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Enhanced care by generalists for functional somatic symptoms and disorders in primary care

  1. Marianne Rosendal1,*,
  2. Annette H Blankenstein2,
  3. Richard Morriss3,
  4. Per Fink4,
  5. Michael Sharpe5,
  6. Christopher Burton6

Editorial Group: Cochrane Depression, Anxiety and Neurosis Group

Published Online: 18 OCT 2013

Assessed as up-to-date: 13 AUG 2012

DOI: 10.1002/14651858.CD008142.pub2


How to Cite

Rosendal M, Blankenstein AH, Morriss R, Fink P, Sharpe M, Burton C. Enhanced care by generalists for functional somatic symptoms and disorders in primary care. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD008142. DOI: 10.1002/14651858.CD008142.pub2.

Author Information

  1. 1

    Aarhus University, Research Unit for General Practice, Institute of Public Health, Århus, Denmark

  2. 2

    VU University Medical Center, Department of General Practice and Elderly Care Medicine, Amsterdam, Netherlands

  3. 3

    University of Nottingham, Psychiatry, Nottingham, UK

  4. 4

    Århus University Hospital, Research Clinic for Functional Disorders and Psychosomatics, Århus, Denmark

  5. 5

    University of Oxford, Department of Psychiatry, Oxford, UK

  6. 6

    University of Aberdeen, Centre of Academic Primary Care, Aberdeen, UK

*Marianne Rosendal, Research Unit for General Practice, Institute of Public Health, Aarhus University, Bartholins Alle 2, Århus, DK-8000, Denmark. m.rosendal@alm.au.dk.

Publication History

  1. Publication Status: New
  2. Published Online: 18 OCT 2013

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Characteristics of included studies [ordered by study ID]
Blankenstein 2001

MethodsCluster RCT of modified reattribution versus usual care


ParticipantsGPs: 20 (intervention 10, control 10) (17 practices)

Patients: 162 (intervention 75, control 87), 20-45 years, 85-86% female

Frequent attenders with somatisation according to Escobar criteria of at least 6/4 medically unexplained symptoms for female/male patients


Interventions20 hours GP training - modified reattribution to include persistent illness worry and patient diaries. Treatment according to manual with registration forms for each session

Patient intervention: GPs applied intervention to pre-identified patients during normal consultation hours

Intervention semi-manualised as GPs had to follow and fill in a questionnaire about their intervention in each consultation with included patients


Outcomes1) GP consults; 24 (6, 12) months

2) Self-reported Health on VAS; 24 (6, 12) months

3) Self-reported sick leave; 24 (6, 12) months

4) Symptom load (SCL- SOM); 24 (6, 12) months


NotesOutcome data from thesis, no peer-reviewed publications.

Adherence in intervention group: applied in 51/75 patients, reattribution achieved in 33 /75.

Results reported as median + IQR, supplementary data on means provided.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskDrawing lots by independent statistician

Allocation concealment (selection bias)Low riskOpaque envelopes used for randomisation of practices

Recruitment biasLow riskPatients recruited before randomisation

Blinding (performance bias and detection bias)
All outcomes
High riskGPs not blinded. Blinding not stated for patients but the intervention included follow-up consultations. Unclear blinding of assessors, but they only managed questionnaire data

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAttrition < 10%, balanced between groups. Missing values in questionnaires below 15% except for sick leave (35%)

Selective reporting (reporting bias)Low riskPre-specified are reported but only in a PhD thesis, no publications on results

Other biasUnclear riskResults not adjusted for GP clustering, hence confidence intervals may be too narrow

Larisch 2004

MethodsCluster randomised RCT of trained GPs versus generic psychosocial primary care


ParticipantsGPs: 37 (1 per practice); (intervention: 20, control 17)

Patients: 127 (intervention 73, control 54), 18-65 years, 72% female

Inclusion: Screening using Escobar criteria of at least 6/4 medically unexplained symptoms for female/male patients + GHQ ≥ 2 + ≥ 5 consults in preceding year + symptom duration ≥ 3 months


InterventionsIntervention: Prior training in psychosocial primary care + 12 hours training in modified reattribution. Treatment according to manual

Control: Prior training in psychosocial primary care but no specific training during this trial

