Scolaris Content Display Scolaris Content Display

Sistemas de recordatorio para mejorar la adherencia de los pacientes a las citas médicas para el diagnóstico y el tratamiento de la tuberculosis

Contraer todo Desplegar todo

Referencias

Referencias de los estudios incluidos en esta revisión

Cheng 1997 {published data only}

Cheng TL, Ottolini MC, Baumhaft K, Brasseux C, Wolf MD, Scheidt PC. Strategies to increase adherence with tuberculosis test reading in a high‐risk population. Pediatrics 1997;100(2 Pt 1):210‐3.

Krishnaswami 1981 {published data only}

Krishnaswami KV, Somasundaram PR, Tripathy SP, Vaidyanathan B, Radhakrishna S, Fox WA. Randomised study of two policies for managing default in out‐patients collecting supplies of drugs for pulmonary tuberculosis in a large city in South India. Tubercle 1981;62(2):103‐12.

Kunawararak 2011 {published data only}

Kunawararak P, Pongpanich S, Chantawong S, Pokaew P, Traisathit P, Srithanaviboonchai K, et al. Tuberculosis treatment with mobile‐phone medication reminders in Northern Thailand. Southeast Asian Journal of Tropical Medicine and Public Health 2011;42(6):1444‐51.

Mohan 2003 {published data only}

Mohan A, Nassir H, Niazi A. Does routine home visiting improve the return rate and outcome of DOTS patients who delay treatment?. Eastern Mediterranean Health Journal 2003;9(4):702‐8.

Paramasivan 1993 {published data only}

Paramasivan R, Parthasarathy RT, Rajasekaran S. Short course chemotherapy: A controlled study of indirect defaulter retrieval method. Indian Journal of Tuberculosis 1993;40(4):185‐90.

Roberts 1983a {published data only}

Roberts MC. Wurtele SK, Leeper JD. Experiments to increase return in a medical screening drive: two futile attempts to apply theory to practice. Social Science & Medicine 1983;17(11):741‐6.

Roberts 1983b {published data only}

Roberts MC, Wurtele SK, Leeper JD. Experiments to increase return in a medical screening drive: two futile attempts to apply theory to practice. Social Science & Medicine 1983;17(11):741‐6.

Salleras Sanmarti 1993 {published data only}

Salleras Sanmarti L, Alcaide Megias J, Altet Gomez MN, Canela Soler J, Navas Alcala E, Suñe Puigbo MR, et al. Evaluation of the efficacy of health education on the compliance with antituberculosis chemoprophylaxis in school children. A randomized clinical trial. Tubercle and Lung Disease 1993;74(1):28‐31.

Tanke 1994 {published data only}

Tanke ED, Leirer VO. Automated telephone reminders in tuberculosis care. Medical Care 1994;32(4):380‐9.

Referencias de los estudios excluidos de esta revisión

Ailinger 2010 {published data only}

Ailinger RL, Martyn D, Lasus H, Lima Garcia N. The effect of a cultural intervention on adherence to latent tuberculosis infection therapy in Latino immigrants. Public Health Nursing 2010;27(2):115‐20.

Akhtar 2011 {published data only}

Akhtar S, Rozi S, White F, Hasan R. Cohort analysis of directly observed treatment outcomes for tuberculosis patients in urban Pakistan. International Journal of Tuberculosis and Lung Disease 2011;15(1):90‐6.

Alcaide Megías 1990 {published data only}

Alcaide Megías J, Altet Gómez MN, Canela Soler J, Serra Majen L, Garrido Morales P, Navas Alcalá E, et al. Influence of health education on compliance with antituberculous chemoprophylaxis in children: a community trial [Influencia de la educación sanitaria en el cumplimiento de la quimioprofilaxis antituberculosa en niños: ensayo comunitario]. Revista Clínica Española 1990;187(2):89‐93.

Al‐Hajjaj 2000 {published data only}

Al‐Hajjaj MS, Al‐Khatim IM. High rate of non‐compliance with anti‐tuberculosis treatment despite a retrieval system: a call for implementation of directly observed therapy in Saudi Arabia. International Journal of Tuberculosis and Lung Disease 2000;4(4):345‐9.

Alvarez Gordillo 2003 {published data only}

Alvarez Gordillo GdelC, Alvarez Gordillo JF, Dorantes Jiménez JE. Educational strategy for improving patient compliance with the tuberculosis treatment regimen in Chiapas, Mexico [Estrategia educativa para incrementar el cumplimiento del regimen antituberculoso en Chiapas, Mexico]. Revista Panamericana de Salud Pública 2003;14(6):402‐8.

Atkins 2011 {published data only}

Atkins S, Lewin S, Jordaan E, Thorson A. Lay health worker‐supported tuberculosis treatment adherence in South Africa: an interrupted time‐series study. International Journal of Tuberculosis and Lung Disease 2011;15(1):84‐9.

Barclay 2009 {published data only}

Barclay E. Text messages could hasten tuberculosis drug compliance. Lancet 2009;373(9657):15‐6.

Bordley 2001 {published data only}

Bordley WC, Margolis PA, Stuart J, Lannon C, Keyes L. Improving preventive service delivery through office systems. Pediatrics 2001;108(3):e41.

Bronner 2012 {published data only}

Bronner LE, Podewils LJ, Peters A, Somnath P, Nshuti L, van der Walt M, et al. Impact of community tracer teams on treatment outcomes among tuberculosis patients in South Africa. BMC Public Health 2012;12:621.

Grant 2010 {published data only}

Grant AD, Coetzee L, Fielding KL, Lewis JJ, Ntshele S, Luttig MM, et al. 'Team up against TB': promoting involvement in Thibela TB, a trial of community‐wide tuberculosis preventive therapy. AIDS 2010;24(Suppl 5):S37‐44.

Hovell 2003 {published data only}

Hovell MF, Sipan CL, Blumberg EJ, Hofstetter CR, Slymen D, Friedman L, et al. Increasing Latino adolescents' adherence to treatment for latent tuberculosis infection: a controlled trial. American Journal of Public Health 2003;93(11):1871‐7.

Hsieh 2007 {published data only}

Hsieh CJ, Lin LC, Kuo BI, Chiang CH, Su WJ, Shih JF. Exploring the efficacy of a case management model using DOTS in the adherence of patients with pulmonary tuberculosis. Journal of Clinical Nursing 2007;17(7):869‐75.

Hunchangsith 2010 {published data only}

Hunchangsith P, Barendregt JJ, Vos T, Bertram M. Cost‐effectiveness of different strategies for tuberculosis control programs in Thailand [abstract]. ISPOR 4th Asia‐Pacific Conference, Phuket, Thailand, 5 ‐ 7 September 2010. Value in Health 2010;13(7):A504‐5.

Hunchangsith 2012 {published data only}

Hunchangsith P, Barendregt JJ, Vos T, Bertram M. Cost‐effectiveness of various tuberculosis control strategies in Thailand. Value in Health 2012;15(1 Suppl):S50‐5.

Iribarren 2013 {published data only}

Iribarren S, Beck S, Pearce PF, Chirico C, Etchevarria M, Cardinale D, et al. Text TB: a mixed method pilot study evaluating acceptance, feasibility, and exploring initial efficacy of a text messaging intervention to support TB treatment adherence. Tuberculosis Research and Treatment 2013;349394:1‐12.

Jin 1993 {published data only}

Jin BW, Kim SC, Mori T, Shimao T. The impact of intensified supervisory activities on tuberculosis treatment. Tubercle and Lung Disease 1993;74(4):267‐72.

Krishna 2002 {published data only}

Krishna S, Balas EA, Boren SA, Maglaveras N. Patient acceptance of educational voice messages: a review of controlled clinical studies. Methods of Information in Medicine 2002;41(5):360‐9.

Lin 2006 {published data only}

Lin RL, Lin FJ, Wu CL, Peng MJ, Chen PJ, Kuo HT. Effect of a hospital‐based case management approach on treatment outcome of patients with tuberculosis. Journal of the Formosan Medical Association 2006;105(8):636‐44.

