safety.

“The research team withdrew this participant from the study due to their ongoing urine tampering, need for a more intensive treatment program, and concern for the patient’s safety.”

May combine two claims.

In a sample with high childhood trauma and comorbid psychiatric diagnoses, M-ROCC was feasible, with 89% retained at 4 weeks and 72% at 24 weeks.

“M-ROCC was feasible in a sample with high rates of childhood trauma and comorbid psychiatric diagnoses with 89% of participants retained at 4-weeks and 72% at 24-weeks.”

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

Participants who began the intervention averaged 47.4 years of age (SD = 12.8), and 94.4% (n = 17) were white.

“Participants who began the intervention were 47.4 years of age (SD = 12.8) on average and 94.4% (n = 17) were white.”

May combine two claims.

Overall ratings of the facilitator(s) (M = 4.8) and of the group (M = 4.8) were both high.

“Overall ratings of the facilitator(s) (M = 4.8) and of the group (M = 4.8) were both also high.”

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

A few participants spoke positively of rolling admissions in the LDM.

“A few participants spoke particularly positively of rolling admissions in the LDM”

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

A total of 16 interviews were conducted.

“Thus, there were a total of 16 interviews conducted.”

The quote only partly states this claim.

Changes in the FFMQ Observe subscale correlated most strongly with daily informal practice time.

“The changes in Observe (r = 0.67, p = 0.017) and Act with Awareness (r = 0.56, p = 0.045) FFMQ subscales correlated most strongly with daily informal practice time.”

May combine two claims.

Themes characterizing home practice included the optimal amount of time to practice, the optimal time of day to practice, and the most helpful practices.

“Themes characterizing home practice surfaced regarding the optimal amount of time to practice (see ‘the sweet spot’ referenced above), the optimal time of day to practice, and the most helpful practices.”

May combine two claims.

Participants derived energy, support, focus, and/or motivation from peers within the group setting.

“Individual M-ROCC participants derived energy, support, focus, and/or motivation from peers within the group setting, and explicitly recognized these benefits.”

May combine two claims.

The most helpful practices identified were the body scan, grounding mindfulness practices, and mindful movement.

“The most helpful practices identified across interviews were the body scan, grounding mindfulness practices (informal mindfulness of body sensations or 5 senses, e.g., touchpoints), and mindful movement.”

May combine two claims.

Positive qualitative interview responses and a 100% rate of willingness to refer a friend demonstrate program acceptability.

“Positive qualitative interview responses and a high rate of participants willing to refer a friend (100%) demonstrates program acceptability.”

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

The external qualitative methods expert interviewed four participants at both timepoints.

“The external qualitative methods expert interviewed four participants at both timepoints.”

May combine two claims.

Most participants offered examples of informal practice that spread into daily routines and were associated with confidence in performing new skills.

“Most participants also offered examples of informal practice that ‘spread out’ (14wk24) into their daily routines and were associated with assessments of confidence in their performance of new skills.”

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

Several participants had prior meditation experience, with an overall average of 10.5 minutes of daily meditation practice and 6/18 (33%) practicing for 10 minutes a day or more.

“Several participants reported a history of meditation experience, with an overall average of 10.5 minutes of daily meditation practice and with 6/18 (33%) participants practicing for 10 minutes a day or more.”

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

The study team completed eight Adverse Event Reports.

“The study team completed eight Adverse Event Reports.”

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

Seven participants did not complete screening and baseline measures and were not scheduled to begin the study.

“Seven participants did not complete screening and baseline measures, so were not scheduled to begin the study.”

May combine two claims.

None of the adverse events were related to the protocol and six were non-serious.

“Of these, none were related to the protocol and six were non-serious.”

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

Of those enrolled, 17 came from the Somerville site and 8 from the Revere site.

“Of those enrolled, 17 enrolled from the Somerville site, and 8 enrolled from the Revere site.”

The quote only partly states this claim.

Changes in the FFMQ Act with Awareness subscale correlated most strongly with daily informal practice time.

“The changes in Observe (r = 0.67, p = 0.017) and Act with Awareness (r = 0.56, p = 0.045) FFMQ subscales correlated most strongly with daily informal practice time.”

May combine two claims.

Among those who completed a satisfaction survey, 100% (n = 16) agreed they would recommend the program to a friend (M for 4-week LDM (n = 16) = 4.9, M for 24-week M-ROCC (n = 13) = 5.0).

“Among those who completed a satisfaction survey, 100% (n = 16) of respondents agreed that they would recommend the program to a friend (M for 4-week LDM (n = 16) = 4.9, M for 24-week M-ROCC (n = 13) = 5.0).”

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

Five of the six participants who declined the interview invitation had not completed the intervention.