Patient intervention: 6x20 minute consultations, both groups


Outcomes1) Symptom load (SOMS); 12 (3, 6) months

2) Quality of life (SF-12 PCS); 12 (3, 6) months

3) Quality of life (SF-12 MCS); 12 (3, 6) months

4) Depression (HADS-D); 12 (3, 6) months

5) Anxiety (HADS-A); 12 (3, 6) months

6) GHQ; 12 (3, 6) months - not included in review analyses

7) Healthcare use; 12 (6) months


NotesAdherence: Intervention 4.8 sessions, Control 4.6 sessions per patient


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom number tables

Allocation concealment (selection bias)Low riskAllocation by statistician blinded to the GPs

Recruitment biasUnclear riskPatients recruited after GP randomisation and GPs involved in selection – but according to specified criteria

Blinding (performance bias and detection bias)
All outcomes
High riskGPs were not blinded. Patients were not informed about their GPs' grouping. Blinding of the assessors performing baseline interviews (information from author)

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskLow attrition at 3 months (10%), but high attrition at 12 months (40%); balanced between groups. Missing questionnaire data replaced by a random regression model

Selective reporting (reporting bias)Low riskAll pre-specified outcomes reported

Other biasLow riskBaseline imbalance with regard to age (younger in intervention group), anxiety scores and depression scores (higher in intervention group).

Adjustment for GP clustering (one participating GP per practice)

Morriss 2006

MethodsCluster randomised trial of reattribution versus usual care


ParticipantsGPs: 74 plus one nurse practitioner (N in intervention and controls not stated) (16 practices)

Patients: 141 (intervention: 66, control: 75), ≥ 18 years, 70% female

Independent GP assessment of MUS of at least 3 months duration


Interventions3x2 hours GP training in reattribution

Patient intervention: GPs applied intervention to patients during normal consultation hours


Outcomes1) Doctor-patient communications; index consultation - not included in review analyses

2) Patient satisfaction with communication; 3 months

3) Patient beliefs about symptoms; 3 months - not included in review analyses

4) Anxiety & Depression (HADS caseness); 3 months - not included in review analyses

5) Health Anxiety (Whiteley-14); 3 months

6) Quality of life (EQ5D); 3 months

7) Healthcare use; 3 months


NotesAdherence in intervention group: reattribution achieved in 31% of patients (compared to 2% in the CG)

Described as pilot trial, no long term follow-up


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated sequence

Allocation concealment (selection bias)Low riskAllocation of practices by trial statistician

Recruitment biasLow riskRecruited and assessed by research assistant and research GP before randomisation of practices

Blinding (performance bias and detection bias)
All outcomes
High riskGPs and nurses not blinded. Patients probably blinded. Assessors blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition <15% at 3 months (no longer term), comparable loss to follow-up between groups

Selective reporting (reporting bias)Unclear riskPilot trial only powered to measure primary outcome (communication). Anxiety and depression scores reported with no pre-consultation baseline measures

Other biasLow riskBaseline imbalance with regard to age (older in Intervention group)

Adjustment for GP clustering

Rief 2005

MethodsCluster randomised stepped wedge design with GPs allocated to training between phase 1/2 or phase 2/3


ParticipantsGPs: 26 (intervention 12, control 14)

Patients: 96 (intervention 46, control 50), 17-82 years, 69% female

Patient inclusion: identified by their GP, ≥ 2 MUS


Interventions8 hours training in managing MUS

Patient intervention: GPs applied intervention to patients during normal consultation hours


Outcomes1) Healthcare use, 6 months

2) Symptom load (SSI), 6 months (4 weeks) - not included in review analyses

3) Symptom load (SOMS), 6 months (4 weeks)

4) Depression (BDI), 6 months (4 weeks)

5) Illness worry (Whiteley-7), 6 months (4 weeks)

6) Anxiety (BAI), 6 months (4 weeks)


NotesDiffering cohorts of patients merged in analyses in the original publication

This review only includes cohort 2 (supplementary data provided)

No measures of adherence


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskThe sequence was generated with a dice (information from author)

Allocation concealment (selection bias)Low riskPractices randomised after full recruitment

Recruitment biasHigh riskRecruitment by GPs after randomisation

Blinding (performance bias and detection bias)
All outcomes
High riskGPs were not blinded. Patients were not informed about the GP grouping (information from author). Assessors may have been unblinded

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAttrition >30% at 6 months, balanced between groups

Selective reporting (reporting bias)Low riskUnpublished data on pre-specified outcomes included in this review

Other biasHigh riskAny baseline imbalance? cluster adjustments?