Morisky 1990 {published data only}

Morisky DE, Malotte CK, Choi P, Davidson P, Rigler S, Sugland B, et al. A patient education program to improve adherence rates with antituberculosis drug regimens. Health Education Quarterly 1990;17(3):253‐67.

Morisky 2001 {published data only}

Morisky DE, Malotte CK, Ebin V, Davidson P, Cabrera D, Trout PT, et al. Behavioral interventions for the control of tuberculosis among adolescents. Public Health Reports 2001;116(6):568‐74.

Nyamathi 2007 {published data only}

Nyamathi A, Stein JA, Schumann A, Tyler D. Latent variable assessment of outcomes in a nurse‐managed intervention to increase latent tuberculosis treatment completion in homeless adults. Health Psychology 2007;26(1):68‐76.

Sanneh 2010 {published data only}

Sanneh AFNS, Pollock JI. Comparison of Pulmonary TB DOTS clinic medication before and after the introduction of daily DOTS treatment and attitudes of treatment defaulters in the Western Division of the Gambia. African Health Sciences 2010;10(2):165‐71.

Tanke 1997 {published data only}

Tanke ED, Martinez CM, Leirer VO. Use of automated reminders for tuberculin skin test return. American Journal of Preventive Medicine 1997;13(3):189‐92.

Thiam 2007 {published data only}

Thiam S, LeFevre AM, Hane F, Ndiaye A, Ba F, Fielding KL, et al. Effectiveness of a strategy to improve adherence to tuberculosis treatment in a resource‐poor setting: a cluster randomized controlled trial. JAMA 2007;297(4):380‐6.

Tokzek 2012 {published data only}

Toczek A, Cox H, du Cros P, Cooke G, Ford N. Strategies for reducing treatment default in drug‐resistant tuberculosis: systematic review and meta‐analysis. International Journal of Tuberculosis and Lung Disease 2012;17(3):299‐307.

Yusuf 2011 {published data only}

Yusuf K. Incentives to improve tuberculosis treatment adherence. 6th EDCTP Forum: Strengthening Research Partnerships for Better Health and Sustainable Development; 2011 Oct 9‐12; Addis Ababa. EDCPT, 2011:205.

Referencias de los estudios en curso

CTRI/2011/07/001889 {published and unpublished data}

CTRI/2011/07/001889. The development and evaluation of m‐Health service in the control of Tuberculosis (TB) in India ‐ TIMTAM trial. http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2883 (accessed 03 February 2014).

ISRCTN46846388 {unpublished data only}

ISRCTN46846388. Cluster randomized trial of using mobile text messaging and a medication monitor in tuberculosis (TB) case management. http://isrctn.org/ISRCTN46846388 (accessed 20 January 2014).

NCT01471977 {published and unpublished data}

NCT01471977. Interventions to promote adherence to tuberculosis treatment among patients attending basic medical unit of Taluka Gambat, Pakistan. http://clinicaltrials.gov/ct2/show/NCT01471977 (accessed 17 October 2012).

NCT01549457 {published and unpublished data}

NCT01549457. A randomized controlled trial to examine the effectiveness of use of mobile phones and text messaging to improve adherence to treatment of latent TB. http://clinicaltrials.gov/show/NCT01549457 (accessed 10 February 2014).

NCT01690754 {published and unpublished data}

NCT01690754. Evaluating the effectiveness of interactive SMS reminders on TB drug compliance and treatment. http://clinicaltrials.gov/ct2/show/NCT01690754 (accessed 17 October 2012).

NCT02082340 {published and unpublished data}

NCT02082340. Innovative approach in tuberculosis care in Armenia. http://clinicaltrials.gov/show/NCT02082340 (accessed 31 March 2014).

PACTR201307000583416 {published and unpublished data}

PACTR201307000583416. Evaluation of therapeutic adherence support by SMS on the cure rate of Tuberculosis: a protocol of a randomized control study. http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201307000583416 (accessed 03 February 2014).

Bediang 2014

Bediang G, Stoll B, Elia N, Abena JL, Nolna D, Chastonay P, et al. SMS reminders to improve the tuberculosis cure rate in developing countries (TB‐SMS Cameroon): a protocol of a randomised control study. Trials 2014;15:35.

Goble 1993

Goble M, Iseman MD, Madsen LA, Waite D, Ackerson L, Horsburgh CR. Treatment of 171 patients with pulmonary tuberculosis resistant to isoniazid and rifampin. New England Journal of Medicine 1993;328(8):527‐32.

Green 2003

Green D. ICT‐enabled development case studies series: The compliance service uses SMS technology for TB treatment. http://www.comminit.com/global/content/compliance‐service‐uses‐sms‐technology‐tb‐treatment (accessed 21 October 2014).

Guyatt 2008

Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck‐Ytter Y, Schünemann HJ, GRADE Working Group. What is "quality of evidence" and why is it important to clinicians?. BMJ 2008;336(7651):995‐8.

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Jagota 1996

Jagota P, Sreenivas TR, Parimala N. Improving treatment compliance by observing difference in treatment irregularity. Indian Journal of Tuberculosis 1996;43:75‐80.

Johansson 1999

Johansson E, Long NH, Diwan VK, Winkvist A. Attitudes to compliance with tuberculosis treatment among women and men in Vietnam. International Journal of Tuberculosis and Lung Disease 1999;3(10):862‐8.

Lefebvre 2011

Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Lutge 2012

Lutge EE, Wiysonge CS, Knight SE, Volmink J. Material incentives and enablers in the management of tuberculosis. Cochrane Database of Systematic Reviews 2012, Issue 1. [DOI: 10.1002/14651858.CD007952.pub2]

M'Imunya 2012

M'Imunya JM, Kredo T, Volmink J. Patient education and counselling for promoting adherence to treatment for tuberculosis. Cochrane Database of Systematic Reviews 2012, Issue 5. [DOI: 10.1002/14651858.CD006591.pub2]

Mitchison 1998

Mitchison DA. How drug resistance emerges as a result of poor compliance during short course chemotherapy for tuberculosis. International Journal of Tuberculosis and Lung Disease 1998;2(1):10‐5.

National Department of Health South Africa 2014

National Tuberculosis Management Guidelines 2014. National Department of Health South Africa http://www.health‐e.org.za/2014/06/10/guidelines‐national‐tuberculosis‐management‐guidelines/ (Accessed 21 October 2014).

Nglazi 2013

Nglazi MD, Bekker LG, Wood R, Hussey GD, Wiysonge CS. Mobile phone text messaging for promoting adherence to anti‐tuberculosis treatment: a systematic review. BMC Infectious Diseases 2013;13:566.

O'Boyle 2002

O'Boyle SJ, Power JJ, Ibrahim MY, Watson JP. Factors affecting patient compliance with anti‐tuberculosis chemotherapy using the directly observed treatment, short‐course strategy (DOTS). International Journal of Tuberculosis and Lung Disease 2002;6(4):307‐12.

Ormerod 1991

Ormerod LP, Prescott RJ. Inter‐relations between relapses, drug regimens and compliance with treatment in tuberculosis. Respiratory Medicine 1991;85(3):239‐42.

Review Manager 5 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.

Steingart 2014

Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N. Xpert® MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database of Systematic Reviews 2014, Issue 1. [DOI: 10.1002/14651858.CD009593.pub3]

Thilakavathi 1993

Thilakavathi S, Fredrick JS, Fredrick KG, Parthasarathy R, Santha T, Somasundaram PR, et al. High coverage for long term follow‐up of patients with spinal tuberculosis. Indian Journal of Tuberculosis 1993;40(2):91‐4.

Vann 2005

Jacobson Vann JC, Szilagyi P. Patient reminder and recall systems to improve immunization rates. Cochrane Database of Systematic Reviews 2005, Issue 3. [DOI: 10.1002/14651858.CD003941.pub2]

Visarutrat 2009

Visarutrat S. Mobile phone for increase success rate of TB treatment outcome in TB patients. Chiang Mai PCMO preliminary report. Chiang Mai: Chiang Mai Provincial Health Office2009.

