Alamo 2002.
| Methods |
Randomization procedure: By practice/clinic Informed consent obtained: Yes Protection against contamination: Inadequate. Individual randomisation of providers with some working in the same practice. Some transfer of patients between intervention and control group Outcomes assessors blinded: Adequate: Video tape coder was blinded to provider status. Telephone interviewer was blinded to patient status Intention to treat analysis: Done Potential for unit of analysis error: Primary outcome (patient survey) randomisation by provider practice, but analysis by patient without concern for confounding. The problem was partly acknowledged Comments on study quality: None to add |
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| Participants |
Profession: Medicine Specialty: General Practice/Family physicians Years experience: Intervention M (SE) 9.7 (1.7) Control 9.2 (1.4) Clinical setting: Health Centers Level of Care: Primary Country: Spain Health problem/Type of Patient: Musculoskeletal chronic pain/ fibromyalgia. Mean age = 44.4 years, 97.3% female, 88.2% married, 54.4% housewives |
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| Interventions |
Aim of study (hypothesis): To assess whether patient‐centred consultations are more effective than the usual style of consultation used by experienced general practitioners with patients suffering from benign chronic musculoskeletal pain and fibromyalgia. Also, to evaluate the differential characteristics of these two clinical groups of symptoms. Hypothesis: Patient‐centred consultation compared to the conventional treatment would decrease pain by one point on a 10‐point visual analogue scale Content of intervention: Trainers and doctors identified the presentation of the most common problems in primary care, the importance of psychosocial aspects of health and the general objectives of a consultation. Participating doctors practiced communication skills for establishing an effective relationship, obtaining biopsychosocial information, giving information, negotiating, and closing the interview. Role‐play, video examples, and interviews with simulated patients were used. Providers were taught data gathering, relationship building, informing/motivating/shared decision‐making, and behaviours and skills could be replicated Conceptual focus:
(Main features listed in Table 2 of the article) Duration and timing: 18 hours of training. Time spread is unclear Number of providers receiving intervention: 10/20 (start) 10/20 (end) Number of patient receiving intervention: 63/47/(start) 48/33/(end) Fidelity/integrity of intervention: 3 measures explored. (1) Consultation with standardized patient one week after training. (2) Process analysis of audiotapes of consultations. (3) Telephonic questionnaire to patients about experience of their consultation |
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| Outcomes |
Primary Outcomes: Intensity of Pain (Alamo 2002) & Brief Survey of patient questions (Moral 2001) Consultation process measures: Used GATHERES‐CP scoring system in videotaped consultation s to assess patient‐centeredness; provider able to discuss patient (patient report), observed to clearly discuss cause of pain, listen to and consider options and suggestions. Satisfaction: Patient experience of the consultation. Measured by survey at 2‐3 months. Health behaviours: NA Health status: Pain, depression & anxiety (Pain Scale of Nottingham Health Profile, Goldberg Scale of Anxiety, Depression) |
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| Notes | None | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Doctors were randomly assigned to two groups of 10 doctors" No data was given on sequence generation |
| Allocation concealment (selection bias) | Unclear risk | Randomized by clinic but not stated whether assignment was concealed |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Video tape coder was blinded to provider status. Telephone interviewer was blinded to patient status |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Of 29 dropouts, 15 were from experimental and 14 from control, but authors indicated intention to treat analysis was done |
| Selective reporting (reporting bias) | High risk | Sample size calculation was based on hypothesis that intervention compared to control would improve pain by one point on 10 point visual analogue scale. There was no statistical difference in this outcome, but authors reported greater improvement after 1 year in terms of psychological distress and number of tender points |
| Other bias | High risk | There was inadequate protection against contamination and potential for unit of analysis error was not adequately addressed. Moreover, baseline data were not collected |