Training of control GPs 4 months after inclusion, follow-up at 6 months

Rosendal 2000

MethodsCluster randomised trial of GP training in the extended reattribution and management model versus usual care


ParticipantsGPs: 37 (intervention 20, control 17) (21 practices)

Patients 911 (intervention 506, control 405), 18-65 years, 65% female

Inclusion: Consulting GP for a new health problem + screen-positive on SCL-Som or Whiteley-7


Interventions25 hours GP training in the extended reattribution and management model

Patient intervention: GPs applied intervention to patients during normal consultation hours


Outcomes1) Quality of life (SF-36 PCS), 12 (3) months

2) Other SF-36 subscales, 12 (3) months

3) Symptoms (SCL-SOM), 12 (3) months

4) Mental distress SCL-8, 12 (3) months

5) Health Anxiety (Whitely-7), 12 (3) months

6) Patient satisfaction with care, 12 months


NotesNo measures of adherence

Large sample, mixed morbidity, only 164 of 911 patients recognised by GPs as somatisation


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation of blocks of practices after full recruitment

Allocation concealment (selection bias)Low riskAllocation performed by drawing practice numbers from opaque bag by neutral researcher

Recruitment biasUnclear riskRecruitment of patents after randomisation but using standardised questionnaires

Blinding (performance bias and detection bias)
All outcomes
High riskGPs not blinded. Patients not informed of GP allocation. Unclear blinding of assessors, but they only managed questionnaire data

Incomplete outcome data (attrition bias)
All outcomes
High riskHigh attrition rates (22-30% at 3/12, 26-35% at 12 months, highest in intervention group)

Selective reporting (reporting bias)Low riskAll pre-specified outcomes reported

Other biasLow riskBaseline imbalance with regard to education (more unskilled in Intervention Group) and SF-36 general health (lower score in Intervention Group)

Adjustment for GP clustering

Toft 2000

MethodsCluster randomised trial of the effect of training GPs versus usual care


ParticipantsGPs: 38 GPs (Intervention 19 GPs, Control 19 GPs) (30 practices)

Patients: 350 (Intervention 195, Control 155), 18-65 years, 73% female

Inclusion: any ICD10 somatoform disorder and subthreshold somatoform disorder (no duration limit)


Interventions25 hours training of GPs in the extended reattribution and management model

Patient intervention: GPs applied intervention to patients during normal consultation hours


Outcomes1) Quality of life (SF-36 PCS), 24 (3, 12) months

2) Other SF-36 subscales, 24 (3, 12) months

3) Symptom load (SCL-SOM); 24 (3, 12) months

4) Illness worry (Whiteley-7), 24 (3, 12) months

5) Patient satisfaction with care after index consultation (supplementary data provided)

6) Healthcare cost, 24 months


NotesNo measure of adherence during trial


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandomisation of blocks of practices after full recruitment

Allocation concealment (selection bias)Low riskAllocation performed by drawing practice numbers from opaque bag by neutral researcher

Recruitment biasUnclear riskRecruitment of patents after randomisation. Identification by independent research interview

Blinding (performance bias and detection bias)
All outcomes
High riskGPs unblinded. Patients not informed of GP allocation

Interview assessor blinded and other assessors only managed questionnaire data

Incomplete outcome data (attrition bias)
All outcomes
Low riskAttrition 20%, balanced between groups

Reported results based on respondents only, but imputations revealed comparable results

Selective reporting (reporting bias)Low riskMain outcome published including “negative” outcome

Other biasLow riskBaseline imbalance with regard to vocational training (more skilled in Intervention Group) and SF-36, physical functioning (lower score in Intervention Group)

Adjustment for GP clustering

Whitehead 2002

MethodsCluster randomised trial of primary care practices


ParticipantsUnknown number of practices and GPs

Patients: 65 (TG: 26, CG: 39), 15-66 years, 54-64% women


InterventionsOne hour training of GPs to deliver CBT-based treatment for Chronic Fatigue Syndrome and the possibility to attend two meetings, but few GPs did

Not stated for control group


Outcomes1) London Handicap Scale, 12 (6) months

2) Chalder Fatigue Scale, 12 (6) months

3) HADS (no information)


NotesEssential information missing, e.g. no specifications of standard deviations, confidence intervals or P values for outcomes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNot clearly stated