Volmink 2007

Volmink J, Garner P. Directly observed therapy for treating tuberculosis. Cochrane Database of Systematic Reviews 2007, Issue 4. [DOI: 10.1002/14651858.CD003343.pub3]

Weis 1994

Weis SE, Slocum PC, Blais FX, King B, Nunn M, Matney GB, et al. The effect of directly observed therapy on the rates of drug resistance and relapse in tuberculosis. New England Journal of Medicine 1994;330(17):1179‐84.

WHO 2003a

WHO Global Tuberculosis Programme. Treatment of tuberculosis: guidelines for national programmes [WHO/CDS/TB/2003.313]. 3rd Edition. Geneva: World Health Organization, 2003.

WHO 2003b

World Health Organization. Adherence to long term therapies: evidence for action. Geneva: World Health Organization, 2003.

WHO 2006

The Stop TB Strategy. Geneva, World Health Organization, 2006 (WHO/HTM/TB/2006.368).

WHO 2011

World Health Organization. Policy statement: automated real‐time nucleic acid amplification technology for rapid and simultaneous detection of tuberculosis and rifampicin resistance: Xpert MTB/RIF system. http://apps.who.int/iris/bitstream/10665/44586/1/9789241501545_eng.pdf?ua=1 (accessed 21 October 2014).

WHO 2013

World Health Organization. Global tuberculosis report. WHO Report 2013. WHO/HTM/TB/2013.11. Geneva: World Health Organization, 2013.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Cheng 1997

Methods

Trial design: Quasi‐RCT

Participants

Number of participants: 627 randomized

Inclusion criteria: consecutive children ages 1 to 12 years due for a TB test in an urban children's hospital outpatient department; 1 child per family enrolled

Exclusion criteria: not stated

Interventions

All patients received a written information sheet with the times to return; skin tests were circled in permanent marker and date of return stamped on mother's and child's hands

All families received education regarding the importance of skin testing for TB and the need for follow‐up to read the results. Instructions were given to return to the clinic in 48 to 72 hours

Intervention of interest:

  • Reminder pre‐appointment phone call 1 day before the appointment.

Control:

  • Routine verbal and written instructions.

Other interventions not included in this review:

  • Positive reinforcement group (transportation tokens and toy on return).

  • Negative reinforcement group (asked to leave school forms until they returned for test reading and were told that the test would be repeated if not read on time).

  • Parents trained to read the Mantoux TB test for induration or no induration, and a nurse home visit was scheduled to verify results.

Outcomes

Outcomes included in this review:

  • Adherence to return visit for Mantoux test reading.

Outcomes not included in this review :

  • Reasons for poor adherence.

Notes

Location: USA

Trial dates: not specified

Baseline data: comparable

Funding: Ambulatory Pediatrics Association

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Randomized by day of the week.

Allocation concealment (selection bias)

High risk

Sequential allocation.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

627/627 (100%), no missing data.

Selective reporting (reporting bias)

Low risk

All relevant outcomes in the methods section are reported in the results section.

Other bias

Low risk

None identified.

Krishnaswami 1981

Methods

Trial design: RCT

Participants

Number of participants: 170 randomized; 150 analysed

Inclusion criteria: patients with symptoms reporting at the Institute of Tuberculosis and Chest Diseases in Madras; with radiographic evidence of TB but negative smears; aged ≥ 12 years; prescribed national TB programme recommended regimen; living within a radius of about 5 km from the clinic; bona fide residents of Madras city and regarded as stable (expected to remain in the city for at least 1 year)

Exclusion criteria: not stated

Interventions

Intervention of interest:

  • Home visits 4 days after a missed appointment. If necessary, further visits were made on the 11th day, and at 1 and 2 months. At one of the latter 2 visits, a doctor accompanied the health visitor if the latter had met the patient at an early visit but had failed to persuade the patient to attend.

  • Reminder letter 4 days after a missed appointment ‐ in Tamil (the local language). If the patient still failed to attend, a health visitor went to the home on the 11th day to see the patient personally and persuade him or her to attend.

Outcomes

Outcomes included in this review:

  • Treatment completion.

  • Retrieval of the defaulters with the first action for the first episode of default.

Outcomes not included in this review:

  • Retrieval of the defaulters with the first action for all episodes of default.

  • Mean number of drug collections for one year.

  • Number of episodes of default.

Notes

Location: South India

Trial dates: not specified

Funding: Indian Council of Medical Research

Baseline data: comparable

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Only described as "randomised".

Allocation concealment (selection bias)

Unclear risk

Only described as "randomised".

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

150/170 (89%); 20 participants excluded from main analysis because of death (8), lost to follow‐up (6), chemotherapy change (3), or transfer to more accessible clinics (3), but missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups.

Selective reporting (reporting bias)

Low risk

All relevant outcomes in the methods section are reported in the results section.

Other bias

Low risk

None identified.

Kunawararak 2011

Methods

Trial design: RCT

Participants

Number of participants: 98 randomized

Inclusion criteria: patients aged > 15 years diagnosed with MTB who had never been treated with second line TB drugs, patients in whom DST and HIV testing were performed and whose liver function tests were lower than 2 times the upper limits of normal.

Exclusion criteria: pregnant patients, MDR‐TB patients resistant to 3 or more of 6 classes of second‐line drugs, patients with history of epilepsy or alcoholism, patients who could not answer questions by the researcher and patients who could not complete the treatment.

Interventions

All patients had DOTS

Intervention of interest:

  • Mobile phone call reminder to attend clinic appointments and take their medication.

Control:

  • No reminder.

Outcomes

Outcomes included in this review:

  • Treatment completion.

Outcomes not included in this review:

  • Cure.

  • Failure.

  • Success.

  • Sputum conversion rate at 1 month.

Notes

Location: Northern Thailand

Trial dates: April 2008 to December 2009

Baseline data: comparable

Funding: Graduate School of Chulalongkorn University, and the Department of Disease Control, MInistry of Public Health, Thailand

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Only described as "randomised".

Allocation concealment (selection bias)

Unclear risk

Only described as "randomised".

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data, 98/98 (100%).

Selective reporting (reporting bias)

Low risk

All relevant outcomes in the methods section are reported in the results section.

Other bias

Low risk

None identified.

Mohan 2003

Methods

Trial design: RCT

Participants

Number of participants: 480 randomized

Inclusion criteria: new smear‐positive PTB; never been treated previously; delayed coming to collect drugs at the health centre for at least 3 days after scheduled appointment; identified from official patient record cards

Exclusion criteria: re‐treatment patients

Interventions

Intervention of interest:

  • Home visit by a local female volunteer from a local nongovernmental organization who was trained to motivate patient to attend health centre daily and to give health education (co‐intervention) for the patient and his or her family.

Control:

  • No home visit.

Outcomes

Outcomes included in this review:

  • Treatment completion.

Outcomes not included in this review:

  • Treatment interrupted for ≥ 2 consecutive months.

  • Treatment failure: patient who is sputum positive at 5 months or later during treatment.

  • Death.

  • Sputum smear positive follow‐up.

Notes

Location: Iraq

Trial dates: May 2001 to May 2002

Baseline data: not reported

Funding: the EMRO/DCD/TDR Small Grants Scheme for Operational Research in Tropical and Communicable Diseases

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

By random‐numbers table (confirmed by the trial authors).

Allocation concealment (selection bias)

Low risk

Using sequentially numbered and sealed opaque envelopes (confirmed by the trial authors).

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

The evaluation was blind as the information about outcome was collected by a field worker who did not know which group the patients were assigned to.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data, 480/480 (100%).

Selective reporting (reporting bias)

Low risk

All relevant outcomes in the methods section are reported in the results section.

Other bias

Low risk

None identified.

Paramasivan 1993

Methods

Trial design: RCT

Participants

Number of participants: 200 randomized

Inclusion criteria: newly diagnosed adult PTB patients; sputum positive for acid‐fast bacilli (AFB); no treatment or < 15 days previous treatment; not in moribund condition or suffering from disorders like diabetes, cardiac failure, or renal failure; willing to stay in the hospital for the initial 1‐month intensive phase of treatment

Exclusion criteria: not stated

Interventions

Intervention of interest:

  • Defaulter reminder letter to the correct home address on the 4th day of the due date. The second defaulter action became due only when the first action failed to retrieve the patient, and it would be posted on the 8th day after the first action.

