Participant eligibility criteria | 2.17 (0.8) | 2 | -Restrictiveness of eligibility criteria -Representation of patient population -Reach of participant recruitment/referral sources
| -Few exclusion criteria aside from contraindications -Comorbidities, interventions, and pain medications allowed -Minimum age of 21, with no upper age limit -Patients referred from 41 different primary care providers from 18 different practice sites -Patients had to visit care provider during referral window
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Intervention flexibility | | | | |
MT | 3.33 (0.5) | 3 | | -MT provided by 26 CMPs in CMP practice environment. -CMPs developed individualized treatment plans per patient -CMPs free to use any technique within their scope of practice -Dose: up to 10 (typically 60-minute) MT treatments over 12 to 14 weeks with CMP/patient-determined schedule
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PMR | 1.83 (1.0) | 1.5 | -Participants asked to self-administer (listen to) daily recorded, 25- to 35-min PMR sessions via a programed PDA -No reminders or prompts by study personnel were used to trigger participants to administer PMR sessions
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Intervention practitioner expertise | | | | |
MT | 2.5 (1.0) | 2.5 | -Restrictions placed on experience level of intervention practitioners -Practitioners providing intervention experience and level of expertise -Number of providers used -The extent to which specialized training is required
| -CMPs holding Kentucky license in massage -No special technique training required for CMPs -Required CMP experience in MT ≥5 years -Participating CMPs had 5 to ≥30 years of experience with various expertise and training levels -All CMPs living in study areas invited to participate via mailed letters, personal calls, and/or in-person outreach activities
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PMR | 2.67 (1.4) | 3 | | -Recorded PMR protocol developed and performed by practitioner with >15 years of experience in relaxation techniques -PMR participants (asked to “self-administer” treatment) were given no training besides how to use the PDA to listen to PMR sessions -Printed outline of PMR script provided to PMR participants
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Follow-up intensity | 2.33 (1.0) | 2 | -Extent to which extra visits (besides those for usual care) are required by participants to follow-up -Length of follow-up time (too short may miss important/meaningful outcomes) -Extent to which participants are tracked down for follow-up
| -Follow-up visits for outcome data collection required outside of usual primary care -If patients could not come to the study site, personnel would mail or administer surveys in locations convenient to participant -Timing and frequency of data collection visits were prespecified in the study protocol, allowing for longer follow-up -Participants were contacted multiple times and through various means
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Primary trial outcome | 3 (0.6) | 3 | -The extent to which the primary outcome is of patient import and less focused on direct effect or biological responses -Measurement approach with regard to how collected (related to usual care), training needs to administer measurement, time horizons for collection
| -Primary trial outcomes were the Oswestry Disability Index and SF-36, which are both patient-centered, self-report, and highly focused on quality of life -Required collection outside of usual care -No special training or testing required for administration -Total follow-up duration was 12 and 24 weeks
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Participant compliance | | | | |
MT | 2.5 (1.6) | 3 | | -No efforts were made on the part of study personnel to facilitate or support the scheduling of massage treatment sessions -No efforts were made outside of usual massage practice to encourage or support participant compliance with scheduled treatment appointments -CMPs had and exercised the right to refuse continued service to MT patients who habitually missed scheduled appointments without notice; participation in the overall study was not affected in these instances
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PMR | 3.17 (1.0) | 3.5 | |
Practitioner adherence | | | | |
MT | 3 (1.1)/3 | 3 | | -No specific efforts or communications were made to CMPs regarding how to treat the participants in their care or implement trial treatments -Study personnel and massage liaison were available to advise CMPs regarding how to complete study paperwork on treatments used and standard SOAP notes -Study massage liaison reviewed submitted notes to monitor safety, documentation, and variations from standard massage practice
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PMR | 0 (0) | 0 | |
Analysis of the primary outcome | 3.67 (0.5) | 4 | -Extent to which restrictions are placed on the inclusion of data in the primary analysis, particularly the case when noncompliant or dropouts are excluded from the analysis, per protocol -The extent to which subgroup analyses are planned for those who are expected to have better treatment effects
| -Intent to treat analysis plan with no special allowances for (1) noncompliance (patient), (2) nonadherence (practitioner); (3) practice variability (CMP and PCP referral site) -Secondary analyses not specifically planned at time of study development; were performed upon completion of the study to inform future study design and hypothesis development
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