Allocation concealment (selection bias)Unclear riskNot clearly stated

Recruitment biasHigh riskRecruitment by GPs after randomisation and 50% of GPs did not recruit any patients

Blinding (performance bias and detection bias)
All outcomes
High riskGPs unblinded. Patients may have been unblinded. Unclear blinding of assessors, but they only managed questionnaire data

Incomplete outcome data (attrition bias)
All outcomes
High riskAttrition rates 28-31% at 6 months and 46-65% at 12 months; higher in the Intervention Group

Selective reporting (reporting bias)Unclear riskNo specifications of primary outcome, few analyses performed

Other biasUnclear riskMissing information on several issues (e.g. number of GP participants in each group, information provided to control GPs and data on patients not recruited or lost during follow-up)

Analytic approach not described

Baseline imbalance (patients in the Intervention Group were 5 years younger and had 6 months shorter symptom duration), stated as statistically insignificant

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Aiarzaguena 2007Two interventions compared, no usual care group for comparison

Alamo 2002Intervention does not include reattribution or reframing of symptoms

Allen 2006Intervention by specialist practitioners and patient recruitment not limited to primary care

Bakker 2007Patiens do not fulfil criteria for functional symptoms

Barsky 2004Intervention by specialist practitioners

Bernal 1995Intervention by specialist practitioner and results not stated separately from anxiety disorders

Escobar 2004Intervention by specialist practitioners

Huibers 2004Intervention by specialist practitioners

Jellema 2005Intervention does not include reattribution or reframing of symptoms

Kennedy 2001Intervention by specialist practitioners (nurse practitioners)

Klapow 2001Patiens do not fulfil criteria for functional symptoms

Leonhardt 2008Patiens do not fulfil criteria for functional symptoms

Lidbeck 1997Intervention by specialist practitioners (GPs, but not their own patients)

Lofvander 2002Intervention by specialist practitioners and patient recruitment not limited to primary care

Magallon 2008Intervention by specialist practitioners

Margalit 2008Intervention by specialist practitioners (GPs, but not their own patients)

Martin 2007Intervention by specialist practitioners

McLeod 1997Intervention by specialist practitioners

Pols 2008Intervention dependent on assistance to GPs provided by specialised service co-ordinators (collaborative care)

Ridsdale 2001Intervention by specialist practitioners

Schade 2011Intervention by specialist practitioners (family doctors, psychologists, social workers, dentists etc.)

Schaefert 2011Intervention by specialist practitioners

Schilte 2001Intervention by specialist practitioners

Smith 2006Intervention by specialist practitioners (nurse practitioners)

Smith 2009Intervention by specialist practitioners (primary care physicians, but not their own patients)

Sumathipala 2008Two interventions compared, no usual care group for comparison

van Bokhoven 2009Intervention on diagnostics only, not enhanced care

van der Horst 1997Intervention does not include reattribution or reframing of symptoms

 
Comparison 1. Health related quality of life

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Change in physical health 6-24 months4Std. Mean Difference (IV, Random, 95% CI)Totals not selected

 2 Change in physical health 1-3 months4Std. Mean Difference (IV, Random, 95% CI)Totals not selected

 3 Change in mental health 6-24 months3795Std. Mean Difference (IV, Random, 95% CI)-0.04 [-0.18, 0.10]

 4 Change in mental health 1-3 months3904Std. Mean Difference (IV, Random, 95% CI)-0.00 [-0.13, 0.13]

 
Comparison 2. Physical symptoms

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Change in physical symptoms 6-24 months5Std. Mean Difference (IV, Random, 95% CI)Totals not selected

 2 Change in physical symptoms 1-3 months4Std. Mean Difference (IV, Random, 95% CI)Totals not selected

 
Comparison 3. Illness worry

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Change in illness worry 6-24 months3928Std. Mean Difference (IV, Random, 95% CI)0.09 [-0.04, 0.22]

 2 Change in illness worry 1-3 months41141Std. Mean Difference (IV, Random, 95% CI)0.07 [-0.06, 0.19]

 
Comparison 4. Depression and anxiety

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Change in depression 6-24 months41007Std. Mean Difference (IV, Random, 95% CI)0.07 [-0.05, 0.20]