Control:

  • No reminder letter.

Outcomes

Outcomes included in this review:

  • Treatment completion.

Outcomes not included in this review:

  • Treatment default: defined as number of patients failed to collect the drugs within three days after the due date of drug collection.

  • Defaulters retrieval: defined as number of defaulters retrieved.

Notes

Location: South India

Trial dates: not specified

Baseline data: not reported

Funding: the Scientific Committee of Anti‐tuberculosis Association of Tamilnadu

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random‐numbers table (confirmed by the trial authors).

Allocation concealment (selection bias)

Low risk

Centralized randomization by a third party (confirmed by the trial authors).

Blinding of outcome assessment (detection bias)
All outcomes

High risk

No blinding of outcome assessment.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

200/200 (100%), no missing data.

Selective reporting (reporting bias)

Low risk

All relevant outcomes in the methods section are reported in the results section.

Other bias

Low risk

None identified.

Roberts 1983a

Methods

Trial design: RCT

Participants

Number of participants: 200 randomized

Inclusion criteria: volunteers who participated in a university‐sponsored TB detection drive; mostly college students

Exclusion criteria: not stated

Interventions

Intervention of interest:

  • Take‐home reminder card.

  • Postcard reminder.

  • Pre‐appointment telephone call.

Control:

  • Direct person‐to‐person reminder.

Outcomes

Outcomes included in this review:

  • Number of participants who return for skin‐test reading.

Outcomes not included in this review : None.

Notes

Location: USA

Trial dates: not specified

Baseline data: comparable

Funding: Research Grants Committee, University of Alabama

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Only described as "randomised".

Allocation concealment (selection bias)

Unclear risk

Only described as "randomised".

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

200/200 (100%), no missing data.

Selective reporting (reporting bias)

Low risk

All relevant outcomes in the methods section are reported in the results section.

Other bias

Low risk

None identified.

Roberts 1983b

Methods

Trial design: RCT

Participants

Number of participants: 553 randomized

Inclusion criteria: volunteers who participated in a university‐sponsored TB detection drive

Exclusion criteria: not stated

Interventions

Intervention of interest:

  • Take‐home reminder card with or without enhanced message on the importance of returning, and with or without three types of overt commitment to return.

Control:

  • No reminder card.

Outcomes

Outcomes included in this review:

  • Number of participants who return for skin‐test reading.

Outcomes not included in this review : None.

Notes

Location: USA

Trial dates: not specified

Baseline data: comparable

Funding: Research Grants Committee, University of Alabama

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Only described as "randomised".

Allocation concealment (selection bias)

Unclear risk

Only described as "randomised".

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

553/553 (100%), no missing data.

Selective reporting (reporting bias)

Low risk

All relevant outcomes in the methods section are reported in the results section.

Other bias

Low risk

None identified.

Salleras Sanmarti 1993

Methods

Trial design: RCT

Participants

Number of participants: 318 randomized

Inclusion criteria: school children of both sexes in the first year of primary school in state‐run and private schools in the provinces of Barcelona, on anti‐TB chemoprophylaxis

Exclusion criteria: children with active TB confirmed by medical examination and chest x‐ray

Interventions

Intervention of interest:

  • Phone call reminder: Childrens' mothers were telephoned by a specialized nursing personnel every 3 months who informed them of the advantages of chemoprophylaxis for their child's health and encouraged them to continue with this preventive measure.

  • Home visit reminder: Specialized nurse went to the patient's home every 3 months providing health education to the mother and child, encouraging them to continue with the preventive therapy, and giving them the same information leaflets given at the first visit.

  • Child was seen by the physician every 3 months at the TB Prevention and Control Centre, providing health education and leaflets at each visit.

Control:

  • No health education activity performed.

Outcomes

Outcomes included in this review:

  • Adherence to final appointment.

Outcomes not included in this review:

  • Negative Eidus‐Hamilton reaction.

Notes

Location: Spain

Trial dates: academic year 1985 to 1986

Baseline data: not reported

Funding: not reported

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Only described as "randomised".

Allocation concealment (selection bias)

Unclear risk

Only described as "randomised".

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified.

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

275/318 (86.5%); 43/318 (13.5%) withdrew from treatment, but number withdrew from each group not stated, nor reasons for missing data provided.

Selective reporting (reporting bias)

Low risk

All relevant outcomes in the methods section are reported in the results section.

Other bias

Low risk

None identified.

Tanke 1994

Methods

Trial design: Quasi‐RCT

Participants

Number of participants: 2008 randomized

Inclusion criteria: patients with scheduled appointments in the Tuberculosis Control Program of Santa Clara County Health Department over a period of 6 months

Exclusion criteria: not stated

Interventions

Intervention of interest:

  • Basic reminder: pre‐recorded message (TeleMinder system) from the county health department; identified the patient by name, indicated that the patient had an appointment the following day, and gave the address and phone number of the clinic twice; message could be repeated by remaining on the line; message did not refer to TB.

  • Basic reminder plus authority endorsement: identified the Public Health Nurse at the Health Department as the source of the message.

  • Basic reminder plus importance statement: following statement was inserted after the basic information: "Coming to this appointment is important so that you and your family will not become seriously ill."

  • Basic reminder plus importance statement plus authority endorsement.

Control:

  • No message.

Appropriate recorded message was sent to patients between 18.00 and 21.00 the evening before the scheduled appointment. The system allows a message to be left on answering machines and to call back up to 5 times at half‐hour intervals if patients' lines were busy or there was no answer after 8 rings. For households whose primary language was English, Spanish, Vietnamese, or Tagalog, the message was sent in that language.

Outcomes

Outcomes included in this review:

  • Attendance for a scheduled appointment: if a patient had > 1 appointment during the course of the trial, only data from the first appointment were included.

Outcomes not included in this review :

  • Patient attitudes toward automated reminders.

Notes

Location: USA

Trial dates: not specified

Baseline data: not reported

Funding: SBIR grants #2 R44 AI31750‐02 from the National Institute of Allergy and Infectious Diseases and #1 R43 AG10659‐01 from the National Institute on Aging

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Within each 5‐week period each message variation was used once on each weekday, different variations were used each day of a given week by a computer‐generated system.

Allocation concealment (selection bias)

High risk

Sequential allocation.

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not specified.

Incomplete outcome data (attrition bias)
All outcomes

Low risk

2008/2008 (100%), no missing data.

Selective reporting (reporting bias)

Low risk

All relevant outcomes in the methods section are reported in the results section.

Other bias

Low risk

None identified.

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Ailinger 2010

Pre‐experimental design with historical comparison, cultural intervention with no reminder.

Akhtar 2011

Clinic DOT versus family DOT, did not mention the intervention of interest.

Al‐Hajjaj 2000

Case‐control study design.

Alcaide Megías 1990

Intervention did not include reminders.

Alvarez Gordillo 2003

Intervention did not include reminders.

Atkins 2011

Enhanced Tuberculosis Adherence (ETA) model versus DOT, ETA is a complex intervention contains treatment supporter visits but the results cannot be disaggregated.

Barclay 2009

Report.

Bordley 2001

Most participants did not have need for screening, prophylaxis or treatment for TB, and results for the individuals in these categories were not presented separately.

Bronner 2012

A retrospective study using routinely collected data from the South African national database for TB surveillance.

Grant 2010

Description on community education and mobilization of a TB preventive programme, reminder is not a main component of the integrated intervention package.

Hovell 2003

Intervention did not include reminders.

Hsieh 2007

The study evaluated case management that includes in‐hospital direct supervision plus a home visit on discharge.

Hunchangsith 2010

Conference research abstracts.

Hunchangsith 2012

Treatment outcomes from the mobile phone intervention were derived from a case study.