“It is important to note that five out of the six participants who declined the interview invitation were participants who did not complete the intervention”

May combine two claims.

Participants deemed home practice the most challenging component, but qualitative findings offer understanding of challenges and ability to overcome them, which all but one interviewed participant described.

“Although participants deemed home practice to be the most challenging component of the M-ROCC intervention, the qualitative findings offer much greater understanding of these challenges, as well as the participants’ ability to overcome them, which all but one of the interviewed participants described.”

May combine two claims.

M-ROCC participants found these group variables to be on a continuum from neutral (gender) to favorable (pace, rolling admission, commitment matching), potentially supporting the noted high retention.

“However, M-ROCC participants found these group variables to be on a continuum from neutral (gender) to favorable (pace, rolling admission, commitment matching), potentially supporting the noted high retention.”

May combine two claims.

Most of those who completed the 8-week 2-hour per week MTPC-OUD intensive program at one site found the format particularly impactful and logistically feasible; another site required a 16-week model of 1-hour groups for logistical feasibility, which participants found more accessible.

“Finally, most of those who completed the 8-week 2-hour per week MTPC-OUD intensive program at one site found the format particularly impactful and logistically feasible; while another primary care site required a 16-week model of 1-hour groups for clinician and site administrative logistical feasibility, which participants at that site also found to be more accessible.”

May combine two claims.

Participants found the intervention acceptable in terms of flexibility of transition between groups and ability to identify optimal amount of formal practice at home.

“Participants also found the intervention to be acceptable in terms of the flexibility of both the transition between different levels of groups (LDM, MTPC-OUD, and MCS) and their ability to identify the optimal amount of formal practice they could complete at home.”

May combine two claims.

Participants found the intervention acceptable, allowing them to integrate the practices into their lives in meaningful ways.

“Importantly, participants found the intervention to be acceptable, allowing them to integrate the practices into their lives in meaningful ways.”

May combine two claims.

Extended buprenorphine/naloxone treatment raises abstinence and retention rates and lowers the risk of transmitting hepatitis C.

“Extended treatment with B/N not only increases rates of abstinence and treatment retention, but also decreases risk of transmitting Hepatitis C (HCV) (Hallinan et al., 2005; Weiss et al., 2012).”

• cites Hallinan et al., 2005 sourceNot checked yet

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• cites Weiss et al., 2012Not checked yet

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May combine two claims.

People with childhood trauma often struggle to manage emotions around those events, which fosters experiential avoidance and can lead some to abandon mindfulness practice when difficult emotions arise.

“People with childhood traumatic experiences often have trouble managing their emotions around these events, which fosters experiential avoidance and leads some to abandon their mindfulness practice when difficult emotions arise (Banerjee et al., 2017; Lindahl et al., 2017; Lomas et al., 2015; Van Dam et al., 2018; Wyatt et al., 2014).”

• cites Banerjee et al., 2017 sourceNot checked yet

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• cites Lindahl et al., 2017Not checked yet

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• cites Lomas et al., 2015 sourceNot checked yet

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May combine two claims.

Many participants in mindfulness-based interventions struggle to meet home practice requirements of about 30-45 minutes daily and say they lack time to fit practice into their routines.

“Many participants experience difficulty meeting practice requirements (around 30–45 minutes per day), and report that they lack the time to integrate mindfulness practice into their daily routines (Dobkin et al., 2012; Kabat-Zinn et al., 2017; Lomas et al., 2015; Wyatt et al., 2014).”

• cites Dobkin et al., 2012 sourceNot checked yet

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• cites Kabat-Zinn et al., 2017Not checked yet

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• cites Lomas et al., 2015 sourceNot checked yet

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May combine two claims.

One site delivered MTPC-OUD in 8 weeks and another in 16 weeks, showing that M-ROCC has the flexibility needed for feasible implementation in diverse primary care clinics.

“In the present study, one site implemented MTPC-OUD in an 8-week format, while another chose a 16-week format, demonstrating that M-ROCC has the necessary flexibility as designed for feasible implementation in diverse primary care clinic environments.”

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

There were very few disagreements between coders about which text to code or how to code it.

“When comparing our respective coding of transcripts, there were very few disagreements about either relevant text to be coded or how to code relevant text.”

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

To prevent bias during analysis, a statistical consultant conducted the analysis in STATA.

“To prevent bias during analysis, a statistical consultant (TC) conducted the analysis in STATA.”

May combine two claims.

The high retention points towards intervention feasibility and the need for larger samples to study whether mindfulness training might enhance treatment retention.

“This optimistic finding points towards intervention feasibility and the need for larger samples to study whether mindfulness training might enhance treatment retention.”

May combine two claims.

