Table 1. Twelve Kentucky Pain and Research Outcomes Study (KYPROS) Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) Spokes, Scores and Component Description for Each Spoke, and the Applicable Aspects of KYPROS Methodology Considered by Respondents When Scoring
PRECIS Components and Related KYPROS SpokesScore*Component DescriptionRelevant KYPROS Characteristics
Mean (SD)Median
Participant eligibility criteria2.17 (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

Intervention flexibility
    MT3.33 (0.5)3
  • -Restrictions placed on intervention delivery

  • -Limitations on co-interventions

  • -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

    PMR1.83 (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

Intervention practitioner expertise
    MT2.5 (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

    PMR2.67 (1.4)3
  • -The extent to which targeted selection is based on prior performance and/or results regarding intervention

  • -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

Follow-up intensity2.33 (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

Primary trial outcome3 (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

Participant compliance
    MT2.5 (1.6)3
  • -Extent to which participants have agency to comply or not with trial treatment

  • -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

    PMR3.17 (1.0)3.5
  • -No efforts were made by study personnel to encourage or support participant compliance to the daily PMR dosing expectations

Practitioner adherence
    MT3 (1.1)/33
  • -Extent to which practitioners are free to exercise clinical judgment regarding application of trial treatment(s) as they would in usual care

  • -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

    PMR0 (0)0
  • -Used as an example for scoring because of the recorded nature of the treatment, inherently forcing adherence to the protocoled script; assigned a score of 0 by study personnel

Analysis of the primary outcome3.67 (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

  • * A higher score indicates a more pragmatic approach. Scores are reported as the mean (standard deviation) and median of 6 responders, with a range of 0–4.

  • As informed by the work of Thorpe and colleagues1 and Sackett.12

  • CMP, community massage practitioner; MT, massage therapy; PCP, primary care physician; PDA, personal digital assistant; PMR, progressive muscle relaxation; SD, standard deviation; SF-36, 36-item Short Form; SOAP, subjective, objective, assessment, plan.