Iribarren 2013

A pilot randomized trial evaluating the acceptance, feasibility and initial efficacy of a text messaging intervention to support TB treatment adherence. The intervention was more of a notification system (by the patient) of drug intake and an educational intervention rather than a reminder system.

Jin 1993

Intervention did not include reminders.

Krishna 2002

Review article.

Lin 2006

Cohort study design.

Morisky 1990

Intervention did not include reminders, except for those routinely provided and also applied to the control group.

Morisky 2001

Intervention did not include reminders.

Nyamathi 2007

Process of reminders not described and the main objective was to assess predictors of latent TB infection completion by using structural equation modelling among homeless adults.

Sanneh 2010

Cross‐sectional study.

Tanke 1997

A RCT compared a pre‐recorded telephone reminder message (TeleMinder system) twice with no reminder message. It only reported the percentages of participants returned for skin test reading without the events and numbers of each groups. We contacted with the authors but got no feedback.

Thiam 2007

Reminders not adequately described or systematically applied.

Tokzek 2012

Review article.

Yusuf 2011

Conference research abstracts.

Characteristics of ongoing studies [ordered by study ID]

CTRI/2011/07/001889

Trial name or title

The development and evaluation of m‐Health service in the control of tuberculosis (TB) in India ‐ TIMTAM trial

Methods

Study design: randomized; sequentially numbered, sealed, opaque envelopes; participant and outcome assessor blinded

Inclusion criteria:

  1. Owns a mobile phone and can read text messages.

  2. Person with confirmed TB ( smear, or culture, or both).

  3. Person having both TB and HIV disease.

  4. Should be able to sign an informed consent.

Exclusion criteria: Not able to sign the informed consent document.

Participants

Target sample size: 500

Interventions

DOTS Plus mHealth: Patients in arm A (DOTS plus m‐Health) will receive three text (SMS) messages every week for the duration of their treatment as a part of the trial. Patients will be provided with a card containing contact details for a telephone help line (24‐hour help line), with clear instructions that this can be used, free of charge, when access to face to face consultation is not available and medical advice is required.

Outcomes

Primary:

  1. Treatment adherence rates.

  2. Timepoint: Baseline, 3, and 6 months.

Secondary:

  1. Treatment completion and cure rates.

  2. Treatment success rates.

  3. Adverse drug reaction rates.

  4. Stigma associated with TB (measured by a validated survey).

  5. Patient satisfaction (measured by a validated survey).

  6. Usage of the m‐Health initiative.

Timepoint: Baseline, 3, and 6 months

Starting date

Date of registration: 14 July 2011

Date of first enrolment: 1 September 2011

Last refreshed on: 3 February 2014

Recruitment status: Not yet recruiting

Contact information

URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2883

Dilip Mathai

IDTRC IV Floor SP Complex Ida

Scudder Road Vellore

Vellore, TAMIL NADU, 632004, India

Notes

Study ID: CTRI/2011/07/001889
Register: ClinicalTrials.gov

Location: India
Source of funding: School of Public Health and Community Medicine University of New South Wales

ISRCTN46846388

Trial name or title

Cluster randomized trial of using mobile text messaging and a medication monitor in tuberculosis (TB) case management

Methods

Study design: Cluster randomized non‐blinded controlled trial

Inclusion criteria:

  1. TB patients, smear‐positive or smear‐negative, recruited from the study clusters (county/district).

  2. Willing to participate in the study.

  3. Conscious without any mental disease.

  4. Conscious without any visual, auditory, or language impairment.

  5. At least 18 years old.

  6. Patient or family member is able to read a SMS text messages and use medication monitor after training.

Exclusion criteria:

  1. Does not meet inclusion criteria.

  2. Patients with TB pleurisy.

  3. Patients with no sputum smear data at TB diagnosis.

Participants

Target sample size: 4176 participants (116 per cluster; 9 clusters per arm; 4 arms); age minimum: N/A; age maximum: N/A; gender: N/A

Interventions

  1. Mobile phone reminder.

  2. Medication monitor.

  3. Mobile phone and medication monitor.

Outcomes

Primary:

  1. The mean proportion of months a patient has at least 3 doses missed (this is based on pill count data from the medication monitor box).

Secondary:

  1. The mean proportion of months a patient has at least 7 doses missed.

  2. The mean proportion of overall missed doses.

  3. Proportion of patients defined as non‐adherent (at least 10% of doses missed).

  4. Proportion of patients defaulting during TB treatment.

  5. Proportion of smear positive TB cases who become smear negative at 2 months.

  6. The proportion of patients with treatment outcome of cure or completed treatment.

Starting date

Date of registration: 21 July 2011

Last refreshed on: 20 January 2014

Date of first enrolment: 1 June 2011

Recruitment status: Completed/not recruiting

Contact information

URL:http://isrctn.org/ISRCTN46846388

Shiwen Jiang

China Center for Disease Control and Prevention No. 155 Changbai Road Changping District 102206 Beijing China

Notes

Study ID: ISRCTN46846388

Register: ISRCTN

Location: China
Source of funding: Bill and Melinda Gates Foundation (Grant ref: 51914)

NCT01471977

Trial name or title

Interventions to promote adherence to tuberculosis treatment among patients attending basic medical unit of Taluka Gambat, Pakistan

Methods

Study design: Non‐randomized, single group assignment, open label

Inclusion criteria:

  1. Adult patient.

  2. > 18 years.

  3. Either sex.

  4. Diagnosed to have TB through chest x ray or sputum microscopy.

  5. Eligible to participate in the study.

Participants

Target sample size: 1280 participants; age minimum: 18 years; age maximum: N/A; gender: both

Interventions

Education, counselling, default tracers, quality of care

Outcomes

Primary:

  1. Proportion of patients completed treatment (time frame: 8 months).

  2. Proportion of patients cured (time frame: 8 months).

  3. Proportion of patients defaulted (time frame: 8 months).

  4. Proportion of patients died (time frame: 8 months).

  5. Proportion of patients transferred out (time frame: 8 months).

  6. Proportion of patients with treatment failure (time frame: 8 months).

Starting date

Date of registration: 4 November 2011

Date of first enrolment: January 2004

Last refreshed on: 17 October 2012

Recruitment status: Completed

Contact information

URL:http://clinicaltrials.gov/show/NCT01471977

Nisar Sheikh

Gambat Institute of Medical Sciences

Notes

Study ID: NCT01471977
Register: ClinicalTrials.gov

Location: Pakistan
Source of funding:Gambat Institute of Medical Sciences

NCT01549457

Trial name or title

A randomized controlled trial to examine the effectiveness of use of mobile phones and text messaging to improve adherence to treatment of latent TB

Methods

Study design: Randomized, single group assignment, open label

Inclusion criteria:

  1. Are initiating treatment for latent TB infection.

  2. Are over the age of 18 years old.

  3. Own a mobile phone or share access mobile phone access with a household member who consents to participate.

  4. Demonstrate sufficient ability to communicate via text messaging in English or have a family member or friend that is able to provide translation and assistance with text messaging for the duration of the study.