 2 Change in depression 1-3 months51259Std. Mean Difference (IV, Random, 95% CI)-0.00 [-0.16, 0.15]

 3 Change in anxiety 6-24 months2153Std. Mean Difference (IV, Random, 95% CI)-0.07 [-0.38, 0.25]

 4 Change in anxiety 1-3 months3Std. Mean Difference (IV, Random, 95% CI)Subtotals only

 
Comparison 5. Discontinuation of follow-up

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Discontinuation 6-24 months51646Risk Ratio (M-H, Random, 95% CI)1.25 [1.08, 1.46]

 2 Discontinuation 1-3 months51625Risk Ratio (M-H, Random, 95% CI)1.28 [1.06, 1.54]

 
Table 1. Frequently used instruments for the assessment and sampling of functional somatic symptoms and disorders

Type of instrumentNamereferences

QuestionnaireAbridged criteria/Escobar criteria/SOMSEscobar 1989

 PHQ-15Kroenke 2002

 SCL-12 (SCL-90 somatization scale)Derogatis 1977

 Whiteley (7 or 14)Fink 1999

GHQGoldberg 1988

InterviewSCANWorld Health Organisation 1998 

 DISEaton 2000; Robins 1989

 CIDIAndrews 1995; World Health Organisation 1990

Health care useFrequent attendanceBlankenstein 2001; Katon 1992;Portegijs 1996;Schilte 2001

 The table may be supplemented by specific instruments for functional somatic syndromes.
SOMS: Screening for somatoform Symptoms; PHQ: Patient Health Questionnaire; SCL: Symptom Check List; GHQ: General Health Questionnaire; SCAN: Schedules for Clinical Assessment in Neuropsychiatry; DIS: Diagnostic Interview Schedule; CIDI: Composite International Diagnostic Interview.
 
Table 2. Data extraction form

RubricReviewer1Reviewer 2Conclusion

Study ID, name of study

Report ID

Author name and year   

Title of paper   

Contact details   

Personal notes (e.g. name of disorder used)   

Assessment of eligibilityIntervention provided by generalist

Intervention deals with non-biomedical aspects

Patients have MUS or functional syndrome(s)

RCT

Personal notesReason for exclusion  

Study characteristics   

MethodsStudy design including level of randomisation and measures of clustering   

Study duration

Sequence generation

Allocation concealment

Blinding (clinician, patient, researcher)

Incomplete data (short term, longer term)

Reporting (prespecified, incidental)

Recruitment bias

 The risk of contamination (control patients receiving intervention unintentional or vice versa)   

Other concerns about bias

 Participating GPsNumber of GPs/practices

Setting of the study (the primary care organisation and country)

Doctor characteristics and sampling (previous training, years in practice, GP age)   

 Participating patientsNumber of patients in each group

Diagnostic criteria and instrument used

Patient characteristics (inclusion, exclusion, ethnicity, diagnosis, symptom duration, psychiatric co-morbidity) and sampling (population screening, waiting room screening, GP assessment, diagnostic instruments used)   

Date of study

InterventionNumber of groups

Intervention* in active group and adherence   

 Intervention in control group and adherence   

 OutcomesPrimary and secondary outcomes: time from randomisation, measure, tool used, definition, unit of measurement, definition of positive outcome   

 Length of maximum follow-up   

AnalysisType (e.g. intention to treat)

Missing data (attempts to minimise, handling of)

Covariate choice

Power, anticipated effect and sample size adjustment

ResultsNumber of participants in each group   

Primary and secondary outcomes: sample size, missings, summary data for each group, estimate of effect, subgroup analyses

OtherFunding, key conclusions by authors

Comments

 * Interventions
  • Training (duration, content, skills training, supervision)
  • Treatment model: reattribution and how close it is to the original, psychosocial interventions other than reattribution). To which degree does the model for patients stipulate that physical symptoms are secondary to psychosocial distress.
  • Clinicians (GP, nurse, other)
  • Organisation (flagging of patients, consultation duration, number of consultations, no changes)

 
Table 3. Summary of interventions and populations in studies for quantitative analyses

StudyTraining intensityInterventionDelivery intensityManual and adherenceProportion population eligible

Blankenstein20 hour programme, included discussion of audio taped consultations and booster sessionsReattribution +
(a) negotiate a definitive test
(b) GP delay own interpretation

(c) symptom diaries
“during usual care” at least two appointments.Intervention registration forms filled in by GP during consultations with included patients.

