Fraud in a population-based study of headache: prevention, detection and correction.

BACKGROUND: In medicine, research misconduct is historically associated with laboratory or pharmaceutical research, but the vulnerability of epidemiological surveys should be recognized. As these surveys underpin health policy and allocation of limited resources, misreporting can have far-reaching implications. We report how fraud in a nationwide headache survey occurred and how it was discovered and rectified before it could cause harm. METHODS: The context was a door-to-door survey to estimate the prevalence and burden of headache disorders in Pakistan. Data were collected from all four provinces of Pakistan by non-medical interviewers and collated centrally. Measures to ensure data integrity were preventative, detective and corrective. We carefully selected and trained the interviewers, set rules of conduct and gave specific warnings regarding the consequences of falsification. We employed two-fold fraud detection methods: comparative data analysis, and face-to-face re-contact with randomly selected participants. When fabrication was detected, data shown to be unreliable were replaced by repeating the survey in new samples according to the original protocol. RESULTS: Comparative analysis of datasets from the regions revealed unfeasible prevalences and gender ratios in one (Multan). Data fabrication was suspected. During a surprise-visit to Multan, of a random sample of addresses selected for verification, all but one had been falsely reported. The data (from 840 cases) were discarded, and the survey repeated with new interviewers. The new sample of 800 cases was demographically and diagnostically consistent with other regions. CONCLUSION: Fraud in community-based surveys is seldom reported, but no less likely to occur than in other fields of medical research. Measures should be put in place to prevent, detect and, where necessary, correct it. In this instance, had the data from Multan been pooled with those from other regions before analysis, a damaging fraud might have escaped notice.

The burden of headache disorders in Pakistan: methodology of a population-based nationwide study, and questionnaire validation.

BACKGROUND: Large geographical gaps in our knowledge of the prevalence and burden of headache disorders include Pakistan, a country with major problems of poverty, illiteracy and security. We report implementation in this country of standard methods developed by Lifting The Burden (LTB) for population-based burden-of-headache studies. METHODS: We surveyed six locations from the four provinces: Lahore and Multan (Punjab), Karachi and Sukkur (Sindh), Abbottabad (Khyber Pakhtunkhwa) and Gwadar (Baluchistan). We randomly selected rural and urban households in each, which were visited by trained non-medical interviewers from the same locations. One randomly selected adult member (18-65 years) of each household was interviewed using LTB's structured questionnaire translated into Urdu, the national language. Validation was performed among patients and accompanying attendants in three (urban and rural) medical facilities. After responding to the questionnaire, these participants were re-interviewed and diagnosed by a neurologist (gold standard). RESULTS: The survey was completed by 4,223 respondents (1,957 [46.3%] male, 2,266 [53.7%] female, 1,443 [34.2%] urban, 2,780 [65.8%] rural, mean age 34.4 ± 11.0 years). The participation rate was 89.5%. There were 180 participants (46.1% male, 53.9% female, 41.7% urban, 58.3% rural, mean age 39.4 ± 14.2 years) in the validation sample, of whom 147 (81.7%) reported headache in the last year. The questionnaire was 100% sensitive in screening for headache and for headache on ≥15 days/month, and showed good agreement with the gold-standard diagnoses (kappa = 0.77). It was relatively insensitive for TTH. The questionnaire's default diagnosis of probable MOH when medication overuse accompanied headache on ≥15 days/month was not supported by evidence of causation in most cases seen by the neurologist. In public-health terms, precise diagnosis in these cases matters less than reliably detecting the coexistence of these disorders. CONCLUSION: In conclusion, the methods developed by LTB were applied successfully in Pakistan, despite problems unique to this country.