Exclusion criteria:

  1. Individuals under the age of 18.

  2. Unable to adequately send and receive text messages for any reason.

  3. Enrolled in another clinical trial that may assess or influence treatment adherence.

Participants

Target sample size: 486 participants; age minimum: 19 years; age maximum: N/A; gender: both

Interventions

Cell phone text messages

Outcomes

Primary:

  1. Successful completion of LTBI treatment regimens (time frame: 4 or 9 months).

Starting date

Date of registration: 6 March 2012

Last refreshed on: 10 February 2014

Date of first enrolment: April 2012

Recruitment status: Recruiting

Contact information

URL:http://clinicaltrials.gov/show/NCT01549457

Dr. Richard Lester

BC Centre for Disease Control

Canada

Notes

Study ID: NCT01549457

Register: ClinicalTrials.gov

Location: Canada
Source of funding: University of British Columbia

NCT01690754

Trial name or title

Evaluating the effectiveness of interactive SMS reminders on TB drug compliance and treatment

Methods

Study design: Randomized, parallel assignment, open label

Inclusion criteria:

  1. New, smear‐positive drug susceptible TB who have been on treatment for less than two weeks.

  2. Access to a mobile phone (self‐reported).

  3. Intending to reside in Karachi for the duration of their treatment.

Exclusion criteria:

  1. Patients who do not have regular access to a mobile phone.

  2. Patients who have previously received TB treatment.

  3. Patients who have another member in their household who is already a part of the study.

Participants

Target sample size: 2200 participants; age minimum: 15 years; age maximum: N/A; gender: both

Interventions

Interactive reminders

Outcomes

Primary:

  1. Sputum conversion (time frame: at 2, 5, and 6 or 7 months of treatment).

  2. Treatment compliance (time frame: monthly visits for 6 to 8 months of treatment).

  3. Treatment outcomes (time frame: after 6 to 8 months of treatment).

Secondary:

  1. Physical fitness and mobility (time frame: monthly visits for 6 to 8 months of treatment).

  2. Psychological Impacts (time frame: monthly visits for 6 to 8 months of treatment).

  3. Treatment Compliance (time frame: monthly visits for 6 to 8 months of treatment).

Starting date

Date of registration: 13 September 2012

Date of first enrolment: March 2011

Last refreshed on: 17 October 2012

Recruitment status: Recruiting

Contact information

URL:http://clinicaltrials.gov/show/NCT01690754

Shama Mohammed

Interactive Research and Development

Notes

Study ID: NCT01690754
Register: ClinicalTrials.gov

Location: Pakistan
Source of funding: Interactive Research and Development; Massachusetts Institute of Technology

NCT02082340

Trial name or title

Innovative approach in tuberculosis care in Armenia

Methods

Study design: Randomized, efficacy study, parallel assignment, open label

Inclusion criteria:

  1. Diagnosis of drug‐sensitive TB.

  2. Age 18 years old and above.

  3. Understanding and reading in Armenian.

  4. Completion of the intensive treatment phase.

Exclusion criteria:

  1. Involvement in the home‐based TB treatment programme of the National TB Control Office.

Participants

Target sample size: 400 participants; age minimum: 18 years; age maximum: N/A; gender: both

Interventions

Self‐administered drug intake strategy, TB knowledge and socio‐psychological counselling session, SMS text messages, phone calls, educational leaflet

Outcomes

Primary:

  1. TB treatment success rates (time frame: patients will be followed for the duration of ambulatory phase of treatment, an expected average of 4 months).

Secondary:

  1. Depression status of TB patients.

  2. Family support towards TB patients.

  3. Knowledge about TB infection.

  4. Quality of life of TB patients.

  5. Stigma level towards TB patients.

  6. TB treatment adherence.

Time frame: At baseline, 1, and 3 months after starting the ambulatory phase of the treatment and upon completion of the treatment (an expected average of 4 months after starting the ambulatory phase of the treatment)

Starting date

Date of registration: 4 March 2014

Date of first enrolment: March 2014

Last refreshed on: 31 March 2014

Recruitment status: Active, not recruiting

Contact information

URL:http://clinicaltrials.gov/show/NCT02082340

Varduhi Petrosyan

American University of Armenia Fund

Notes

Study ID: NCT02082340
Register: ClinicalTrials.gov

Location: Armenia
Source of funding: Grand Challenges Canada

PACTR201307000583416

Trial name or title

Evaluation of therapeutic adherence support by SMS on the cure rate of tuberculosis: a protocol of a randomized control study

Methods

Study design: Randomized, parallel assignment

Inclusion criteria:

  1. Must be new smear positive PTB.

  2. To have at least 18 years (born before 1st January 1995).

  3. The patient must know how to read French or English.

  4. Have a mobile phone number for personal use.

  5. Know how to open and read an SMS on his telephone.

  6. Give his consent (signed on the informed consent form).

Exclusion criteria

  1. Hospitalized or severely ill patient as identified by health staff.

Participants

Target sample size: 260 participants; age minimum: 18 years; age maximum: 60 years; gender: both

Interventions

SMS

Outcomes

Primary:

  1. The cure rate at 6 months in the groups.

Secondary:

  1. The degree of satisfaction.

  2. The rate of treatment adherence (regularity in the respect of prescriptions and the percentage of prescribed doses taken).

  3. Treatment failure.

Starting date

Date of registration: 5 July 2013

Last refreshed on: 3 February 2014

Date of first enrolment: 21 February 2013

Recruitment status: Open to recruitment: actively recruiting participants

Contact information

URL: http://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?dar=true&tNo=PACTR201307000583416

Jean‐Louis Abena

Programme, Ministry of Public Health, Cameroon

Notes

Study ID: PACTR201307000583416

Register: PACTR

Location: South Africa
Source of funding: Geneva University Hospital

Data and analyses

Open in table viewer
Comparison 1. TB treatment: reminder versus none

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Attendance at single clinic appointment Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 TB treatment: reminder versus none, Outcome 1 Attendance at single clinic appointment.

Comparison 1 TB treatment: reminder versus none, Outcome 1 Attendance at single clinic appointment.

1.1 Pre‐appointment phone call

1

615

Risk Ratio (M‐H, Random, 95% CI)

1.32 [1.10, 1.59]

1.2 Defaulter reminder letter

1

52

Risk Ratio (M‐H, Random, 95% CI)

5.04 [1.61, 15.78]

2 TB cure or treatment completion Show forest plot

3

778

Risk Ratio (M‐H, Random, 95% CI)

1.17 [1.11, 1.23]

Analysis 1.2

Comparison 1 TB treatment: reminder versus none, Outcome 2 TB cure or treatment completion.

Comparison 1 TB treatment: reminder versus none, Outcome 2 TB cure or treatment completion.

2.1 Pre‐appointment phone call

1

98

Risk Ratio (M‐H, Random, 95% CI)

1.14 [1.02, 1.27]

2.2 Defaulter reminder letter or home visit

2

680

Risk Ratio (M‐H, Random, 95% CI)

1.17 [1.11, 1.24]

Open in table viewer
Comparison 2. TB treatment: comparison of different reminders

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Attendance at single clinic appointment Show forest plot

1

121

Risk Ratio (M‐H, Fixed, 95% CI)

1.12 [0.87, 1.45]

Analysis 2.1

Comparison 2 TB treatment: comparison of different reminders, Outcome 1 Attendance at single clinic appointment.

Comparison 2 TB treatment: comparison of different reminders, Outcome 1 Attendance at single clinic appointment.

2 TB cure or treatment completion Show forest plot

1

150

Risk Ratio (M‐H, Fixed, 95% CI)

1.2 [0.95, 1.51]

Analysis 2.2

Comparison 2 TB treatment: comparison of different reminders, Outcome 2 TB cure or treatment completion.

Comparison 2 TB treatment: comparison of different reminders, Outcome 2 TB cure or treatment completion.

Open in table viewer
Comparison 3. TB prophylaxis: reminder versus none

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Attendance at single clinic appointment Show forest plot

1

536

Risk Ratio (M‐H, Fixed, 95% CI)

1.30 [1.07, 1.59]

Analysis 3.1

Comparison 3 TB prophylaxis: reminder versus none, Outcome 1 Attendance at single clinic appointment.

Comparison 3 TB prophylaxis: reminder versus none, Outcome 1 Attendance at single clinic appointment.

2 Attendance at final clinic appointment Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 3.2

Comparison 3 TB prophylaxis: reminder versus none, Outcome 2 Attendance at final clinic appointment.

Comparison 3 TB prophylaxis: reminder versus none, Outcome 2 Attendance at final clinic appointment.

2.1 Routine phone call every three months

1

157

Risk Ratio (M‐H, Random, 95% CI)

1.44 [1.21, 1.72]

2.2 Routine nurse home visit every three months

1

156

Risk Ratio (M‐H, Random, 95% CI)

1.46 [1.23, 1.74]

2.3 Routine doctor clinic every three months

1

159

Risk Ratio (M‐H, Random, 95% CI)

1.20 [0.98, 1.47]

Open in table viewer
Comparison 4. Skin test reading: reminder versus none

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Attendance at single clinic appointment Show forest plot

4

1900

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.92, 1.10]

Analysis 4.1

Comparison 4 Skin test reading: reminder versus none, Outcome 1 Attendance at single clinic appointment.