Adherence: intervention was applied to 51 of 75 patients (68%). Reattribution was achieved in 33 of 75 patients (31%)
Registered 33,000 (11,000 age 20-45 ˜34% of population)

Screened 900 (Frequent attenders: top 8%) 

Eligible 243 ( > = 5 on DSM3 symptoms checklist)

(age 20-45 only)

0.74%

Larisch12 hour programme,

Teaching, pre-recorded video, role playing
Training based on reattribution modified for German PHC setting:

(a) emphasised examination

(b) symptom diaries
6x20 minute appointments every 2 weeksManual with therapy protocols for each of the 6 patient sessions.

Adherence not reported.
Registered 34,000 (42 GPs x 800 patients / GP)

Screened 847 (waiting room + GP opportunistic)

Eligible 222  (4M/6F on SOMS + GHQ>2)

0.65%

Morriss3x2hours

Teaching, pre-recorded video, role playing
Reattribution:

(a) feeling understood
(b) broadening the agenda to bring psychosocial and physical together

(c) making the link
(d) planning future management
Single clinic appointmentNo manual but specific consultation model (reattribution) which was audio taped for evaluation.

Adherence: Intervention GPs communicated reattribution in most of the consultation in 20 of 65 patients (31%)
Registered 102,000 (16 x 6400)

Screened 4484 in 430 clinics

Eligible 141 (current MUS >3 months)

0.14%

RiefOne day

Teaching, pre-recorded video, role playing (“if necessary”)
“Synthesis of” reattribution + additional information.
(a) communication

(b) stopping medical investigations

(c) handling organic health beliefs and need for reassurance

(d) options for further treatment
Not specified. “encouraged to make regular appointments”No manual or measurement of adherence.Registered 20,800 (26 GPs x 800 patients / GP)

Eligible 289 (96 in cohort 2) selected by GPs as 2 or more MUS

(non-randomised design, no record of individual consent / opt-in or out??)

1.4%

Rosendal2 day residential + 3x2hour sessions

Analysis of own video consultations

+ outreach visit after 6/12
Extended reattribution and management

(a) understanding – including brief focused exam
(b) stating GPs expertise
(c) negotiating explanations
(d) planning further treatment

(e) principles for management of chronic conditions
Not specifiedNo manual or measurement of adherence.Population 66,500 (19% GPs serving 350,000 residents)

2880 screened

Eligible 911 (either 4+ symptoms on SCL-SOM or 2+ on Whitely-7)

1.4%

Toft2 day residential + 3x2hour sessions

Analysis of own video consultations

+ outreach visit after 6/12
Extended reattribution and management

(a) understanding – including brief focused exam
(b) stating GPs expertise
(c) negotiating explanations
(d) planning further treatment

(e) principles for management of chronic conditions
Not specifiedNo manual or measurement of adherence.Population 54,000 (9%GPs serving 600,000 residents)

1785 screened (attenders 18-65 consulting new health problem)

Eligible 350 (Somatoform Disorder according to SCAN)

0.65%

 
Table 4. Criteria for the assessment of methodological quality of included studies

ItemDescriptionScoring: yes, unclear or no

Selection biasRandom sequence generationWas the allocation sequence adequately generated?A method for random allocation at the level of the doctor or patient must have been applied and stated.

Allocation concealmentWas allocation adequately concealed?Allocation should have been performed by an independent person without any influence on the allocation sequence or the decision about eligibility for inclusion.

Recruitment biasWere patients recruited before or after randomisation of doctors/practices?If patients were recruited after randomisation at the level of the doctor/practice the recruitment could be affected by the practice awareness of allocation group to some degree (instruments for inclusion applied) or to a high degree (inclusion under direct influence of the doctor)

Performance and detection biasBlindingWas knowledge of the allocated intervention prevented during the study at the level of the doctor, patient and assessor?We defined:

Low risk = attempt to conceal from doctor AND patients AND assessors blinded.

Unclear risk = Unclear blinding of patient, doctor and/or assessor but none unblinded.

High risk = either no attempt to conceal from doctor OR patients OR assessor not blinded

Attrition biasIncomplete outcome dataWere loss to follow-up acceptable and was attrition addressed?Information about included patients lost to follow-up. Attrition above 30% was rated as high risk.

Reporting biasSelective reportingReporting of selective outcome?Were primary outcomes stated and reported? Were other findings reported as such?

Other biasWas the study free of other problems that could put it at a high risk of bias?Specific attention paid to whether statistics were adjusted for the effect of clustering of patients with GPs or practices.