People with OUD have high rates of childhood abuse and psychological trauma and may be especially prone to dropout.

“People with OUD have high rates of childhood abuse and psychological trauma, and may be particularly susceptible to dropout (Ecker & Hundt, 2018; Stein et al., 2017).”

• cites Ecker & Hundt, 2018Not checked yet

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• cites Stein et al., 2017 sourceNot checked yet

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

An independent data safety monitoring board reviewed adverse event reports.

“An independent data safety monitoring board reviewed AERs.”

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

The study had a NCCIH-approved data safety monitoring plan with an independent monitoring committee, was approved by the hospital IRB, and was listed on ClinicalTrials.gov (NCT03798431).

“This study had a NCCIH-approved data safety monitoring plan with an independent monitoring committee, was approved by the hospital Institutional Review Board and was listed on ClinicalTrials.gov (NCT03798431).”

Classified as probably not a substantial claim.

To prevent bias, an external qualitative methods expert unaffiliated with CMC and not trained in mindfulness-based interventions conducted and oversaw the qualitative interview analysis.

“To prevent bias, an external qualitative methods expert (SM) with experience in OUD qualitative studies, who was unaffiliated with CMC and had not been trained to deliver mindfulness-based interventions, conducted and oversaw analysis for qualitative interviews.”

May combine two claims.

Between 47% and 90% of women aged 15-44 with a substance use disorder have experienced interpersonal violence, compared with 1-20% in non-SUD populations, and about 10% of men with a SUD have experienced IPV in their lifetime.

“Furthermore, between 47% and 90% of women (15–44 years) with a SUD have experienced interpersonal violence (IPV) compared with 1–20% in non-SUD populations, and approximately 10% of men with a SUD have been victims of IPV across their lifetime (Klostermann, 2006; Lipsky et al., 2005; Schneider et al., 2009).”

• cites Klostermann, 2006Not checked yet

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• cites Lipsky et al., 2005 sourceNot checked yet

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• cites Schneider et al., 2009 sourceNot checked yet

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

An experienced qualitative methods expert and a qualitative methodologist trainee independently reviewed all transcripts.

“An experienced qualitative methods expert (SM) and a qualitative methodologist trainee (KO) independently reviewed all transcripts.”

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

After reviewing the second batch, both analysts independently coded the third batch with the revised codebook to assess coder agreement, which was readily achieved.

“Following review of the second batch, both analysts independently coded the third batch using the revised codebook to assess agreement between coders, which was readily achieved.”

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

Social desirability bias may have influenced participant reports of home practice as well as other aspects of the qualitative interviews.

“Even though the interviewer was not related to the intervention in any way, social desirability bias may have influenced participant reports of home practice as well as other aspects of the qualitative interviews.”

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

A recent systematic review and meta-analysis suggests that in standard format MBCT and MBSR, participants complete about 60% of assigned formal home practice.

“A recent systematic review and meta-analysis suggests that in standard format MBCT and MBSR, participants complete about 60% of assigned formal home practice, where it is recorded and reported (Parsons et al., 2017).”

• cites Parsons et al., 2017 sourceNot checked yet

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May combine two claims.

MTPC focuses more heavily on stress, anxiety, craving and behavior change in contrast to MBCT, which was designed specifically to target depression.

“likely because MTPC focuses more heavily on stress, anxiety, craving and behavior change in contrast to MBCT, which researchers designed specifically to target depression (Teasdale et al., 2000).”

• cites Teasdale et al., 2000 sourceNot checked yet

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May combine two claims.

These findings demonstrate that the M-ROCC intervention can feasibly be integrated into a primary care OBOT setting in a way that is acceptable to the target population.

“These findings demonstrate that the M-ROCC intervention can feasibly be integrated into a primary care OBOT setting in a way that is acceptable to the target population.”

May combine two claims.

Though the demographics of those enrolled in the healthcare system's primary care OBOT programs are similarly imbalanced, this still limits generalizability.

“Though the demographics of those enrolled in the healthcare system’s primary care OBOT programs are similarly imbalanced, this still limits generalizability.”

May combine two claims.

This flexibility aligns with a trauma-informed approach and a patient-centered motivational interviewing approach, creating a therapeutic alliance with participants.

“This flexibility aligns with both a trauma-informed approach ensuring choice and a patient-centered, evidence-based motivational interviewing [MI] approach to behavior change, which empowers the patient to develop his or her own motivation. It also creates a therapeutic alliance with participants - a partnership and collaboration rather than an expert/patient dynamic (Rollnick & Miller, 1995; Vanb”

• cites Rollnick & Miller, 1995Not checked yet

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• cites Vanbuskirk & Wetherell, 2014Not checked yet

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May combine two claims.