Comparison 4 Skin test reading: reminder versus none, Outcome 1 Attendance at single clinic appointment.

1.1 Take home reminder card

2

711

Risk Ratio (M‐H, Random, 95% CI)

0.96 [0.88, 1.04]

1.2 Pre‐appointment phone call

3

1189

Risk Ratio (M‐H, Random, 95% CI)

1.06 [0.92, 1.21]

Open in table viewer
Comparison 5. Skin test reading: comparison of different reminders

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Attendance at single clinic appointment Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

Analysis 5.1

Comparison 5 Skin test reading: comparison of different reminders, Outcome 1 Attendance at single clinic appointment.

Comparison 5 Skin test reading: comparison of different reminders, Outcome 1 Attendance at single clinic appointment.

1.1 Take‐home card versus postcard

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Take‐home card versus telephone call

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Postcard versus telephone call

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials.

Risk of bias summary: review authors' judgements about each risk of bias item for each included trial.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included trial.

Comparison 1 TB treatment: reminder versus none, Outcome 1 Attendance at single clinic appointment.
Figuras y tablas -
Analysis 1.1

Comparison 1 TB treatment: reminder versus none, Outcome 1 Attendance at single clinic appointment.

Comparison 1 TB treatment: reminder versus none, Outcome 2 TB cure or treatment completion.
Figuras y tablas -
Analysis 1.2

Comparison 1 TB treatment: reminder versus none, Outcome 2 TB cure or treatment completion.

Comparison 2 TB treatment: comparison of different reminders, Outcome 1 Attendance at single clinic appointment.
Figuras y tablas -
Analysis 2.1

Comparison 2 TB treatment: comparison of different reminders, Outcome 1 Attendance at single clinic appointment.

Comparison 2 TB treatment: comparison of different reminders, Outcome 2 TB cure or treatment completion.
Figuras y tablas -
Analysis 2.2

Comparison 2 TB treatment: comparison of different reminders, Outcome 2 TB cure or treatment completion.

Comparison 3 TB prophylaxis: reminder versus none, Outcome 1 Attendance at single clinic appointment.
Figuras y tablas -
Analysis 3.1

Comparison 3 TB prophylaxis: reminder versus none, Outcome 1 Attendance at single clinic appointment.

Comparison 3 TB prophylaxis: reminder versus none, Outcome 2 Attendance at final clinic appointment.
Figuras y tablas -
Analysis 3.2

Comparison 3 TB prophylaxis: reminder versus none, Outcome 2 Attendance at final clinic appointment.

Comparison 4 Skin test reading: reminder versus none, Outcome 1 Attendance at single clinic appointment.
Figuras y tablas -
Analysis 4.1

Comparison 4 Skin test reading: reminder versus none, Outcome 1 Attendance at single clinic appointment.

Comparison 5 Skin test reading: comparison of different reminders, Outcome 1 Attendance at single clinic appointment.
Figuras y tablas -
Analysis 5.1

Comparison 5 Skin test reading: comparison of different reminders, Outcome 1 Attendance at single clinic appointment.

Summary of findings for the main comparison. Summary of findings table 1

TB treatment: pre‐appointment reminder versus no reminder

Patient or population: People on TB treatment
Settings: Outpatient clinic
Intervention: Pre‐appointment reminder
Comparison: No reminder

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(trials)

Quality of the evidence
(GRADE)

Assumed risk

Corresponding risk

No reminder

Pre‐appointment reminder

Attendance at single clinic appointment

50 per 100

66 per 100

(55 to 80)

RR 1.32

(1.10 to 1.59)

615
(1 trial)

⊕⊕⊝⊝

low1,2

Completion of TB treatment

88 per 100

100 per 100

(90 to 100)

RR 1.14

(1.02 to 1.27)

92
(1 trial)

⊕⊕⊝⊝

low3,4,5

The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Downgraded by 1 for serious risk of bias: This trial was quasi‐randomized and is at high risk of selection bias.
2Downgraded by 1 for serious indirectness: Clinic attendance in this single trial from the USA is very low. It is unclear whether DOTS was implemented at the trial site, and the findings may not be easily generalizable elsewhere
3Downgraded by 1 for serious risk of bias: No details of randomization are provided and the risk of selection bias.
4Downgraded by 1 for serious imprecision: This trial is very underpowered to detect this effect.
5No serious indirectness: This is a single trial of pre‐appointment phone call reminders in adults from Thailand where DOTS was being implemented. Although its findings may not be easily generalized to all settings, it is likely to be similar to TB‐endemic settings in developing countries.

Figuras y tablas -
Summary of findings for the main comparison. Summary of findings table 1
Summary of findings 2. Summary of findings table 2

TB treatment: defaulter reminder versus no reminder

Patient or population: People on TB treatment
Settings: Outpatient clinic
Intervention: Default reminder
Comparison: No reminder

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(trials)

Quality of the evidence
(GRADE)

Assumed risk

Corresponding risk

No reminder

Defaulter reminder

Attendance at single clinic appointment

10 per 100

52 per 100

(17 to 100)

RR 5.04
(1.61 to 15.78)

52

(1 trial)

⊕⊕⊝⊝
low1,2,3

Completion of TB treatment

78 per 100

91 per 100
(87 to 97)

RR 1.17
(1.11 to 1.24)

680
(2 trials)

⊕⊕⊕⊝
moderate4,5,6,7

The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1No serious risk of bias: This trial was at low risk of selection bias, but was unblinded.
2Downgraded by 1 for serious indirectness: This outcome was only reported from a single trial setting in India where DOTS was not implemented and attendance at clinic was very low. The result may not be easily generalizable elsewhere.
3Downgraded by 1 for serious imprecision: This trial was underpowered to confidently detect clinically important effects.
4No serious risk of bias: Both trials were at low risk of selection bias.
5No serious inconsistency: This finding was consistent across trials.
6Downgraded by 1 for serious indirectness: The two trials were conducted in Iraq and India and DOTS was only implemented in the Iraq trial. One trial used home visits and one used reminder letters. The findings may not be easily generalized to all settings, and interventions may need adapting to the local context.
7No serious imprecision: The trials are adequately powered to detect this effect.

Figuras y tablas -
Summary of findings 2. Summary of findings table 2
Summary of findings 3. Summary of findings table 3

TB skin testing: pre‐appointment reminder versus no reminder

Patient or population: People at risk of TB
Settings: Outpatient clinic
Intervention: Pre‐appointment reminder
Comparison: No reminder

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(trials)

Quality of the evidence
(GRADE)

Assumed risk

Corresponding risk

No reminder

Pre‐appointment reminder

Attendance at clinic

60 per 100

63 per 100
(55 to 72)

RR 1.06
(0.92 to 1.21)

1189
(3 trials)

⊕⊕⊝⊝
low1,2

The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Downgraded by 1 for serious risk of bias: Two trials are quasi‐RCTs and at high risk of selection bias. The third provides few details of randomization and is at unclear risk.
2Downgraded by 1 for serious indirectness: All three trials were conducted in the USA between 1983 and 1997, and the results may not be easily generalized to elsewhere.

Figuras y tablas -
Summary of findings 3. Summary of findings table 3
Table 1. Detailed search strategies

Search set

Cochrane SRa

CENTRAL

MEDLINEb

EMBASEb

LILACSb

SCI‐EXPANDED & SSCI

CINAHL

1

tuberculosis

tuberculosis

tuberculosis

tuberculosis

tuberculosis

tuberculosis

tuberculosis

2

adherence

PATIENT COMPLIANCE

TUBERCULOSIS/DRUG THERAPY/PREVENTION AND CONTROL

TUBERCULOSIS

adherence

adherence

adherence

3

compliance

PATIENT DROPOUTS

PATIENT COMPLIANCE

PATIENT‐COMPLIANCE

compliance

compliance

compliance

4

monitor*

REMINDER SYSTEMS

PATIENT DROPOUTS

medication adherence

Monitor$

monitor*

monitor*

5

reminder*

TREATMENT REFUSAL

COOPERATIVE BEHAVIOUR

REMINDER‐SYSTEM

Reminder$

reminder*

reminder*

6

phone or SMS* or text or messaging

DIRECTLY OBSERVED THERAPY

TREATMENT REFUSAL

TREATMENT‐REFUSAL

phone or SMS$ or text or messaging

non‐adherence

non‐adherence

7

2 or 3 or 4 or 5 or 6

medication adherence

medication adherence

DIRECTLY‐OBSERVED‐THERAPY

2 or 3 or 4 or 5 or 6

late patient tracer

late patient tracer

8

1 and 7

electronic monitoring

REMINDER SYSTEMS

electronic monitoring

1 and 7

phone or SMS* or text or messaging

phone or SMS* or text or messaging

9

nonadherence

electronic monitoring

nonadherence

2‐8/OR

2‐8/OR

10

non‐adherence

nonadherence

non‐adherence

1 AND 9

1 AND 9

11

late patient tracer

non‐adherence

late patient tracer

12

phone or SMS* or text or messaging

DIRECTLY OBSERVED THERAPY

phone or SMS* or text or messaging

13

2‐12

late patient tracer

1 or 2

14

1 AND 13

phone or SMS* or text or messaging

3‐12/OR

15

1 or 2

13 and 14

16

3‐14/OR

17

15 and 16

aCochrane Infectious Diseases Group Specialized Register and the Cochrane Effective Practice and Organisation of Care Group Specialized Register.
bSearch terms used in combination with the search strategy for retrieving trials developed by The Cochrane Collaboration (Lefebvre 2011). For controlled "before and after" studies, we used the terms: "before and after"; time series analysis; cohort analysis; controlled study. Upper case: MeSH or EMTREE heading; lower case: free text term.

Figuras y tablas -
Table 1. Detailed search strategies
Table 2. Summary of populations and interventions

Trial ID

Country

Age group

TB status

TB intervention

Supervision of treatment

Type of reminder

Timing of reminder

Pre/post appointment

Control

Roberts 1983b

USA

Adults

At risk of TB

Test

N/A

Take home reminder card1

N/A

N/A

Verbal statement in clinic

Roberts 1983a

USA

Adults

At risk of TB

Test

N/A

Take home reminder card2

N/A

N/A

Verbal statement in clinic

N/A

Postcard

1 day

Pre‐appointment

Verbal statement in clinic

N/A

Phone call

1 day

Pre‐appointment

Verbal statement in clinic

Tanke 1994

USA

All

At risk of TB

Test

N/A

Phone call3

1 day

Pre‐appointment

No phone call

Cheng 1997

USA

Children

At risk of TB

Test

N/A

Phone call

1 day

Pre‐appointment

Take home reminder card

Salleras Sanmarti 1993

Spain

Children

Asymptomatic

Prophylaxis

Parents

A routine phone call every 3 months

N/A

N/A

One‐off advice to take treatment for 12 months

A routine nurse home visit every 3 months

N/A

N/A

One‐off advice to take treatment for 12 months

A routine doctor clinic appointment every 3 months

N/A

N/A

One‐off advice to take treatment for 12 months

Tanke 1994

USA

All

Asymptomatic

Prophylaxis

Unclear

Phone call3

1 day

Pre‐appointment

No phone call

Tanke 1994

USA

All

Symptomatic

Treatment

Unclear

Phone call3

1 day

Pre‐appointment

No phone call

Kunawararak 2011

Thailand

> 15 years

Symptomatic

Treatment

DOTS

Phone call

1 day

Pre‐appointment

DOTS alone

Mohan 2003

Iraq

Not stated

Symptomatic

Treatment

DOTS

Home visit

3 days

Post‐appointment

DOTS alone

Krishnaswami 1981

India

> 12 years

Symptomatic

Treatment

Self‐monthly pick‐up of meds

Home visit

4 days

Post‐appointment

Reminder letter

Paramasivan 1993

India

Adult

Symptomatic

Treatment

Self‐monthly pick‐up of meds

Reminder card

3 days

Post‐appointment

No reminder card

1Roberts 1983b also evaluated the effects of three types of participant commitment to return (no commitment, verbal, verbal plus written), and two types of verbal messaging on the importance of returning (enhanced versus standard).
2Roberts 1983aalso evaluated the effect of two types of verbal messaging on the importance of returning (expert versus non‐expert).
3Tanke 1994 evaluated four different automated phone messages: basic message, message with authority, message with importance, and message with authority and importance. No differences were seen between the different messages.

Figuras y tablas -
Table 2. Summary of populations and interventions
Table 3. Optimal information size calculations

Outcome

Hypothesis

Power

α error

Proportion in control group

Proportion in intervention group

Total sample size required

Attendance at clinic appointment

Superiority

80%

5%

50%

75%

110

80%

90%

394

TB cure or treatment completion

Superiority

80%

5%

50%

75%

110

80%

90%

394

We performed calculations using http://www.sealedenvelope.com

Figuras y tablas -
Table 3. Optimal information size calculations
Comparison 1. TB treatment: reminder versus none

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Attendance at single clinic appointment Show forest plot

2

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 Pre‐appointment phone call

1

615

Risk Ratio (M‐H, Random, 95% CI)

1.32 [1.10, 1.59]

1.2 Defaulter reminder letter

1

52

Risk Ratio (M‐H, Random, 95% CI)

5.04 [1.61, 15.78]

2 TB cure or treatment completion Show forest plot

3

778

Risk Ratio (M‐H, Random, 95% CI)

1.17 [1.11, 1.23]

2.1 Pre‐appointment phone call

1

98

Risk Ratio (M‐H, Random, 95% CI)

1.14 [1.02, 1.27]

2.2 Defaulter reminder letter or home visit

2

680

Risk Ratio (M‐H, Random, 95% CI)

1.17 [1.11, 1.24]

Figuras y tablas -
Comparison 1. TB treatment: reminder versus none
Comparison 2. TB treatment: comparison of different reminders

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Attendance at single clinic appointment Show forest plot

1

121

Risk Ratio (M‐H, Fixed, 95% CI)

1.12 [0.87, 1.45]

2 TB cure or treatment completion Show forest plot

1

150

Risk Ratio (M‐H, Fixed, 95% CI)

1.2 [0.95, 1.51]

Figuras y tablas -
Comparison 2. TB treatment: comparison of different reminders
Comparison 3. TB prophylaxis: reminder versus none

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Attendance at single clinic appointment Show forest plot

1

536

Risk Ratio (M‐H, Fixed, 95% CI)

1.30 [1.07, 1.59]

2 Attendance at final clinic appointment Show forest plot

1

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2.1 Routine phone call every three months

1

157

Risk Ratio (M‐H, Random, 95% CI)

1.44 [1.21, 1.72]

2.2 Routine nurse home visit every three months

1

156

Risk Ratio (M‐H, Random, 95% CI)

1.46 [1.23, 1.74]

2.3 Routine doctor clinic every three months

1

159

Risk Ratio (M‐H, Random, 95% CI)

1.20 [0.98, 1.47]

Figuras y tablas -
Comparison 3. TB prophylaxis: reminder versus none
Comparison 4. Skin test reading: reminder versus none

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Attendance at single clinic appointment Show forest plot

4

1900

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.92, 1.10]

1.1 Take home reminder card

2

711

Risk Ratio (M‐H, Random, 95% CI)

0.96 [0.88, 1.04]

1.2 Pre‐appointment phone call

3

1189

Risk Ratio (M‐H, Random, 95% CI)

1.06 [0.92, 1.21]

Figuras y tablas -
Comparison 4. Skin test reading: reminder versus none
Comparison 5. Skin test reading: comparison of different reminders

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Attendance at single clinic appointment Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 Take‐home card versus postcard

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Take‐home card versus telephone call

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Postcard versus telephone call

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 5. Skin test reading: comparison of different reminders