Current research suggests that men may benefit from MBIs less than women, and that men are less likely to engage in and acknowledge the helpfulness of psychotherapies such as MBIs.

“Current research suggests that men may benefit from MBIs less than women, and that men are less likely to engage in and acknowledge the helpfulness of psychotherapies such as MBIs (Addis & Mahalik, 2003; Pattyn et al., 2015; Rojiani et al., 2017).”

• cites Addis & Mahalik, 2003 sourceNot checked yet

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• cites Pattyn et al., 2015 sourceNot checked yet

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• cites Rojiani et al., 2017Not checked yet

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

The different settings, populations, and primary care teams may have influenced the effectiveness of the M-ROCC curriculum at each site.

“The different settings, populations, and primary care teams may have influenced the effectiveness of the M-ROCC curriculum at each site.”

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

Home practice is one of the most essential components in MBIs to increase the therapeutic effects of the treatment.

“Home practice is one of the most essential components in MBIs to increase the therapeutic effects of the treatment (Vettese et al., 2009).”

• cites Vettese et al., 2009 sourceNot checked yet

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

Childhood trauma is correlated with IPV among men.

“is also correlated with IPV among men (Godbout et al., 2019).”

• cites Godbout et al., 2019 sourceNot checked yet

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Classified as probably not a substantial claim.

A larger sample is necessary to sufficiently power the quantitative results, specifically regarding the effectiveness of the intervention.

“A larger sample is necessary to sufficiently power the quantitative results, specifically regarding the effectiveness of the intervention (Billingham et al., 2013).”

• cites Billingham et al., 2013Not checked yet

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May combine two claims.

This approach encourages retention in B/N treatment and allows participants to continue learning mindfulness skills beyond the standard 8-week MBI endpoint.

“Not only does this approach encourage retention in B/N treatment, but it also allows participants to continue to learn mindfulness skills beyond the standard 8-week MBI endpoint.”

May combine two claims.

Approximately 60-70% of those who enroll in standard opioid treatment programs are men, while in most MBI groups in the community for non-OUD populations only 30-40% of those who enroll are men.

“Approximately 60–70% of those who enroll in standard opioid treatment programs are men; and yet, in most MBI groups in the community for non-OUD populations only 30–40% of those who enroll are men (Fiellin et al., 2013; Lomas et al., 2019; Waldron et al., 2018; Weiss et al., 2012).”

• cites Fiellin et al., 2013Not checked yet

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• cites Lomas et al., 2019 sourceNot checked yet

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• cites Waldron et al., 2018 sourceNot checked yet

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

Those who did not complete the intervention may have possibly been more critical of M-ROCC.

“Those who did not complete the intervention may have possibly been more critical of M-ROCC.”

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

As many as 50% of men in SUD treatment have perpetrated IPV in the previous year, and greater SUD severity can predict partner and non-partner violence.

“As many as 50% of men in SUD treatment have perpetrated IPV in the previous year, and greater SUD severity can predict partner and non-partner violence (Chermack et al., 2000; Gondolf, 1999).”

• cites Chermack et al., 2000Not checked yet

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• cites Gondolf, 1999 sourceNot checked yet

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

Body scanning and grounding with mindfulness are fundamentally attuned to restructuring sensory experience and one's relationship with body sensations.

“Both body scanning and grounding with mindfulness are fundamentally attuned to restructuring sensory experience and one’s relationship with body sensations.”

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

This amount equates to around 30 minutes per day, six days a week, and this substantial time commitment represents a barrier to novice meditators.

“This amount equates to around 30 minutes per day, six days a week and this substantial time commitment represents a barrier to novice meditators (Chen et al., 2014).”

• cites Chen et al., 2014 sourceNot checked yet

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

The finding that informal practice correlates with trait mindfulness is notable because informal practice may be easier for people in early recovery to integrate into their lives.

“This finding is notable because informal practice may be easier for people in early recovery to integrate into their lives.”

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

Participants' previous mindfulness experience may have contributed to high retention rates and willingness to engage in practice.

“Participant’s previous mindfulness experience may also have contributed to this study’s high retention rates and participant willingness to engage in practice.”

May combine two claims.

We were unable to interview participants who did not complete the M-ROCC intervention, resulting in a selection bias that potentially skewed the results in an overly positive direction.

“In terms of the qualitative methods, we were unable to interview participants who did not complete the M-ROCC intervention, resulting in a selection bias that potentially skewed the results in an overly positive direction.”

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

During recruitment, referring clinicians informed participants they would be participating in a MBI, which may have biased those who decided to join towards reporting high satisfaction.

“During recruitment, referring clinicians informed participants that they would be participating in a MBI, which may have biased those who decided to join towards reporting high satisfaction.”